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A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients With Metastatic Breast Cancer

Description

Detailed Description
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.

Phase

N/A

Inclusion and Exclusion Criteria

  • Diagnosis of intact primary (not recurrent) invasive carcinoma of the breast
  • Stage IV disease
  • Confirmation of the primary tumor should be by needle biopsy (preferred)
  • Incisional surgical biopsy allowed as long as there is residual palpable or tumor image in the breast
  • Patients must be judged to be candidates for complete resection with free margins followed by radiation therapy (if radiation therapy is indicated)
  • For women not undergoing axillary dissection, sentinel node biopsy should document an axillary nodal burden of 1-2 involved lymph nodes (i.e., ACOSOG Z-11 criteria may be applied)
  • Prior non-invasive (DCIS) cancer allowed provided there has been no recurrence
  • Prior ipsilateral invasive cancer allowed if more than 5 years previous
  • No synchronous contralateral breast cancer
  • Patients should have at least one organ system involved with distant metastatic disease
  • If patient has only one metastatic lesion/focus, this must be proven by biopsy and the pathology report confirming the diagnosis of primary breast cancer, as well as the metastatic site, must be available
  • Must have available radiologic reports documenting disease status within the past 6 weeks prior to initiating systemic therapy
  • CNS metastases allowed provided projected survival > 6 months
  • Patients must have completed at least 16 weeks of optimal systemic therapy (appropriate to the tumor biological profile and the patient's age and menopausal status)
  • If systemic therapy is discontinued for toxicity, but there is no distant progression and at least 12 weeks of therapy have been delivered, then the patient remains eligible
  • Radiation therapy (if indicated) must begin within 12 weeks of final therapeutic surgical procedure (including re-excision for free margins and completion of axillary dissection)
  • Patients may register at any time from the time of diagnosis of stage IV breast cancer (if eligibility criteria met) to the time when a maximum of 30 weeks of induction systemic therapy has been completed
  • Patients must be randomized within 16-32 weeks after the start of systemic therapy
  • Patients must not have experienced disease progression since the start of systemic therapy, as evidenced by radiographic documentation of disease status before treatment and within 4 weeks +/
  • 2 weeks prior to randomization, including:
  • No new sites of disease
  • No enlargement of existing sites by 20% or more in longest diameter
  • No symptomatic deterioration
  • Patients who require radiotherapy to bone metastases during induction systemic therapy are eligible
  • Local disease at the primary site must be asymptomatic
  • Hormone receptor status known PATIENT CHARACTERISTICS:
  • See Disease Characteristics
  • Menopausal status not specified
  • Patients must have adequate organ function to undergo local therapy 4 weeks +/
  • 2 weeks prior to randomization per investigator discretion and institutional guidelines
  • More than 5 years since other primary cancers that were curatively treated
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use an accepted and effective contraception method PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics

Sites

  • California

    • Todd Cancer Institute at Long Beach Memorial Medical Center, Long Beach, California, 90806
    • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange, California, 92868
    • St. Joseph Hospital Regional Cancer Center - Orange, Orange, California, 92868
    • Enloe Cancer Center at Enloe Medical Center, Chico, California, 95926

  • New Mexico

    • Lovelace Medical Center - Downtown, Albuquerque, New Mexico, 87102
    • University of New Mexico Cancer Center - South, Las Cruces, New Mexico, 88011

  • Colorado

    • North Suburban Medical Center, Thornton, Colorado, 80229

  • Washington

    • Harrison Medical Center, Bremerton, Washington, 98310

  • Oklahoma

    • Oklahoma University Cancer Institute, Oklahoma City, Oklahoma, 73104

  • Texas

    • Doctor's Hospital of Laredo, Laredo, Texas, 78045
    • Baylor Medical Center at Irving, Irving, Texas, 75061
    • Methodist Hospital, Houston, Texas, 77030

  • North Dakota

    • Medcenter One Hospital Cancer Care Center, Bismarck, North Dakota, 58501
    • Trinity CancerCare Center, Minot, North Dakota, 58701

