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Study Title Principal Investigator
A Phase II Study of Neratinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
Recruiting | Breast Cancer | Multisite
Cynthia Ma
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Assessing the Patient Experience in Cancer Care: An Observational Communication Study
Recruiting | Brain Cancer | Multisite
Jon Tilburt
1B-11-6-A Phase II, Multi-center, Open-label Study Evaluating GRN1005 Alone or in Combination with Trastuzumab in Breast Cancer Patients with Brain Metastases
Please see Brief Summary section.
Completed | Brain Cancer | Multisite
Debasish Tripathy
A Randomized, Phase II Clinical Trial of a Controlled Diet Prior to Selected Chemotherapy Treatment in Breast and Prostate Cancer to Evaluate the Impact on Toxicity and Efficacy
PRIMARY OBJECTIVES: I. To obtain preliminary estimates of the impact of a restricted diet on toxicity and efficacy of chemotherapy for breast and prostate cancer. II. To evaluate the compliance with a controlled diet intervention. III. To investigate changes in plasma insulin, glucose, insulin-like growth factor 1 (IGF1) and IGF binding protein (IGFBP) levels in subjects who consume a restricted diet compared to controls. OUTLINE: Patients are randomized to 1 or 2 treatment arms. ARM I: Patients eat a special low-calorie diet during 3 days prior to chemotherapy, during the 12 weeks of chemotherapy, and 24 hours after chemotherapy. Patients are provided with all meals and all food to be consumed and maintain a diary of the food consumed and appropriate amounts. Patients meet with the study dietician within 3 weeks of enrollment and prior to, or on the day of, their first course of chemotherapy on study and at the start of each subsequent course. ARM II: Patients eat a normal diet and receive dietary advice which may include consultation with a nutritionist. Patients maintain a diary of the food consumed and appropriate amounts.
Recruiting | Breast Cancer | Not Multisite
Tanya Dorff
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A Phase I/II Trial of Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer
Phase I Design A standard, 3+3, dose escalation schedule will be used. Between 6 and 12 patients will likely be necessary to determine the MTD of temsirolimus in combination with neratinib. There will be no intrapatient dose escalation. The starting dose of temsirolimus is 8 mg administered intravenously weekly (dose level 1). Three patients will initially be enrolled in each cohort. The Phase I portion is closed to enrollment. Phase II Design The phase II portion of this trial will be comprised of two cohorts—HER2-amplified and triple negative breast cancer—each of which has a Simon two-stage design to determine the efficacy of temsirolimus when administered in combination with neratinib. Both pathologic subtypes of patients will be studied separately though accrual will be simultaneous. Response (RECIST criteria) will be assessed every 8 weeks (every 2 cycles) after the start of therapy. As of 2/10/12, the Triple-negative cohort is closed to accrual. The HER2- amplified cohort will continue to enroll as planned up to a total of 34 patients.
Recruiting | Breast Cancer | Multisite
Puma Biotechnology
A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients With 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer With Recurrence Score (RS) of 25 or Less. RxPONDER: A Clinical Trial Rx for Positive Node, Endocrine Responsive Breast Cancer
PRIMARY OBJECTIVES: I. To determine the effect of chemotherapy in patients with node positive breast cancer who do not have high Recurrence Scores (RS) by Oncotype DX. In patients with 1-3 positive nodes, and hormone receptor (HR)-positive, human epidermal growth factor receptor (HER)2-negative breast cancer with RS =< 25 treated with endocrine therapy we will test whether the difference in disease-free survival for patients treated with chemotherapy compared to no chemotherapy depends directly on the magnitude of RS. If benefit depends on the RS score, the trial will determine the optimal cutpoint for recommending chemotherapy or not. SECONDARY OBJECTIVES: I. To compare overall survival (OS), distant disease-free survival (DDFS), and local disease-free interval (LDFI) by receipt of chemotherapy or not and its interaction with RS. II. To compare the toxicity across the treatment arms. III. To perform other assays or tests (in particular the PAM50 risk of relapse score) as they are developed and validated that measure potential benefit of chemotherapy and compare them to Oncotype DX. IV. To determine the impact of management with Oncotype DX on patient-reported anxiety (co-primary Health-Related Quality of Life [HRQL] outcome) prior to screening, after disclosure of test results, and during the randomized trial. V. To determine the impact of Oncotype DX on the initial management cost of node-positive, HR-positive, HER2-negative breast cancer. VI. To compare patient-reported utilities (e.g., QOL) for those randomized to chemotherapy versus no chemotherapy. VII. To estimate the cost-effectiveness of management with Oncotype DX vs usual care using modeling and DFS information from the trial. VIII. To determine the role of other assays (e.g., PAM50) as predictors of DFS, DDFS, and LDFI of patients randomized to chemotherapy versus no chemotherapy. IX. To determine the impact of treatment with chemotherapy versus no chemotherapy on patient-reported fatigue and cognitive concerns (secondary HRQL outcomes). X. To determine the impact of management with Oncotype DX on patient-reported decision conflict, perceptions regarding Oncotype DX testing, and survivor concerns prior to screening, after disclosure of test results, and during the randomized trial (secondary HRQL outcomes). OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive a protocol-approved chemotherapy regimen based on the patient and/or physician preference. Patients then receive a protocol-approved adjuvant endocrine therapy comprising tamoxifen citrate, an aromatase inhibitor (anastrozole, letrozole, or exemestane), or both for 5-10 years in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive a protocol-approved endocrine therapy comprising tamoxifen citrate, an aromatase inhibitor (anastrozole, letrozole, or exemestane), or both for 5-10 years in the absence of disease progression or unacceptable toxicity. Patients may complete health-related quality-of-life (QOL) questionnaires at baseline and periodically during study. Information on Medicare and/or insurance coverage and on health coverage decisions may also be collected periodically. After completion of study therapy, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then yearly for at least 15 years.
Recruiting | Breast Cancer | Multisite
Julie Gralow
Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients With High-Risk, Hormone Receptor-Positive and HER2/Neu Negative Breast Cancer
OBJECTIVES: Primary - To compare whether the addition of one year of everolimus (10 mg daily) to standard adjuvant endocrine therapy improves invasive disease-free survival (IDFS) in patients with high-risk, hormone-receptor (HR)-positive, and human epidermal growth factor receptor (HER)2-negative breast cancer. Secondary - To compare whether the addition of one year of everolimus to standard adjuvant endocrine therapy improves overall survival (OS) and distant recurrence-free survival (DRFS) in this patient population. - To evaluate the safety, toxicities, and tolerability of one year of everolimus in combination with standard adjuvant endocrine therapy and to compare it with standard adjuvant endocrine therapy plus placebo in this patient population. - To determine whether the benefit of one year of everolimus use in addition to standard adjuvant endocrine therapy varies by recurrence score (RS), nodal status, or other commonly used prognostic factors. - To evaluate adherence to 1-year treatment of everolimus in comparison to placebo in addition to standard adjuvant endocrine therapy in this patient population. - To collect specimens in order to evaluate biomarkers of therapeutic efficacy. (exploratory) OUTLINE: This is a multicenter study. Patients are stratified according to risk level (node-negative and recurrence score [RS] > 25 in the primary tumor, and a tumor measuring ≥ 2 cm in greatest diameter treated with adjuvant therapy vs 1-3 positive lymph nodes and RS > 25 treated with adjuvant therapy vs ≥ 4 positive lymph nodes [any RS value] treated with adjuvant therapy vs ≥ 4 positive lymph nodes [any RS value] prior to or after neoadjuvant chemotherapy). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive an approved endocrine therapy comprising tamoxifen citrate*, goserelin acetate** or leuprolide acetate**, or aromatase inhibitor (anastrozole, letrozole, or exemestane) for 2-5 years. Patients also receive a placebo orally (PO) daily for 1 year in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive an approved endocrine therapy regimen as in arm I. Patients also receive everolimus PO daily for 1 year in the absence of disease progression or unacceptable toxicity. NOTE: *Men receive tamoxifen citrate PO for 5 years. NOTE: **Goserelin acetate or leuprolide acetate is given if patient is or becomes postmenopausal. Blood and tissue samples are collected for biomarker studies. After completion of study treatment, patients are followed up every 6 months for 2 years and then yearly thereafter for 10 years.
