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