Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer (NCT01242800) | Clinical Trial Compass
CompletedNot Applicable
Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer
United States390 participantsStarted 2011-05-16
Plain-language 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 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.
Who can participate
Age range18 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
3-year Overall Survival Rate
Timeframe: Assessed at baseline, then every 3 months within 2 years and every 6 months between 2-5 years, up to 5 years