Recruiting | Breast Cancer | Multisite
Mariana Chavez-MacGregor
A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients With Metastatic Breast Cancer
OBJECTIVES: Primary - To evaluate whether early local therapy comprising surgery of intact primary disease compared to local palliative therapy only in patients with stage IV breast cancer, whose disease does not progress during initial optimal systemic therapy, will result in prolonged survival. Secondary - To compare the time to uncontrolled chest wall disease between patients treated with these regimens. - To determine whether there is a difference in health-related quality-of-life (HRQOL) between patients treated with these regimens. - To determine whether the absolute value of circulating tumor cells (CTC) burden at 6 months following randomization (time +6) will be lower in the palliative therapy arm than in early local therapy arm, and whether this value is inversely related to survival (lower CTC, longer survival). - To collect tumor and blood specimens for future exploration of the biological interactions between the primary tumor and metastatic lesions and the effect of primary tumor resection. OUTLINE: This is a multicenter study. Patients are stratified according to hormone receptor and treatment plan (ER+ or PR+, HER2-, endocrine therapy alone vs ER+ or PR+, and HER2-, chemotherapy and/or endocrine therapy vs ER- or PR-, and HER2- vs HER2+), and number of involved organ systems with distant disease (regional nodes in the axillary, supraclavicular, and internal mammary locations are not considered distant sites) (1 vs > 1). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive standard palliative therapy, if needed, to address symptoms such as tumor ulceration, pain, bulky adenopathy causing arm symptoms, and other similar situations. Therapy may consist of radiotherapy alone, surgery alone, or a combination of both. - Arm II: Patients undergo surgery comprising breast-conserving therapy (BCT) or total mastectomy according to patient and treating physician preference. Surgery is to occur no later than 10 weeks after completion of 32 weeks of systemic therapy. Free surgical margins must be achieved with re-excision or mastectomy for patients undergoing BCT. After completion of BCT, patients undergo radiotherapy once a day, 5 days per week. Patients who had mastectomy undergo radiotherapy at the discretion of treating physician. Patients may undergo blood and tumor tissue sample collection for circulating tumor cells (CTC) burden and future studies. Patients complete the Functional Assessment of Cancer Therapy - Breast Trial Outcome Index (FACT- TOI) and FACT - General (22) and the Breast Cancer Subscale (FACT-B) quality-of-life questionnaires at baseline and periodically during study. After completion of study therapy, patients are followed up periodically for 5 years.
Recruiting | Breast Cancer | Multisite
Seema Khan
Combined Exercise Program for Early Breast Cancer Survivors
PRIMARY OBJECTIVES: I. To determine whether a 16-week exercise intervention will improve components of metastasis (MetS) in breast cancer survivors soon after completion of cancer-related treatments by measuring changes in body composition, waist circumference, blood pressure, and serum levels of insulin, glucose, lipids, C-reactive protein, and hemoglobin A1c (HbA1c). II. To determine whether a 16-week exercise intervention will improve physical fitness in breast cancer survivors soon after completion of cancer-related treatments by measuring cardiorespiratory fitness and muscle strength. III. To assesses the feasibility of a supervised exercise intervention in early breast cancer survivors. IV. To determine whether a 16-week exercise intervention will result in a reduction in adipose tissue inflammation in obese breast cancer survivors soon after completion of cancer-related treatments by measuring ATM phenotype and ATM cytokine expression. V. To determine whether breast cancer survivors can maintain positive benefits of an exercise intervention following a 12-week follow-up period by measuring changes in body composition, waist circumference, blood pressure, and serum levels of insulin, glucose, lipids, C-reactive protein, and HbA1c, cardiorespiratory fitness and muscle strength. OUTLINE: Patients are randomized to 1 of 2 arms. Arm I (Control): Patients refrain from increasing physical activity levels for 16 weeks. Arm II (Exercise): Patients participate in supervised exercise sessions over 60 minutes thrice weekly and are encouraged to participate in a home-based exercise session over 30-45 minutes once weekly for 16 weeks.
Recruiting | Breast Cancer | Not Multisite
Christina Dieli-Conwright
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1B-12-11: A Phase III Randomized, Double Blind Placebo Controlled Study of BKM120 with Fulvestrant, in Postmenopausal Women with Hormone receptor-positive HER2-negative Locally Advanced or Metastatic Breast Cancer which Progressed on or after Aromatase Inhibitor Treatment
Active, not recruiting | Breast Cancer | Multisite
Darcy Spicer
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1B-11-2-A Phase II, Randomized, Multicenter Study of CDX-011 (CR011-vcMMAE) in Patients with Advanced GPNMB-expressing Breast Cancer
CDX-011 consists of an antibody attached to a drug, monomethyl auristatin E (MMAE), that can kill cancer cells. The antibody delivers the drug to cancer cells by attaching to a protein called glycoprotein NMB (GPNMB) that is expressed on the cancer cell. The MMAE is then released inside of the cell, where it interferes with cell growth and may lead to cell death. This study will examine the effectiveness and safety of CDX-011 in patients with advanced breast cancer that makes the GPNMB protein. To better assess this, the effect of CDX-011 will be compared to treatment with currently available cancer chemotherapy. Eligible patients who enroll in the study will be randomly assigned by chance to receive treatment with CDX-011 or with a chemotherapy chosen by their study doctor from a list of currently available drugs ("Investigator's Choice" chemotherapy). For each three patients enrolled, two will receive CDX-011 and one will receive treatment with "Investigator's Choice". Patients initially assigned to "Investigator's Choice" chemotherapy may be offered treatment with CDX-011 if their cancer worsens during this initial treatment. All patients enrolled in the study will be closely monitored to determine if their cancer is responding to treatment, and for any side effects that may occur.
Completed | Breast Cancer | Multisite
Agustin Garcia
A Phase II-R and a Phase III Trial Evaluating Both *Erlotinib (PH II-R) and Chemoradiation (PH III) as Adjuvant Treatment For Patients With Resected Head of Pancreas Adenocarcinoma
PRIMARY OBJECTIVES: I. To determine whether the addition of erlotinib (erlotinib hydrochloride) to gemcitabine (gemcitabine hydrochloride) adjuvant chemotherapy shows a signal for improved survival as compared to gemcitabine alone following R0 or R1 resection of head of pancreas adenocarcinoma (including adenocarcinoma of the head, neck, and uncinate process). (Phase II-R) II. To determine whether the use of concurrent fluoropyrimidine and radiotherapy following adjuvant gemcitabine hydrochloride-based chemotherapy further enhances survival for such patients who are without evidence of progressive disease after 5 cycles of gemcitabine based chemotherapy. (Phase III) SECONDARY OBJECTIVES: I. To evaluate disease-free survival of adjuvant chemotherapy followed by radiotherapy and concurrent fluoropyrimidine for patients with resected head of pancreas adenocarcinoma who are disease free after 5 cycles of adjuvant chemotherapy. II. To evaluate disease-free survival of standard adjuvant gemcitabine chemotherapy with and without erlotinib for patients with resected head of pancreas adenocarcinoma. III. To evaluate adverse events with and without erlotinib for patients with resected head of pancreas adenocarcinoma. IV. To evaluate adverse events of adjuvant chemotherapy with or without radiation therapy and concurrent fluoropyrimidine for patients with resected head of pancreas adenocarcinoma who are disease free after adjuvant chemotherapy. V. To evaluate preoperative cross-sectional imaging of the primary head of pancreas adenocarcinoma in order to determine the frequency with which objective criteria of resectability are present. VI. To determine if patients reporting low baseline fatigue, as measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, predicts survival and to explore correlations between baseline fatigue, as measured by Patient-Reported Outcomes Measurement Information System (PROMIS), and survival. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive gemcitabine hydrochloride as in arm I and erlotinib hydrochloride orally (PO) once daily on days 1-28. Treatment repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity. (NOTE: Phase II-R erlotinib hydrochloride randomization completed, Arm 2 closed to accrual effective 2/19/2014) Patients with no disease progression after treatment in arm I or II are then stratified according to their first randomization treatment arm (arm I vs arm II) and randomized to 1 of 2 additional treatment arms (arm III or IV). ARM III: Patients receive 1 course of the same treatment that they receive in arm I or II. ARM IV: Patients receive 1 course of the same treatment that they receive in arm I or II. Beginning within 7-21 days after completion of chemotherapy, patients undergo radiotherapy (3-dimensional conformal radiotherapy or intensity-modulated radiotherapy) 5 days per week for 5.5 weeks (28 fractions). During radiotherapy, patients receive either capecitabine PO twice daily (BID) 5 days per week or fluorouracil IV continuously for 5.5 weeks or until radiotherapy is completed. After completion of study treatment, patients are followed up periodically.
