Early Surgery or Standard Palliative Therapy in Treating Patients with Stage IV Breast Cancer

Inclusion Criteria

• Patients must have an intact primary (not recurrent) invasive carcinoma of the breast; biopsy confirmation of the primary tumor should be by needle biopsy (preferred); incisional surgical biopsy is allowed as long as there is residual palpable or imageable tumor in the breast
• Patients with synchronous contralateral invasive breast cancer are excluded
• Patients should have at least one organ system involved with distant metastatic disease; if only a single metastatic lesion is present, biopsy is mandatory
• Baseline studies must be performed 8 weeks prior to the start of systemic therapy, and must document the extent of disease in the breast; the specifics of this are at physician discretion, but must address clinical signs and symptoms; if pre-therapy scans were not performed, scans performed within the first 4 weeks of systemic therapy, but prior to registration, will be accepted; radiology reports documenting status of disease must be available
• If palliative radiation to non-breast sites is required prior to initiation of systemic therapy, scans may be completed within 8 weeks prior to or 4 weeks following the start of radiation therapy
• 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
• Patients may have had prior non-invasive (ductal carcinoma in situ [DCIS]) cancer if there has been no recurrence; prior ipsilateral invasive cancer also allowed if more than 5 years previous
• Patients with a history of other primary cancers are eligible if the pathology report confirming the diagnosis of primary breast cancer is available and the other primary cancer was curatively treated with a 5-year disease-free interval * Patients with non-melanoma skin cancer are eligible; however, patients with squamous cell carcinoma of other sites (except in-situ cervix) are not eligible
• Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception
• Patients with central nervous system (CNS) metastases are eligible (as long as projected survival is > 6 months)
• Patients who require radiotherapy to distant metastases during induction systemic therapy are eligible
• Date of randomization must be within 32 weeks of initiation of optimal systemic therapy
• 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) * NOTE: The patient will be considered eligible if the last day of the treatment cycle meets the 16 weeks criteria * If systemic therapy is discontinued for toxicity, there is no distant progression and at least 12 weeks of therapy have been delivered, then the patient remains eligible; if systemic therapy is changed for reasons other than progression of disease (e.g. from chemotherapy to endocrine therapy), the patient remains eligible
• Documentation regarding the details of administration of all systemic chemotherapy must be available
• Patients must not have experienced distant disease progression since the start of systemic therapy, as evidenced by clinical and radiographic documentation of disease status before treatment and within 6 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 * Imaging at step 2 should preferably be the same as at step 1 (baseline); it must address all previous sites of disease and all clinical signs and symptoms; if all step 1 imaging tests cannot be repeated, the reason should be documented (e.g. declined by insurance); step 2 imaging must evaluate all known sites of disease and address all signs/symptoms present at step 2
• Patients must be judged to be candidates for complete resection with free margins followed by radiation therapy (if radiation therapy is indicated)
• Local disease at the primary site must be asymptomatic
• Patients must have adequate organ function to undergo local therapy 4 weeks +/ - 2 weeks prior to randomization per investigator discretion and institutional guidelines
• Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy