5092S-11: CTSU E2108 breast

CTSU E2108: A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary

Type of Study
Cancer (Oncology) - Breast
Swedish Cancer Institute
Short Description

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.



Open to Enrollment
Principal Investigator
Christine Lee, M.D.
Eligibility Notes
  • 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
  • Prior non-invasive (DCIS) cancer allowed provided there has been no recurrence
  • Must be judged to be candidates for complete resection with free margins followed by radiation therapy (if radiation therapy is indicated)
  • No synchronous contralateral breast cancer
  • At least one organ system involved with distant metastatic disesae
  • Patients must have completed 16 weeks of optimal systemic therapy 
  • Local disease at the primary site must be asymptomatic
  • Hormone receptor status known
More Info Link
Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
(206) 215-3086