Recruiting | Breast Cancer | Multisite
Ross Abrams
A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (CT1-3 N1) who Have Positive Sentinel Lymph Node Disease after Neoadjuvant Chemotherapy
Study Outline: - All patients will undergo surgery to identify sentinel lymph node(s). If a lymph node (sentinel or non-sentinel) is determined to be positive on intra-operative pathology the patient will be registered/randomized intra-operatively. - Patients who do not have a sentinel lymph node identified will not be registered/randomized to the study. - Patients whose sentinel lymph node status is cannot be/is not determined intra- operatively, and have not undergone ALND, but had at least one lymph node (sentinel or non-sentinel) found to be positive on final pathology review will be registered/randomized post-operatively. - Patients whose sentinel lymph node status is found to be negative intra-operatively and have not undergone ALND, but had at least one lymph node (sentinel or non-sentinel) found to be positive on final pathology review will be registered/randomized post-operatively. - ALND is not to be performed prior to registration/randomization. - Patients who are determined to have negative lymph nodes on final pathology will not be registered/randomized, but can be offered participation in another cooperative group trial. The primary and secondary objectives of the study are described below. Please see the "Arms" section for a detailed description of the treatment regimens. Primary Objective: - To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of invasive breast cancer recurrence-free interval in patients with positive SLN(s) after completion of neoadjuvant chemotherapy Secondary Objectives: - To evaluate whether radiation to the undissected axilla and regional lymph nodes is not inferior to axillary lymph node dissection with radiation to the regional lymph nodes but not to the dissected axilla in terms of the incidence of invasive loco-regional recurrences in patients with a positive SLN(s) after completion of neoadjuvant chemotherapy - To obtain an estimate of the distribution of residual disease burden scores for each treatment arm - To estimate the distribution of overall survival for each treatment arm Patients may receive adjuvant and ancillary therapy as appropriate per the protocol. Adjuvant Therapy: - Adjuvant endocrine therapy: Patients with hormone receptor (ER and/or PR) positive disease should receive a minimum of 5 years of standard endocrine therapy (experimental agents/regimens are not permitted). Endocrine therapy should begin following completion of neoadjuvant chemotherapy and surgery, either before, during or after radiation therapy at the discretion of the oncologist. Selection of the agents is at the treating physician's discretion. - Patients with HER 2 positive disease should complete a total of one year of trastuzumab therapy (over the neoadjuvant and adjuvant period). - Chemotherapy, biologic therapy or vaccine therapy in the adjuvant setting is not allowed. Patients who wish to receive any of these therapies after surgery must go off study at the time of their initiation. Ancillary Therapy: - Patients should receive full supportive care, including transfusions of blood and blood products, erythropoetin (unless otherwise specified in the protocol), antibiotics, antiemetics, etc. when appropriate. Patients are followed up for 5 years after completion of radiation therapy.
Recruiting | Breast Cancer | Multisite
Heather MacDonald
1B-12-10 Phase II Trial of Metronomic Capecitabine and Cyclophosphamide with Lapatinib and Trastuzumab in Patients with HER2 Positive Metastatic Breast Cancer Who Have Progressed on a Previous Trastuzumab-Based Regimen
Breast cancer is the most frequently diagnosed cancer and the second leading cause of cancer death in women. About 20% of patients will initially be diagnosed with breast cancer that has spread (metastatic), and 20-80% of patients initially diagnosed with localized disease will ultimately develop metastatic disease. Despite recent advances in therapy, metastatic breast cancer (MBC) remains an incurable disease and further improvements in systemic therapy are needed. Chemotherapy is usually given at the highest possible dose that does not cause life-threatening side effects. This dose does not target tumor cells specifically, but damages normal cells and results in toxic side effects that require time between each dose for recovery. Metronomic chemotherapy is an emerging new model in cancer therapy, in which low doses of chemotherapy drugs are given at frequent intervals. The major advantage of metronomic chemotherapy is the low toxicity, which significantly improves patients quality of life, allows for longer administration of chemotherapy drugs without dose reductions or delays, and provides opportunities to combine different classes of drugs that would otherwise be difficult with full dose regimens. Metronomic chemotherapy has been found to have moderate activity with low toxicity in several phase II clinical trials in patients with MBC and improved activity was seen in studies when it was combined with targeted therapies. Human epidermal growth factor receptor 2 (HER2) is overexpressed in about 20-30% of all breast cancers and is associated with earlier recurrence and shorter overall survival. Trastuzumab, a targeted therapy against HER2, improves survival in HER2 positive patients and when combined with chemotherapy has response rates that are 60-70%. However, patients eventually progress after initial response, but trastuzumab is usually continued in these patients even after their disease progresses. Lapatinib is an orally active small molecule that inhibits the tyrosine kinases of HER2 and epidermal growth factor receptor type 1 (EGFR). A phase III, randomized, open-label study showed that lapatinib in combination with capecitabine is also active in women with HER2-positive MBC who had previously received trastuzumab and is now the standard treatment in patients whose disease has progressed after treatment with trastuzumab. Other studies combining trastuzumab with lapatinib suggest that inhibiting HER2 with both drugs is better than using either drug alone in the treatment of HER2-positive breast cancer.This study proposes a phase II clinical trial using metronomic chemotherapy (capecitabine and cyclophosphamide), in combination with dual HER2 inhibition (lapatinib and trastuzumab), in HER2 positive MBC patients previously treated with trastuzumab. The primary objective of this study is to estimate the progression free survival (PFS) in patients with MBC that is HER2 positive and who have had previous treatment with trastuzumab.Patients who will be enrolled for this study will have laboratory confirmed HER2-positive breast cancer whose disease has spread and have had prior treatment with trastuzumab. Once participants sign the informed consent and are deemed eligible for the study, participants will receive either cyclophosphamide, cytoxan, lapatinib, and trastuzumab. They will take cyclophosphamide, cytoxan, lapatinib once a day and receive an injection of trastuzumab every 21 days. Every 21 days is called a cycle. During the study, participants will have the following procedures done during each cycle: a physical exam, blood tests, performance status, assessment of side effects, and review of medications. They will have tumor assessments every 2 cycles with radiographic scans and MUGA or Echo to assess heart function every 3 cycles. Participants will stop taking study drug(s) if their disease worsens, they have another illness which prevents them from taking the study drug(s), they cannot tolerate the side effects, they withdraw from the study, or their study doctor thinks that being on the study is no longer in their best interest. Participants will be followed every 3 months for one year after stopping the study drugs.The primary endpoint for participants is PFS. One-sided one-sample logrank test will be used to evaluate the improvement in PFS compared to the reported historical PFS rate. One futility analysis will be performed during the trial, at the end of the 1st year after enrollment starts using the Hazard Ratio for progression.
Recruiting | Breast Cancer | Not Multisite
Darcy Spicer
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1B-13-11-A Phase III, Randomized, Open Label, Multicenter, Controlled Trial of Niraparib versus Physicians Choice In Previously-Treated, HER2 Negative, Germline BRCA Mutation-Positive Breast Cancer Patients
This study is for individuals that have breast cancer that has progressed under the current best standard treatment and because you were also found to be a carrier of an inherited BRCA1 or BRCA2 gene mutation (change).Niraparib is a PARP inhibitor. These drugs selectively kill cancer cells by affecting the DNA repair mechanism (DNA contains our unique hereditary information, the genetic code). A harmful mutation in a BRCA gene is a defect in the DNA repair mechanism. Individuals carrying such mutation are more prone to respond to the experimental drug niraparib. Niraparib has been developed to address DNA repair defects, and has been shown to be effective in previous tests.The purpose of this study is to compare the effects, both good and/or bad, of treating subjects with either niraparib or with the standard chemotherapy for this type of breast cancer to find out which is better.The endpoints for this study are: progression free survival (PFS) assessed by blinded, review between participants randomized to the study drug versus the physician's choice.; overall survival between participants randomized to the study drug versus physician's choice; safety and tolerability, described using frequency of AEs and AEs of more that grade 3. Safety analysis will include all participants who have received at least one dose of study drug and will be evaluated descriptively.The primary analysis of PFS and OS will be analyzed using a non-stratified log- rank. Futility analyses are planned after 35 and 96 PFS events. If the results cross the pre-specified futility boundary, the IDMC may recommend stopping the study.This is a phase 3 superiority trial study. No crossover to the study drug is permitted following discontinuation from physician's choice treatment.Randomization will be 2:1 (treatment control). At least 306 participants will participate in this study. Approximately 204 of them will receive treatment with niraparib and the rest, approximately 102 will be allocated to receive a standard chemotherapy drug which is already approved for breast cancer that has progressed. The intent-to-treat population, defined as all randomized participants, is the primary analysis population for the efficacy analysis.The study drug, niraparib, 300 mg (3x100 mg niraparib capsules) will be administered orally QD continuously in an open- label fashion. Patients will be required to fast for at least 2 hours before each daily dose and for 2 hours after each daily dose.The Physician's choice (eribulin, vinorelbine, gemcitabine or capecitabine) chemotherapy will be administered in 3 week cycles. The physicians choice chemotherapy must be designated prior to randomization of each participant. Patients will continue on study medication until disease progression as long as in the investigator's opinion they are benefiting from treatment and do not meet any other treatment discontinuation criteria.
