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

Status: Recruiting
Diagnosis: Breast: Metastatic
NCT ID: NCT01242800 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-064


RATIONALE: Early surgery may have fewer side effects and improve recovery. Palliative surgery or radiation therapy may help patients with advanced breast cancer live more comfortably. It is not yet known whether early surgery is more effective than palliative therapy for advanced breast cancer. PURPOSE: This randomized phase III trial is studying early surgery to see how well it works compared to standard palliative therapy in treating patients with stage IV breast cancer.


Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Mehra Golshan, MD, Brigham and Women's Hospital

Site-responsible Investigators:

Dana-Farber Cancer Institute: Breast Cancer Nursing Team, 617-632-3478

Eligibility 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
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