  • Missouri

    • St. Anthony's Cancer Center, Saint Louis, Missouri, 63128

  • Illinois

    • Trinity Cancer Center at Trinity Medical Center - 7th Street Campus, Moline, Illinois, 61265
    • Provena St. Mary's Regional Cancer Center - Kankakee, Kankakee, Illinois, 60901
    • Hinsdale Hematology Oncology Associates, Hinsdale, Illinois, 60521
    • North Shore Oncology and Hematology Associates, Limited - Libertyville, Libertyville, Illinois, 60048
    • Cancer Care and Hematology Specialists of Chicagoland - Niles, Niles, Illinois, 60714
    • Kellogg Cancer Care Center, Highland Park, Illinois, 60035
    • Hematology Oncology Associates - Skokie, Skokie, Illinois, 60076

  • Wisconsin

    • Center for Cancer Treatment & Prevention at Sacred Heart Hospital, Eau Claire, Wisconsin, 54701
    • Marshfield Clinic Cancer Care at Regional Cancer Center, Eau Claire, Wisconsin, 54701
    • Marshfield Clinic - Indianhead Center, Rice Lake, Wisconsin, 54868
    • Marshfield Clinic - Chippewa Center, Chippewa Falls, Wisconsin, 54729
    • Saint Joseph's Hospital, Marshfield, Wisconsin, 54449
    • Marshfield Clinic - Wisconsin Rapids Center, Wisconsin Rapids, Wisconsin, 54494
    • Saint Michael's Hospital Cancer Center, Stevens Point, Wisconsin, 54481
    • Marshfield Clinic at Saint Michael's Hospital, Stevens Point, Wisconsin, 54481
    • Marshfield Clinic - Wausau Center, Wausau, Wisconsin, 54401
    • Diagnostic and Treatment Center, Weston, Wisconsin, 54476
    • Marshfield Clinic - Weston Center, Weston, Wisconsin, 54476
    • UW Cancer Center Johnson Creek, Johnson Creek, Wisconsin, 53038
    • Marshfield Clinic - Lakeland Center, Minocqua, Wisconsin, 54548
    • Ministry Medical Group at Saint Mary's Hospital, Rhinelander, Wisconsin, 54501
    • Theda Care Cancer Institute, Appleton, Wisconsin, 54911
    • Fox Valley Surgical Associates at Appleton Medical Center, Appleton, Wisconsin, 54911

  • Mississippi

    • University of Mississippi Cancer Clinic, Jackson, Mississippi, 39216

  • Tennessee

    • West Tennessee Cancer Center at Jackson-Madison County General Hospital, Jackson, Tennessee, 38301

  • Alabama

    • University of South Alabama Mitchell Cancer Institute, Mobile, Alabama, 36604

  • Indiana

    • Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana, 46350
    • William N. Wishard Memorial Hospital, Indianapolis, Indiana, 46202
    • Howard Community Hospital, Kokomo, Indiana, 46904
    • CCOP - Northern Indiana CR Consortium, South Bend, Indiana, 46601
    • Elkhart General Hospital, Elkhart, Indiana, 46515

  • Michigan

    • Lakeside Cancer Specialists, PLLC, Saint Joseph, Michigan, 49085
    • Lakeland Regional Cancer Care Center - St. Joseph, Saint Joseph, Michigan, 49085
    • Foote Memorial Hospital, Jackson, Michigan, 49201
    • MidMichigan Medical Center - Midland, Midland, Michigan, 48670

  • Kentucky

    • St. Elizabeth Medical Center, Edgewood, Kentucky, 41017

  • Georgia

    • John B. Amos Cancer Center, Columbus, Georgia, 31904
    • Kennestone Cancer Center at Wellstar Kennestone Hospital, Marietta, Georgia, 30060
    • Piedmont Hospital, Atlanta, Georgia, 30309
    • Georgia Cancer Center for Excellence at Grady Memorial Hospital, Atlanta, Georgia, 30303
    • Emory Crawford Long Hospital, Atlanta, Georgia, 30308
    • Charles B. Eberhart Cancer Center at DeKalb Medical Center, Decatur, Georgia, 30033
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