A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients With Metastatic Breast Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- 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 (DCIS) cancer allowed provided there has been no recurrence

- Prior ipsilateral invasive cancer allowed if more than 5 years previous

- No synchronous contralateral breast cancer

- 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

PATIENT CHARACTERISTICS:

- See Disease Characteristics

- 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

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use an accepted and effective contraception method

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics