A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients With Metastatic Breast Cancer
A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients With Metastatic Breast Cancer
RATIONALE: The primary tumor might be a source of re-seeding of distant sites and therefore elimination of this source of metastasizing cells by early local therapy may be of benefit.
PURPOSE: This randomized phase III trial is studying early surgery to see how well it works compared to standard palliative therapy in treating patients with stage IV breast cancer.
OBJECTIVES:
Primary
Secondary
Exploratory
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 in 1:1 ratio.
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.
Inclusion Criteria:
Diagnosis of intact primary (not recurrent) invasive carcinoma of 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 (Ductal Carcinoma In Situ) cancer allowed provided there has been no recurrence
Prior ipsilateral invasive cancer allowed if more than 5 years previous
Patients should have at least one organ system involved with distant metastatic disease
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)
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 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:
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
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
Negative pregnancy test
Fertile patients must use an accepted and effective contraception method
Exclusion criteria:
Long Beach, California 90806, United States
Monterey, California 93940, United States
Hartford, Connecticut 06105, United States
Daytona Beach, Florida 32114, United States
Orlando, Florida 32803-1273, United States
Tampa, Florida 33612-9497, United States
Atlanta, Georgia 30303, United States
Savannah, Georgia 31405, United States
Boise, Idaho 83706, United States
Boise, Idaho 83712, United States
Chicago, Illinois 60611-3013, United States
Libertyville, Illinois 60048, United States
Maywood, Illinois 60153, United States
Moline, Illinois 61265, United States
Ottawa, Illinois 61350, United States
Peoria, Illinois 61615, United States
Beech Grove, Indiana 46107, United States
Indianapolis, Indiana 46202-5289, United States
La Porte, Indiana 46350, United States
Des Moines, Iowa 50309, United States
Des Moines, Iowa 50314, United States
Wichita, Kansas 67214, United States
Lexington, Kentucky 40536-0093, United States
Baltimore, Maryland 21231-2410, United States
Dearborn, Michigan 48123-2500, United States
Grosse Pointe Woods, Michigan 48236, United States
Southfield, Michigan 48075, United States
Minneapolis, Minnesota 55407, United States
Robbinsdale, Minnesota 55422-2900, United States
Lebanon, New Hampshire 03756-0002, United States
Manchester, New Hampshire 03102, United States
Flemington, New Jersey 08822, United States
Marlton, New Jersey 08053, United States
Toms River, New Jersey 08755, United States
Voorhees Township, New Jersey 08043, United States
Voorhees Township, New Jersey 08043, United States
Cooperstown, New York 13326, United States
Poughkeepsie, New York 12601-3990, United States
Rochester, New York 14642, United States
Staten Island, New York 10305, United States
White Plains, New York 10601, United States
Charlotte, North Carolina 28232-2861, United States
Winston-Salem, North Carolina 27157-1096, United States
Hershey, Pennsylvania 17033-0850, United States
Meadowbrook, Pennsylvania 19046, United States
Philadelphia, Pennsylvania 19107-5541, United States
Williamsport, Pennsylvania 17701, United States
Charleston, South Carolina 29425, United States
Spartanburg, South Carolina 29303, United States
Sioux Falls, South Dakota 57117-5039, United States
Jackson, Tennessee 38301, United States
Seattle, Washington 98122-4307, United States
Seattle, Washington 98195, United States
Walla Walla, Washington 99362, United States
Huntington, West Virginia 25702, United States
Eau Claire, Wisconsin 54701, United States
Green Bay, Wisconsin 54301-3526, United States
Green Bay, Wisconsin 54311, United States
Madison, Wisconsin 53792-6164, United States
Manitowoc, Wisconsin 54221-1450, United States
Summit, Wisconsin 53066, United States
Wausau, Wisconsin 54401, United States