Active, not recruiting | Breast Cancer | Multisite
Christy Russell
CTSU_NSABP-51/RTOG 1304 - A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and - Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy
PRIMARY OBJECTIVES: To evaluate whether the addition of chest wall + regional nodal radiation therapy (XRT) after mastectomy or breast + regional nodal XRT after breast conserving surgery will significantly reduce the rate of events for invasive breast cancer recurrence-free interval (IBC-RFI) in patients who present with histologically positive axillary nodes but convert to histologically negative axillary nodes following neoadjuvant chemotherapy. SECONDARY OBJECTIVES: I. To evaluate whether the addition of chest wall + regional nodal XRT after mastectomy or breast + regional nodal XRT after breast conserving surgery will significantly prolong overall survival (OS) in patients who present with histologically positive axillary nodes but convert to histologically negative axillary nodes following neoadjuvant chemotherapy. II. To evaluate whether the addition of chest wall + regional nodal XRT after mastectomy or breast + regional nodal XRT after breast conserving surgery will significantly reduce the rates of events for local-regional recurrence-free interval (LRRFI) in patients who present with histologically positive axillary nodes but convert to histologically negative axillary nodes following neoadjuvant chemotherapy. III. To evaluate whether the addition of chest wall + regional nodal XRT after mastectomy or breast + regional nodal XRT after breast conserving surgery will significantly reduce the rate of events for distant recurrence-free interval (DRFI) in patients who present with histologically positive axillary nodes but convert to histologically negative axillary nodes following neoadjuvant chemotherapy. IV. To compare the rates of disease-free survival (DFS)-ductal carcinoma in situ (DCIS) by treatment arm. V. To compare the rates of second primary cancer (SPC) by treatment arm. VI. To compare the effect of adding XRT on the cosmetic outcomes in mastectomy patients who have had reconstruction. VII. To compare the effect of adding XRT on quality of life including arm problems, lymphedema, pain, and fatigue. VIII. To evaluate the toxicity associated with each of the radiation therapy regimens. IX. To determine whether computed tomography (CT)-based conformal methods (intensity-modulated radiation therapy [IMRT] and 3-dimensional conformal radiation therapy [3DCRT]) for chestwall + regional nodal XRT post mastectomy and regional nodal XRT with breast XRT following breast conserving surgery are feasible in a multi-institutional setting and whether dose-volume analyses can be established to assess treatment adequacy and to develop normal tissue complication probabilities (NTCP) for the likelihood of toxicity. X. To compare the effect of XRT in patients receiving mastectomy and in patients receiving lumpectomy. XI. To examine the role of proliferation measures as a prognosticator for patients with residual disease after neoadjuvant chemotherapy. XII. To develop predictors of the degree of reduction in local regional recurrence (LRR). OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM 1: Patients are assigned to 1 of 2 treatment groups. GROUP 1A: Lumpectomy patients undergo whole breast radiation therapy using IMRT or 3DCRT once daily 5 days a week for 5 weeks followed by a radiation therapy boost to the lumpectomy cavity once daily 5 days a week for 1-1/2 weeks. GROUP 1B: Mastectomy patients do not undergo radiation therapy. ARM 2: Patients are assigned to 1 of 2 treatment groups. GROUP 2A: Lumpectomy patients undergo regional nodal radiation therapy with whole breast radiation therapy using IMRT or 3DCRT once daily 5 days a week for 5 weeks followed by a radiation therapy boost to the lumpectomy cavity once daily 5 days a week for 1-1/2 weeks. GROUP 2B: Mastectomy patients undergo regional nodal radiation therapy and chestwall XRT using IMRT or 3DCRT once daily 5 days a week for 5 weeks. All patients also receive systemic therapy as planned (hormonal therapy for patients with hormone-receptor positive breast cancer and trastuzumab or other anti-human epidermal growth factor receptor 2 [HER2] therapy for patients with breast cancer that is HER2-positive). After completion of study treatment, patients are followed up at 6, 12, 18, and 24 months and then yearly for 8 years.
Recruiting | Breast Cancer | Multisite
Eugene Chung
1B-14-2: A Phase II, Open-Label, Multi-Center Study of ANG1005 in Breast Cancer Patients with Recurrent Brain Metastases
See above.
Active, not recruiting | Brain Cancer | Multisite
Agustin Garcia
1B-11-3 PhII-117 Phase II Study of Azacitidine and Entinostat (SNDX-275) in Patients with Advanced Breast Cancer
PRIMARY OBJECTIVES: I. To evaluate objective response rate by Response Evaluation Criteria In Solid Tumors (RECIST) criteria of the combination of azacitidine (5-AZA) and entinostat in women with advanced breast cancer; triple-negative and hormone-refractory. SECONDARY OBJECTIVES: I. To determine the safety and tolerability of the combination of 5-AZA and entinostat in women with advanced breast cancer. II. To determine progression-free survival, overall survival, and clinical benefit rate of the combination of 5-AZA and entinostat. TERTIARY OBJECTIVES: I. To collect safety and toxicity data as well as the feasibility and response rate where hormonal therapy is added to the combination under investigation at the time of progressive disease. (Exploratory) II. To determine the pharmacokinetic profile of 5-AZA (full profile) and entinostat (trough concentrations) in patients with advanced breast cancer. (Exploratory) III. To assess serum cytidine deaminase pharmacogenetics and phenotypic activity as a potential biomarker of response to 5-AZA. (Exploratory) IV. To evaluate baseline and change in candidate gene re-expression (e.g., estrogen receptor [ER] alpha, retinoic acid receptor [RAR] beta) in malignant tissue obtained from selected patients through fine-needle aspiration (FNA) and core biopsy, prior to and following combination therapy. (Exploratory) V. To evaluate baseline and change in gene methylation silencing in circulating deoxyribonucleic acid (DNA) obtained prior to and following combination therapy. (Exploratory) VI. To evaluate baseline and change in gene methylation in malignant tissue obtained through FNA and core biopsy. (Exploratory) OUTLINE: This is a multicenter study. Patients receive azacitidine subcutaneously (SC) on days 1-5 and 8-10, and entinostat orally (PO) on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue azacitidine and entinostat in combination with hormonal therapy, at treating physician discretion, or undergo event monitoring. After completion of study therapy, patients are followed up every 3-6 months for up to 3 years.
Active, not recruiting | Breast Cancer | Multisite
Agustin Garcia
1B-14-1: A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating Safety and Efficacy of the Addition of Veliparib Plus Carboplatin Versus the Addition of Carboplatin to Standard Neoadjuvant Chemotherapy Versus Standard Neoadjuvant Chemotherapy in Subjects with Early Stage Triple Negative Breast Cancer (TNBC)
Active, not recruiting | Breast Cancer | Multisite
Christy Russell
A Phase 2, Open-label, Multicenter, Safety and Efficacy Study of Oral Lucitanib in Patients With FGF Aberrant Metastatic Breast Cancer
Lucitanib is a selective, orally available tyrosine kinase inhibitor targeting FGFR1-3, VEGFR1-3, and PDGFRα and β, with activity in relevant cell lines and animal models. The first in human trial of lucitanib demonstrated that daily dosing with lucitanib can provide durable clinical responses in patients with FGFR1- or 11q (FGF3, FGF4, Cyclin D1, or FGF19)-amplified breast cancer. RECIST partial responses (PRs) were also observed in patients not known to have FGF abnormalities. Based on these results, is study is designed to explore the safety and anti-tumor activity of daily lucitanib in breast cancer patients with and without alterations of the FGF pathway.
