Status:
COMPLETED
Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer
Lead Sponsor:
Eastern Cooperative Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Stage IV Breast Cancer
Eligibility:
All Genders
18-120 years
Phase:
NA
Brief Summary
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 r...
Detailed Description
OBJECTIVES: Primary * To evaluate whether early local therapy of intact primary disease in patients with Stage IV breast cancer whose disease does not progress during initial optimal systemic therap...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 16 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2022
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT01242800
Start Date
May 16 2011
End Date
December 21 2022
Last Update
June 29 2023
Active Locations (377)
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1
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States, 36604
2
Providence Cancer Center
Anchorage, Alaska, United States, 99508
3
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
4
East Bay Radiation Oncology Center
Castro Valley, California, United States, 94546