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SCCA Breast Cancer Clinical Trials

Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer (CTSU E2108)
A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer
Status Conditions Phase Study ID
Closed to recruitment. Breast Cancer III CTSU E2108
NCT01242800
Summary
To evaluate whether early local therapy of intact primary disease in women with Stage IV breast cancer whose disease does not progress during initial optimal systemic therapy, will result in prolonged survival, compared to women who receive local therapy for palliation only.
Investigator
Fred Appelbaum. MD
Location    
SCCA Breast Cancer Clinical Trials Program 800-804-8824 Refer Patient
Eligibility Criteria (must meet the following to participate in this study)
  • Patients (male or female) must have an intact primary (not recurrent) invasive carcinoma of the breast. Biopsy confirmation of the primary tumor should be by needle biopsy (preferred); incisional surgical biopsy is allowed as long as there is residual palpable or imageable tumor in the breast.
  • Patients should have at least one site of distant metastatic disease. If only a single metastatic lesion is present, biopsy is mandatory. See Section 3.1.6.
  • Radiology reports documenting status of disease prior to initiation of systemic therapy must be available. Scans must have been completed within 4 weeks prior to start of systemic therapy.
  • If patient has only one site of metastatic disease, 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.
  • Single metastatic lesion? ______ (Yes/No) Biopsy? ______ (Yes/No)
  • Patients may have had prior non-invasive (DCIS) cancer if there has been no recurrence.
  • Patients with a history of other primary cancers are eligible if the pathology report confirming the diagnosis of primary breast cancer is available and the other primary cancer was curatively treated with a 5-year disease-free interval.
  • Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception.
  • Patients with CNS metastases are eligible (as long as projected survival is > 6 months).
Exclusions (conditions that would prevent participation in this study)
  • Patients with synchronous contralateral breast cancer are excluded.
Last Updated
October 08, 2012
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.