Recruiting | Breast Cancer | Multisite
Jason Litten
Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women With Breast Cancer
This is a randomized trial of preoperative breast MRI in patients deemed eligible for breast conserving surgery by conventional clinical criteria will provide important information about the clinical and biologic relevance of occult disease identified by MRI alone. Patients will be assigned to standard pre-operative breast cancer disease assessment without the addition of MRI prior to breast conserving surgery or standard pre-operative breast cancer disease assessment with the use of MRI prior to breast conserving surgery. The primary objective is to compare the rates of local-regional recurrence (LRR) following attempted breast conserving therapy in a cohort of women with triple negative or HER-2 amplified breast cancer randomized to preoperative staging with mammography (control arm) or mammography plus breast MRI (MRI arm). Secondary objectives are: - To compare the re-operation rates following attempted breast conserving therapy between women assessed preoperatively with breast MRI to those assessed without the use of breast MRI - To compare local recurrence rates between women who undergo BCT on the control arm to women who undergo BCT on the MRI arm - To compare the conversion rate to mastectomy secondary to persistent positive margins or poor cosmesis within the first 6 months of attempting BCT (prior to the administration of RT) between women assessed preoperatively with breast MRI to those assessed without the use of breast MRI - To compare the contralateral breast cancer rates in women randomized to preoperative breast MRI to those not receiving pre-operative breast MRI - To compare the disease-free survival rates between women assessed preoperatively with breast MRI to those assessed without the use of breast MRI - To compare breast cancer specific and overall survival outcomes of women assessed preoperatively with breast MRI to those assessed without the use of breast MRI - To estimate the rate of MRI-guided localization assisted surgery - To estimate the rate of multi-centric disease in the index breast for women in the MRI arm - To evaluate the accuracy of index lesion characteristics and other factors in predicting multi-centricity in the cohort randomized to breast MRI - To assess the positive predictive values (PPV) of MRI in detecting ipsilateral multi-centric disease and contralateral disease in women with breast cancer undergoing preoperative breast MRI - To estimate the false positive rate for detection of multiple foci of breast cancer by MRI All registered patients will be monitored for relapse and survival for 5 years from the date of surgery. Patients will be followed a minimum of every 4 months for the first 2 years from diagnosis and a minimum of every 6 months during years 3-5. Patients will be monitored for local, regional, distant relapse and vital status.
Recruiting | Breast Cancer | Multisite
Isabelle Bedrosian
RTOG-1005 A Phase III Trial of Accelerated Whole Breast Irradiation With Hypofractionation plus Concurrent Boost versus Standard Whole Breast Irradiation plus Sequential Boost for Early-Stage Breast Cancer
OBJECTIVES: Primary - To determine whether an accelerated course of hypofractionated whole-breast irradiation (WBI) including a concomitant boost to the tumor bed in 15 fractions following lumpectomy will prove to be non-inferior in local control to a regimen of standard WBI with a sequential boost following lumpectomy for early-stage breast cancer patients. Secondary - To determine whether breast-related symptoms and cosmesis from accelerated WBI that is hypofractionated (in only 3 weeks) with a concomitant boost is non-inferior to standard WBI with sequential boost. - To determine whether the risk of late cardiac toxicity in patients with left-sided breast cancer treated with hypofractionation will be non-inferior to conventional fractionated radiation therapy (RT) based upon analysis of radiation dosimetry from CT-based treatment planning and NTCP calculations. - To determine whether CT-based conformal methods intensity-modulated radiation therapy (IMRT) and three-dimensional conformal radiotherapy (3D-CRT) for WBI are feasible in a multi-institutional setting following lumpectomy in early-stage breast cancer patients and whether dose-volume analyses can be established to assess treatment adequacy and likelihood of toxicity. - To determine that cosmetic results and breast-related symptoms 3 years after hypofractionated breast radiation with concomitant boost will not be inferior to that obtained 3 years after WBI with sequential boost. - To determine whether future correlative studies can identify individual gene expressions and biological host factors associated with toxicity and/or local recurrence from standard and hypofractionated WBI. - If shown to be non-inferior, to then determine if accelerated course of hypofractionated WBI including a concomitant boost to the tumor bed in 15 fractions following lumpectomy will prove to be superior in local control to a regimen of standard WBI with a sequential boost following lumpectomy for early-stage breast cancer patients. - To determine whether treatment costs for hypofractionated WBI with concomitant boost are not higher than WBI with sequential boost. OUTLINE: This is a multicenter study. Patients are stratified according to age (< 50 vs. ≥ 50 years), prior chemotherapy (yes vs. no), estrogen-receptor status (+ vs. -), and histology grade (1-2 vs. 3). Patients are randomized to 1 of 2 treatment arms. Treatment begins within 9 weeks of last surgery or chemotherapy delivery. - Arm I: Patients undergo standard whole-breast radiotherapy (WBI) comprising intensity-modulated radiation therapy (IMRT) or three-dimensional conformal radiotherapy (3D-CRT) 5 days a week for 3-5 weeks followed by a sequential radiotherapy boost to the lumpectomy area 5 days a week for 1-1½ weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. - Arm II: Patients undergo accelerated hypofractionated WBI comprising IMRT or 3D-CRT with a concurrent boost to the lumpectomy area 5 days a week for 3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients' tissue samples may be collected for future research studies. After completion of study therapy, patients are followed at 1 month, at 6 months, and then yearly.
Active, not recruiting | Breast Cancer | Multisite
Afshin Rashtian
1B-14-3 A Randomized, Double-Blind, Phase 2 Study of Ruxolitinib or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-Negative Breast Cancer
Active, not recruiting | Breast Cancer | Multisite
Agustin Garcia
A Phase 2, Multicenter, Open-label Study to Assess the Efficacy and Safety of Enzalutamide with Trastuzumab in Subjects with HER2+ AR+ Metastatic or Locally Advanced Breast Cancer
Active, not recruiting | Breast Cancer | Multisite
Agustin Garcia
0S-11-4 PhII-118 ABT-888 Phase II Randomized Trial of the Combination of ABT-888 With Metronomic Oral Cyclophosphamide in Refractory BRCA-Positive Ovarian, Primary Peritoneal or Ovarian High-Grade Serous Carcinoma, Fallopian Tube Cancer, Triple-Negative Breast Cancer, and Low-Grade Non-Hodgkins Lymphoma
Background: - The poly (ADP-ribose) polymerase (PARP) family of enzymes is critical for maintaining genomic stability by regulating a variety of DNA repair mechanisms. - Individuals with deleterious mutations in the BRCA1 or BRCA2 tumor suppressor genes have an increased risk of developing breast and ovarian cancers due to impaired or defective DNA damage repair; these individuals have an increased susceptibility to DNA-damaging agents and PARP inhibitors. Inhibition of PARP inhibits the repair of DNA damage caused by alkylating agents such as cyclophosphamide. - Metronomic cyclophosphamide has demonstrated efficacy in several tumor types. The PARP inhibitor ABT-888 has been shown to potentiate the action of cyclophosphamide in xenograft models. This combination is well tolerated in a Phase I study and showing promising activity. Objectives: - Compare the response rate (complete response (CR) + partial response (PR)) of the combination of ABT-888 with metronomic oral cyclophosphamide to the response rate (CR+PR) of metronomic oral cyclophosphamide in patients with deleterious BRCA mutations and refractory ovarian cancer or patients with primary peritoneal or ovarian high-grade serous carcinoma or fallopian tube cancer. - Compare the response rate (CR+PR) of the combination of ABT-888 with metronomic oral cyclophosphamide to the response rate (CR+PR) of single-agent oral cyclophosphamide in patients with triple-negative metastatic breast cancer, stratified for deleterious BRCA mutation. - Compare the response rate (CR+PR) of the combination of ABT-888 with metronomic oral cyclophosphamide to the response rate (CR+PR) of single-agent metronomic oral cyclophosphamide in patients with refractory low-grade lymphomas. Secondary Objectives: - Determine PAR levels in tumor biopsies, evaluate in archival tissue whether patients tumors have mutations in genes involved in DNA damage repair (e.g., BRCA/Fanconi anemia/protein 53 (p53)), perform exploratory gene expression profiling to correlate PARP messenger ribonucleic acid (mRNA) levels or BRCA mutation status with response to therapy, count circulating tumor cells (CTCs), and determine H2AX levels in CTCs and tumor biopsies (National Cancer Institute (NCI) clinical center only). Eligibility: -Adults with refractory BRCA-positive ovarian cancer, primary peritoneal or ovarian high-grade serous carcinoma, fallopian tube cancer, triple-negative breast cancer, or low-grade lymphoid malignancies (non-Hodgkin's lymphoma) whose disease has progressed following at least one line of therapy. Study Design: - This is a randomized, multi-histology Phase II trial with patients enrolled into 3 cohorts: BRCA-positive ovarian cancer or primary peritoneal or ovarian high-grade serous carcinoma or fallopian tube cancer (A); triple-negative breast cancer (B); or low grade non-Hodgkin's lymphoma (C). Patients in cohort A will be randomized to the combination of ABT-888 with metronomic oral cyclophosphamide or metronomic oral cyclophosphamide alone. Patients in cohort B will be randomized to the combination of ABT-888 with metronomic oral cyclophosphamide or metronomic oral cyclophosphamide alone. Patients in cohort C will be randomized to the combination of ABT-888 with metronomic oral cyclophosphamide or metronomic oral cyclophosphamide alone. - Cyclophosphamide (50 mg) and ABT-888 (60 mg) will be administered orally once a day, continuously in 21-day cycles.
