23 studies found

Nutritional Preferences and Product Accessibility in Oral Nutritional Supplements in Participants With Breast, Colorectal, Upper Gastrointestinal, or Prostate Cancer

PRIMARY OBJECTIVES: I. Identify how patients with cancer are obtaining nutrition to support medical management. SECONDARY OBJECTIVES: I. Examine associations of gastrointestinal side effects with specific diagnoses and respective medical therapies. II. Understand how patients access information regarding nutritional supplements. III. Evaluate patient satisfaction with currently available oral nutritional supplements...

I-SPY 2 TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

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...

Standard of Care Therapy With or Without Stereotactic Radiosurgery and/or Surgery in Treating Patients With Limited Metastatic Breast Cancer

PRIMARY OBJECTIVES: I. To determine whether ablation (through stereotactic body radiation therapy [SBRT] [stereotactic radiosurgery] and/or surgical resection of all known metastases) in oligometastatic breast cancer patients provides a sufficient signal for improved progression-free survival (PFS) to warrant full accrual to the Phase III portion of the trial. (Phase II-R)...

A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer

This study will evaluate the efficacy of ipatasertib + paclitaxel versus placebo + paclitaxel in participants with histologically confirmed, locally advanced or metastatic triple-negative breast cancer (TNBC) and in participants with locally advanced or metastatic hormone receptor positive (HR+)/ human epidermal growth factor receptor 2 negative (HER2−) breast adenocarcinoma who...

Core Biopsies for Establishing a Breast Tumor Tissue Repository

PRIMARY OBJECTIVES: I. To develop a baseline and serial breast cancer core biopsy repository within the University of Southern California (USC)/Norris Comprehensive Cancer Center Women's Cancer Program. II. To develop and maintain a secure clinical database of relevant demographic, clinical, pathologic and longitudinal outcome characteristics of the samples to be...

Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer

This is an international, multicenter, randomized, open-label, active-controlled, event-driven, Phase 3 clinical study comparing the efficacy and safety of elacestrant to the SoC options of fulvestrant or an aromatase inhibitor (AI) in postmenopausal women and in men with advanced or metastatic ER+/HER2- breast cancer, either in subjects with tumors that...

Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors

- Dose Escalation Stage: to determine the schedule and maximum tolerated dose (MTD) and/or recommended Expansion Stage dose of cabozantinib when taken in combination with a standard dosing regimen of atezolizumab (1200 mg infusion, once every 3 weeks). - Expansion Stage: to determine the preliminary efficacy (objective response rate [ORR]...

Controlled Low Calorie Diet in Reducing Side Effects and Increasing Response to Chemotherapy in Patients With Breast or Prostate Cancer

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...

A Phase 1/2 Safety Study of Intratumorally Dosed INT230-6

INT230-6 is comprised of a 3 agents in a fixed ratio - a cell permeation enhancer and two, potent anti-cancer payloads (cisplatin and vinblastine sulfate). The penetration enhancer facilitates dispersion of the two drugs throughout injected tumors and enables increased diffusion into cancer cells. (Nonclinical safety studies showed no findings...

Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer

PRIMARY OBJECTIVES: I. To compare the proportions of participants in the tomosynthesis mammography (TM) and digital mammography (DM) study arms experiencing the occurrence of an ?advanced? breast cancer at any time during a period of 4.5 years from randomization, including the period of active screening and a period of clinical...

S1501 Carvedilol in Preventing Cardiac Toxicity in Patients With Metastatic HER-2-Positive Breast Cancer

PRIMARY OBJECTIVES: I. To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of subsequent cardiac dysfunction in patients with metastatic breast cancer receiving trastuzumab?based HER-2 targeted therapy. SECONDARY OBJECTIVES: I. To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention...

Combined Breast MRI and Biomarker Strategies in Identifying High-risk Breast Cancer Patients

PRIMARY OBJECTIVES: I. To determine the number of high risk women with abnormal screening breast MRI and morphologically normal biopsy over 7 years. SECONDARY OBJECTIVES: I. To determine if WNT10B/mutant p53 expression as measured in the 0-month biopsy predicts women with an abnormal MRI/non-cancerous biopsy who will progress to cancer...

