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

Inclusion 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 tumorimage in the breast
• Patients must be judged to be candidates for complete resection with free marginsfollowed by radiation therapy (if radiation therapy is indicated)
• For women not undergoing axillary dissection, sentinel node biopsy should document anaxillary nodal burden of 1-2 involved lymph nodes (i.e., ACOSOG Z-11 criteria may beapplied)
• Prior non-invasive (Ductal Carcinoma In Situ) cancer allowed provided there has beenno recurrence
• Prior ipsilateral invasive cancer allowed if more than 5 years previous
• Patients should have at least one organ system involved with distant metastaticdisease
• If patient has only one metastatic lesion/focus, this must be proven by biopsyand the pathology report confirming the diagnosis of primary breast cancer, aswell as the metastatic site, must be available
• Must have available radiologic reports documenting disease status within the past 6weeks 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 menopausalstatus)
• If systemic therapy is discontinued for toxicity, but there is no distantprogression and at least 12 weeks of therapy have been delivered, then thepatient remains eligible
• Radiation therapy (if indicated) must begin within 12 weeks of final therapeuticsurgical procedure (including re-excision for free margins and completion ofaxillary 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 inductionsystemic therapy has been completed
• Patients must be randomized within 16-32 weeks after the start of systemictherapy
• Patients must not have experienced disease progression since the start of systemictherapy, as evidenced by radiographic documentation of disease status before treatmentand 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 therapyare 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 +/- 2weeks 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:

• Synchronous contralateral breast cancer
• Pregnant or nursing