Completed | Breast Cancer | Multisite
Agustin Garcia
Changes in Intestinal Microbiota in Association with Chemotherapy Treatment
This pilot study represents a first step to collect the critical data (stool sample collections, DEXA scan, blood and urine collection) that will allow us to systemically study the role of the gut microbiota in relation to outcome in breast cancer patients. Objective:The overall objective of this application is to investigate the short-term and long-term effects of chemotherapy on the gut microbiota of 45 newly diagnosed breast cancer patients undergoing chemotherapy.Study Population:Participants must be 18 years of age or older with newly diagnosed ductal carcinoma in situ or invasive breast cancer (stage I, stage IIA, stage IIB, and stage IIIA breast cancer)Study Methodology:Longitudinal, observational, usual care.Study Arms:Plans A and B are for patients who will only get adjuvant chemotherapy but will not get neoadjuvant chemotherapy before their surgery.Plan C is for patients who will get neoadjuvant chemotherapy before their surgery but will not get adjuvant chemotherapy after surgery.Study Endpoints:The primary endpoints are changes in the gut microbiota. The secondary endpoints are baseline body composition (weight, BMI, waist and hip circumference, bone, fat and lean mass, and percent body fat) and estrogen levels as well as changes in body composition and estrogen levels.Follow-up:There will be 3 follow-up visits after baseline (SV1). These visits will take place in Dr. Wus private office suite which is located on the 4th floor of the Norris Topping Tower (Rm 4445).Statistics: With a sample size of 45 women, using a two-sided one-sample t-test at the alpha level of 0.05, we have 80% power to detect an average change in microbiota or body composition measure of 0.427 standard deviation.Analysis:All data collected (baseline questionnaires, clinical information, etc) at each of the three clinic visits will be checked and computerized on an ongoing basis. Prior to data entry, all forms will be reviewed for completeness and accuracy.
Recruiting | Breast Cancer | Not Multisite
Anna Wu
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1B-13-2 Core Biopsies of Breast Tumor Tissue Repository
The response to treatment varies considerably among breast cancer patients. Markers that can predict response to specific therapies have been difficult to identify and validate for several reasons: cell and animal models do not reflect human biology well, tumor tissue that has been fixed in preservative limits their analysis, and differences within tumors that may control drug response are not easily assessed in tissue sections. The study of human breast tumor tissue in patients at baseline and at timepoints following medical therapies can provide valuable insights into markers and pathways that mediate drug response and resistance. We aim to create a repository for future studies to develop and refine tissue assays and to generate pilot data on mediators of drug response/resistance that can then be validated on larger tissue cohorts from clinical trial databases and other outside repositories. In contrast to the more general breast and womens program tissue repository, this proposal is specifically for collecting core tumor biopsies performed on patients with breast cancers who are receiving anti-cancer therapy. The objective of this proposal is to prospectively obtain and bank core biopsies of breast cancers at the timepoints of diagnostic biopsy, surgery for tumor removal, and following chemotherapy in order to facilitate research focusing on tumor changes that drive drug resistance and spread to other organs.Patients enrolled in this registry will have suspected or known breast cancer and be able to provide additional core biopsy specimens over and above those needed for diagnosis and other required tests. There will be 4 groups of patients enrolled: 1) patients newly diagnosed with early stage breast cancer who will have surgery before receiving any chemotherapy, 2) patients newly diagnosed with breast cancer who will be receiving standard of care chemotherapy before surgery or patients with advanced disease that cannot be removed with surgery, 3) patients being evaluated for a suspicious breast mass that has a high likelihood of being cancer, and 4) patients with breast cancer that has returned or worsened. Consenting patients will have additional core needle biopsies of suspected or known breast tumors collected by the pathologist assigned to the case. Up to 6 additional core biopsies will be obtained through a single opening in the skin under ultrasound guidance by the research radiologist. For patients in whom a full diagnosis is not yet established, the additional core biopsy specimens will be held until the pathologist verifies that the diagnostic biopsy is sufficient for all needed diagnostic tests. If patients consent, another set of biopsies will be done at the time when their disease returns or worsens. Blood samples will be collected at baseline and at the time when disease returns or worsens. Medical records will be reviewed to collect information about medical history, family history, diagnosis, cancer treatments, lab test results, medications used, tumor measurements, and death. Participants will be followed every 6 months through chart review and telephone calls.Interested investigators and / or researchers who would like to obtain tissue or blood samples and / or associated data will submit their IRB-approved protocols for consideration to the Core Biopsy Steering Committee.
Recruiting | Breast Cancer | Not Multisite
Julie Lang
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1B-12-9: An Observational Cohort Study of Treatment Patterns and Outcomes in Patients with Her2 Positive (Her2+) Metastatic Breast Cancer
This is a multicenter, prospective, observational cohort study designed to follow patients with HER2+ MBC (Metastatic Breast Cancer) in the U.S. This observational cohort study (OCS) will provide important longitudinal follow-up of patients with HER2+ breast cancer across various stages to inform treatment strategy decision-making.The primary objective of this OCS is to describe temporal trends in treatment patterns as well as sequencing of treatments and clinical outcomes in patients with metastatic HER2+ breast cancer.A total of approximately 1000 patients will be enrolled out of which 20 will be enrolled at USC. Study duration subsequent to full accrual will be at least 5 years, ensuring a follow up of up to 8 years.Enrolled patients will have an initial diagnosis of HER2+ MBC that has not been previously treated with systemic therapy. They will receive treatment and evaluations for their HER2+ breast cancer as determined by their treating physicians, usually according to the standard of care and clinical practice at each study site.No treatment regimen will be protocol specified, and all treatments that patients receive for their HER2+ breast cancer will be collected. Participants will be asked to complete questionnaires at baseline and periodically throughout the study participation during site visits and at the time of disease progression to assess overall health status, activities of daily living, and other health issues. Patient-reported outcomes will be collected at baseline and periodically throughout study participation.An optional tissue and blood collection will be performed as part of this study.Primary endpoint is distribution of patients receiving unique treatment regimen or sequence of treatment regimens for HER2+ MBC.Secondary endpoints are:1. Progression-free survival (PFS)2. Overall Survival (OS)3. Post-progression survival (PPS) 4. Time to treatment failure (TTF)5. Response rate (RR)For descriptive summaries, continuous variables will be summarized using descriptive statistics. If applicable, analysis of variance (ANOVA)/model (t-test or F-test) or non-parametric testing such as Wilcoxon's rank sum test or Kruskal Wallis test will be used to test group difference on the continuous variables.Categorical variables will be summarized by numbers and proportions. If applicable, chi-square test will be used to test group difference on the categorical variables.
