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 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 (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

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
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:

Synchronous contralateral breast cancer
Pregnant or nursing