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

Completed · Not applicable

Conditions studied: Breast Cancer, Stage IV Breast Cancer

In brief

RATIONALE: The primary tumor might be a source of re-seeding of distant sites and therefore elimination of this source of metastasizing cells by early local therapy may be of benefit. 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.

Key facts

Study ID

NCT01242800

Run by

Eastern Cooperative Oncology Group

People needed

390

Starts

2011-05-16

Expected to finish

2022-12-21

Last updated by the study team

2023-06-29

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Synchronous contralateral breast cancer
• Pregnant or nursing

Where it is running

• Providence Cancer Center — Anchorage, Alaska, United States
• Mayo Clinic Scottsdale — Scottsdale, Arizona, United States
• East Bay Radiation Oncology Center — Castro Valley, California, United States
• Enloe Cancer Center at Enloe Medical Center — Chico, California, United States
• North Bay Cancer Center — Fairfield, California, United States
• California Cancer Care, Incorporated - Greenbrae — Greenbrae, California, United States
• Todd Cancer Institute at Long Beach Memorial Medical Center — Long Beach, California, United States
• Contra Costa Regional Medical Center — Martinez, California, United States
• Community Hospital of the Monterey Peninsula Comprehensive Cancer Center — Monterey, California, United States
• El Camino Hospital Cancer Center — Mountain View, California, United States
• CCOP - Bay Area Tumor Institute — Oakland, California, United States
• St. Joseph Hospital Regional Cancer Center - Orange — Orange, California, United States
• Doctors Medical Center - San Pablo Campus — San Pablo, California, United States
• Stanford Cancer Center — Stanford, California, United States
• Boulder Community Hospital — Boulder, Colorado, United States
• Penrose Cancer Center at Penrose Hospital — Colorado Springs, Colorado, United States
• Presbyterian - St. Luke's Medical Center — Denver, Colorado, United States
• Exempla Lutheran Medical Center — Wheat Ridge, Colorado, United States
• Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center — Hartford, Connecticut, United States
• Norwalk Hospital — Norwalk, Connecticut, United States
• Eastern Connecticut Hematology and Oncology Associates — Norwich, Connecticut, United States
• Tunnell Cancer Center at Beebe Medical Center — Lewes, Delaware, United States
• CCOP - Christiana Care Health Services — Newark, Delaware, United States
• Herbert D. Kerman Regional Oncology Center - Daytona Beach — Daytona Beach, Florida, United States
• University of South Alabama Mitchell Cancer Institute — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.