Active, not recruiting | Breast Cancer | Multisite
Darcy Spicer
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1B-13-8 Real Time Contrast Enhanced Ultrasound and Ultrasound-Based Elastography: Novel Techniques in Assessment of Treatment Response to Neoadjuvant Chemotherapy for Breast Cancer
PRIMARY OBJECTIVES: I. To establish a quantitative prediction rule for accurate and early prediction of the pathologic tumor response assessed post-surgery, using the change of contrast enhanced ultrasound (CEUS) assessed tumor size and perfusion characteristics before (baseline) and 2-3 weeks following initiation of neoadjuvant chemotherapy (NAC). II. To assess the agreement between CEUS based classification rule and pathologically determined treatment response (baseline versus pre-surgical scan). III. To establish a quantitative prediction rule for accurate and early prediction of the pathologic tumor response assessed post-surgery, using the change in propagation velocity of a shear mechanical wave in tissue before (baseline) and 2-3 weeks following initiation of NAC. IV. To assess the agreement between shear wave elastography (SWE) based classification rule and pathologically determined treatment response (baseline versus pre-surgical scan). SECONDARY OBJECTIVES: I. To explore the role of combined CEUS + SWE features obtained at early treatment phase (2-3 weeks following initiation of NAC), in accurately predicting the pathologically determined tumor response. II. To investigate the agreement in assessment of therapy response to NAC between CEUS versus contrast enhanced magnetic resonance imaging (CE MRI) and SWE versus CE MRI for baseline versus pre-surgery scan and to identify discordant cases using scatter plot and contingency tables. OUTLINE: Patients undergo dynamic contrast-enhanced ultrasound imaging and shear wave elastography at baseline, 2-3 weeks after initiation of chemotherapy, and before surgery.
Recruiting | Breast Cancer | Not Multisite
Linda Hovanessian Larsen
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1B-12-3-PRESENT: Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax" Treatment
This is a multicenter, multinational, prospective, randomized, double-blind, controlled Phase 3 study. The subjects eligible for this trial have an early stage node-positive breast cancer. Their tumors express low or intermediate levels of the HER2 protein. NeuVax™ will be administered after completion of front-line, standard of care therapy (surgery, radiation therapy, and chemotherapy) and can be given concomitantly with physician prescribed endocrine treatment. NeuVax™ is the immmunodominant nonapeptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. The nelipepimut sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTL) following binding to HLA-A2/A3 molecules on antigen presenting cells (APC). These activated specific CTLs recognize, neutralize and destroy through cell lysis HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading. Based on a successful Phase 2 trial, which achieved its primary endpoint of DFS, the Food and Drug Administration (FDA) granted NeuVax a Special Protocol Assessment (SPA) for its Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study. The active portion of the study will last three years (36 months). The follow-up will last from 5 to 10 years. Endpoints: 1. Primary efficacy endpoint: - 3-year DFS 2. Secondary efficacy endpoints: - 5- and 10-year DFS - 3-year OS - 5- and 10-year OS - Safety profile, and adverse events (AEs) - Patterns of recurrence to include Time to recurrence (TTR), time to local recurrence (TTLR), time to distant recurrence (TTDR), time to bone metastases (TTBM) Safety Assessments: Subjects will be assessed at every study visit for the safety endpoints, AEs,vital signs, physical examinations and laboratory data; yearly follow-up of survival will include imaging studies, ECGs, MUGA or ECHO scans and concomitant medications.
Completed | Breast Cancer | Multisite
Agustin Garcia
CTSU/NSABP-B43: A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy
PRIMARY OBJECTIVES: I. To determine the value of trastuzumab given during radiation therapy (RT) compared to RT alone in preventing subsequent occurrence of ipsilateral breast cancer recurrence, ipsilateral skin cancer recurrence, or ipsilateral ductal carcinoma in situ (IIBCR-SCR-DCIS) in women with human epidermal growth factor receptor 2 (HER2)-positive DCIS resected by lumpectomy. SECONDARY OBJECTIVES: I. Determine the value of trastuzumab given during RT compared to RT alone in prolonging invasive or DCIS disease-free survival (IDFS)-DCIS. II. Determine the value of trastuzumab given during RT compared to RT alone in increasing invasive or DCIS recurrence-free interval. III. Determine the value of trastuzumab given during RT compared to RT alone in improving regional or distant recurrence. IV. Determine the value of trastuzumab given during RT compared to RT alone in improving the incidence of contralateral invasive or DCIS breast cancer. V. Determine the value of trastuzumab given during RT compared to RT alone in improving survival. VI. To explore the effect of trastuzumab on ovarian function. TERTIARY OBJECTIVES: I. To determine if the benefit of trastuzumab added to RT will be significantly higher in v-myc avian myelocytomatosis viral oncogene homolog (cMYC)-amplified tumors than in the cMYC non-amplified subset. II. To determine if the benefit of trastuzumab added to RT will be less in tumors with mutations in the phosphatidylinositol 3 (PI3) kinase gene than in tumors without PI3 kinase gene mutations. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo standard whole breast irradiation (WBI) over 5-6 weeks. ARM II: Patients receive trastuzumab intravenously (IV) over 30-90 minutes once in weeks 1 and 4. Patients also undergo WBI as in Arm I. After completion of study treatment, patients are followed up every 6 months for 5 years and then every 12 months for 5 years.
Active, not recruiting | Breast Cancer | Multisite
Eugene Chung
1B-11-5: A Pilot Study to Evaluate the Efficacy of Fosaprepitant and Granisetron Transdermal System for the Prevention of Acute and Delayed Nausea and Vomiting in Breast Cancer Patients and to Identify Predictors of Response
PRIMARY OBJECTIVE: I. To evaluate the efficacy of the combination of fosaprepitant (fosaprepitant dimeglumine) and granisetron transdermal system in the prevention of acute and delayed chemotherapy induced nausea and vomiting in breast cancer patients undergoing adjuvant or neoadjuvant chemotherapy. SECONDARY OBJECTIVE: I. To evaluate the safety of the combination of fosaprepitant and granisetron transdermal system in breast cancer patients undergoing adjuvan or neoadjuvant chemotherapy. EXPLORATORY OBJECTIVE: I. To explore the use of single nucleotide polymorphisms (SNPs) in the 5âhydroxytryptamine-3 (5HT3) and neurokinin-1 (NK-1) receptors as potential markers of efficacy. OUTLINE: Patients receive granisetron transdermal system patch 24-48 hrs before the initiation of chemotherapy. Patients wear the granisetron transdermal system patch for 7 days. Patients receive fosaprepitant dimeglumine intravenously (IV) over 15 minutes on day 1 of chemotherapy. Treatment repeats every 2 or 3 weeks for up to 4 courses in the absence of unacceptable toxicity.
Terminated | Breast Cancer | Not Multisite
Agustin Garcia
1B-12-6 Light-Scattering Spectroscopy for the Detection of Stage II-III Breast Cancer: A Pilot Study
Breast cancer is the second leading cause of cancer death in women, and is the most frequently diagnosed cancer among women. The most common method for breast cancer screening is mammography, which is an x-ray of the breast. Although a mammogram may find tumors that are too small to feel, it has limitations as a screening test. These include the use of x-ray radiation and uncomfortable compression of an individuals breast. Also, the ability of a mammogram to find breast cancer may depend on the size of the tumor, the density of the breast tissue, and the skill of the radiologist. Mammograms are less likely to find breast tumors in women younger than 50 years than in older women. This may be because younger women have denser breast tissue that appears white on a mammogram resulting in missed cancers or in the discovery of later stage cancers. Light-scattering spectroscopy (LSS) is based on the science of diffusion in which light is scattered from its point of origin and interacts with another medium. When a beam of light comes into contact with an object, the light is absorbed, reflected, and/or scattered. After the light has been scattered, the measurements can be collected and analyzed. Recent advances have allowed for the noninvasive detection of precancerous lesions by using LSS. This approach has been validated for detection of precancerous polyps in the colon and pancreatic cancer.We propose a pilot study to predict the presence of breast cancer through the assessment of the tissue in the nipple using LSS, thereby eliminating the need for any direct examination or radiographic imaging of the inside of the breast. The objective of this study is to evaluate whether LSS can reliably distinguish between two subject groups: those with clinical confirmed stage II or stage III breast cancer and those without breast cancer. If successful, this technology could lead to a safer, less expensive method of breast cancer screening.Patients who agree to take part will have two assessments with the LSS probe done on each breast. They will not be followed after the assessments and their participation will end once the assessments have been completed.The data will be coded, classified, and ranked for each group. These results will be compared to the tumor status of each breast and the number of correct classifications counted. The accuracy of the classifications will be associated with the ability of the device to predict the presence of disease. Optical markers will also be analysed using multivariate analyses. The results will be evaluated and will be used to determine if the device warrants further investigation in this type of cancer.