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutation With Advanced Breast Cancer Who Have Progressed on or After Prior Treatments

Study assessing the efficacy and safety of alpelisib plus fulvestrant or letrozole, based on prior endocrine therapy, in patients with PIK3CA mutation with advanced breast cancer who have progressed on or after prior treatments

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Using Light-Scattering Spectroscopy to detect advanced stage breast cancer

The purpose of this study is to determine the safety and effectiveness of an investigational device for the detection of breast cancer. The device is an optical probe that uses a technique called light scattering spectroscopy (LSS). LSS uses visible light reflected from the breast to provide information about the...

Neratinib +/- Fulvestrant in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer

This phase II study will test cancer to see if it has a HER2 mutation and, if so, see how HER2 mutated cancer responds to treatment with neratinib.

Serum Tumor Marker Directed Disease Monitoring in Patients With Hormone Receptor Positive Her2 Negative Metastatic Breast Cancer

PRIMARY OBJECTIVES: I. To assess whether patients with HER-2 negative, hormone receptor positive, metastatic breast cancer who are monitored with serum tumor marker directed disease monitoring (STMDDM) have non-inferior overall survival compared to patients monitored with usual care. SECONDARY OBJECTIVES: I. To compare cumulative direct healthcare costs through 48 weeks...

Trial to Compare Radiation Fibrosis With Five Versus Three Fractions

Partial breast irradiation (PBI) is becoming a new paradigm for breast cancer radiation. No type I or II evidence is currently available to demonstrate equivalence to standard whole breast radiotherapy, and a prospective randomized trial jointly sponsored by NSABP and Radiation therapy Oncology Group (RTOG) (NSABP B-39 and RTOG 0413)...

Contrast Enhanced Spectral Mammography With Digital Breast Tomosynthesis For Patients With Newly Diagnosed Breast Cancer

PRIMARY OBJECTIVES: I. To compare the index lesion size (the largest diameter) from each of the four readings (standard of care 2 dimensional [D], magnetic resonance imaging [MRI], contrast enhanced spectral mammography [CESM], 3D) to gold standard index lesion size from surgical pathology (the largest diameter). II. To document the...

Hypofractionated Radiation Therapy After Mastectomy in Preventing Recurrence in Patients With Stage IIa-IIIa Breast Cancer

PRIMARY OBJECTIVES: I. To evaluate whether the reconstruction complication rate at 24 months post radiation is non-inferior with hypofractionation. SECONDARY OBJECTIVES: I. To evaluate the incidence of acute and late radiation complications, based on Common Terminology Criteria for Adverse Events (CTCAE) 4.0 toxicity. II. To evaluate the local and local...

Pembrolizumab in Treating Patients With Triple-Negative Breast Cancer

PRIMARY OBJECTIVE: I. To compare invasive disease-free survival (IDFS) of patients with triple-negative (TNBC) or low estrogen receptor (ER)-positive and/or HER2 borderline breast cancer who have >= 1 cm residual invasive breast cancer and/or positive lymph nodes (ypN1mi, ypN1, ypN2, ypN3) after neoadjuvant chemotherapy randomized to receive 1 year of...

Standard or Comprehensive Radiation Therapy in Treating Patients With Early-Stage Breast Cancer Previously Treated With Chemotherapy and Surgery

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...

Nivolumab and Ipilimumab in Treating Patients With Rare Tumors

PRIMARY OBJECTIVES: I. To evaluate the Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 overall response rate (ORR) in subsets of patients with advanced rare cancers treated with ipilimumab plus nivolumab combination immunotherapy. II. To evaluate the overall response rate (ORR) in patients with gestational trophoblastic tumors treated with...

Trial of Strategies to Communicate Genetic Information to Different Ethnic Subpopulations

Any patient referred to the breast cancer and genetic risk counseling clinics in either of the two sites will be eligible to participate as long as they meet the inclusion and exclusion criteria. The research assistant in each site will meet with the patients and explain about the study goals...