Recruiting | Breast Cancer | Multisite
Jacques Van Dam, MD, PhD
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SWOG-S1200 A Randomized Blinded Sham- and Waitlist-Controlled Trial of Acupuncture for Joint Symptoms Related to Aromatase Inhibitors in Women with Early Stage Breast Cancer
Background:Despite the well-proven efficacy of Aromatase Inhibitors for the treatment of hormone-sensitive breast cancer, some patients suffer from side effects or even stop treatment early due to undesirable toxicities. The most common side effects of AIs are hot flashes, vaginal dryness, musculoskeletal pain and headache, and possibly alterations in serum lipid profiles. In addition, all third-generation AIs increase bone resorption and may predispose to osteoporosis and fractures.Acupuncture is a popular non-pharmacological modality used for treating a variety of conditions, including musculoskeletal pain. Acupuncture has been shown to have short-term analgesic effect in musculoskeletal pain. Clinical trials have found a benefit to patients with knee osteoarthritis when acupuncture is used as an adjunct to conventional management strategies.Approximately 25% of the population over the age of 55 years is affected by joint pain and about half of them will have some restriction of normal daily activities. Virtually all individuals over the age of 65 have radiographic evidence of osteoarthritis. With conventional approaches such as analgesics and exercise, controlling pain and minimizing loss of function are the principal aims of treatment. About two-thirds of individuals who suffer from joint pain have used complementary and alternative treatments to control their symptoms.Objectives:To determine whether true acupuncture administered twice weekly for 6 weeks (8-12 sessions) compared to sham acupuncture and waitlist control causes a significant reduction in joint pain related to aromatase inhibitors (AIs) in women with early stage breast cancer as measured by the Brief Pain Inventory-Short Form (BPI-SF) worst pain score at 6 weeks.Description of Study Arms:Endpoints:Reduction in worst joint pain at 6 weeks between the true acupuncture compared to sham acupuncture and waitlist control groups: A difference of two points in the modified Brief Pain Inventory worst pain score has been identified as a clinically meaningful difference. This item has a scale of 0 to 10 with 0 indicating No pain and 10 indicating Pain as bad as you can imagine.Investigate the effects of true acupuncture compared to sham acupuncture and waitlist control on several measures compared to baseline.Follow-up:Follow-up visits will be scheduled at six weeks, twelve weeks, twenty-four weeks, and fifty-two weeks.Statistics/Analysis:Patients will be stratified at randomization by study site to account for potential site-specific variation in the administration of acupuncture. The primary endpoint of 6 weeks was chosen in order to confirm initial results of a 6-week acupuncture intervention given twice weekly in a larger multicenter study.A multiple linear regression analysis of the primary endpoint will include the baseline score as well as the pre-specified stratification factor. To allow for an ineligibility of 8% (based on a recent study, S0715), a total of 228 patients will be enrolled to achieve 208 eligible patients.The potential for different dropout by arm, especially with respect to the waitlist control, will be mitigated by monthly conferences among study investigators to encourage proper assessment and submission of forms at every required time-point for all patients. Dropout patterns will be monitored on an ongoing basis.
Active, not recruiting | Breast Cancer | Multisite
Christy Russell
1B-13-10-A Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE) in Patients with Metastatic, GPNMB Over-Expressing, Triple-Negative Breast Cancer. (The METRIC Study)
This study is for females that have been diagnosed with metastatic (i.e., cancer that has spread) triple negative breast cancer (breast cancer that does not have hormone receptors or HER2) and have received no more than one prior chemotherapy treatment for advanced (locally advanced / recurrent or metastatic) breast cancer. CDX-011 (glembatumumab vedotin) is an experimental drug. CDX-011 consists of an antibody attached to a drug, MMAE, that can kill cancer cells, which is intended to work by specifically directing the drug to the cancer cell. The purpose of this study is to see whether CDX-011 is effective in treating research participants who have advanced Triple-Negative Breast Cancer (TNBC; i.e., tumors lacking expression of estrogen, progesterone and HER2 receptors) that contains GPNMB, and to examine the side effects associated with CDX-011 treatment. This study will be conducted at 100 150 centers in the US, Canada and Australia and will include approximately 300 research participants. There are three phases of study procedures, the screening phase (to make sure you are eligible to participate in the study), the treatment phase, and the follow up phase. This is an open-label, prospectively controlled, randomized study. Eligible participants will be randomized 2:1 to receive CDX-011 or capecitabine. CDX-011 will be administered on Day 1 of repeated 21 day cycles. The starting CDX-011 dose is 1.88 mg/kg, given as a 90-minute intravenous infusion. Treatment will continue until progression.Capecitabine will be orally administered on Days 1-14 of repeated 21 day cycles. The recommended capecitabine starting dose is 1250 mg/m2 twice daily. Safety will be assessed by vital sign measurements, clinical laboratory tests, ECGs, physical examinations and the incidence and severity of adverse events.Anti-tumor activity will be assessed via ORR, DOR, PFS and OS. Tumor response and progression will be defined by an independent review committee, according to RECIST 1.1 criteria.Patients will be monitored for the development of anti-CDX-011 and anti-CR011 antibodies, and whether these antibodies are neutralizing.Population PK analyses will be performed to obtain pharmacokinetic parameters and to explore the relationships between patient-specific measures of exposure and safety and activity parameters; the influence of key intrinsic factors, such as weight and gender, on variability in PK will also be evaluated. The impact of circulating GPNMB levels on pharmacokinetic parameters may also be examined.Pharmacodynamics will be evaluated via assessment of tumor tissue obtained via voluntary biopsy or re-resection. The primary efficacy analysis will be performed in accordance with the intention-to-treat principle. All randomized patients will be included in the primary efficacy analysis according to their assigned study treatment, irrespective of the actual treatment received. The primary analysis of safety will include all patients who receive at least 1 dose of study treatment.A futility analysis of ORR will be performed once 90 patients are evaluable for response (either achieve an objective response of PR or CR, discontinue treatment, or complete the 18-week disease assessment).
Recruiting | Breast Cancer | Multisite
Darcy Spicer
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I-SPY 2 Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2)
I-SPY 2 will compare the efficacy of novel drugs in combination with standard chemotherapy with the efficacy of standard therapy alone. The goal is identify improved treatment regimens for subsets on the basis of molecular characteristics (biomarker signatures) of their disease. As described for previous adaptive trials, regimens that show a high Bayesian predictive probability of being more effective than standard therapy will graduate from the trial with their corresponding biomarker signature(s). Regimens will be dropped if they show a low probability of improved efficacy with any biomarker signature. New drugs will enter as those that have undergone testing complete their evaluation.
Recruiting | Breast Cancer | Multisite
Laura Esserman
1B-11-9 Development of an In Vivo Cell Proliferation Marker for PET Assessment of Chemotherapeutic Response in Cancer
Advances in imaging techniques, particularly MRI and CT, have improved the detection and staging of tumors, as well as assessment of therapeutic response in cancer patients. Recent advances suggest that it may be possible to evaluate cell division, one of the most basic processes of tumors, using positron emission tomography (PET). The main objectives of this study are to study [18F]FMAU in 10 patients with known breast cancer to obtain data on safety, circulating metabolite, tumor imaging feasibility, and radiation dosimetry. This will help us to evaluate the potential use of FMAU-PET as an imaging agent for chemotherapeutic response in 15 patients with breast cancer.Patients enrolled for this study will have laboratory confirmed breast cancer. Once participants sign the informed consent and are confirmed to be eligible, they will begin the study. Participants in part 1 will have a one-time [18F] FMAU PET scan before beginning treatment for their cancer. Participants in part 2 will have 3 study visits: before they start cancer therapy, 1 week before their second cycle of chemotherapy, and after completing chemotherapy. The following procedures will be performed during each visit: a physical exam, vital signs, pregnancy test, review of medical history, electrocardiogram (EKG) to assess heart function, and a partial body [18F] FMAU PET scan. All study participants will be followed 24 hours after each PET scan to monitor for any potential side effects.In part 1, a physician will interpret the PET scan to establish baseline values. Part 2 will test the correlation of the PET score at baseline versus PET scores at the later time points outlined above. We will also test the correlation of tumor appearance (i.e. histology) from surgical specimens versus baseline in conjunction with the change of PET score. Statistical analysis will be performed to evaluate tumor response.
Suspended | Breast Cancer | Not Multisite
Peter Conti
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