Spots Global Cancer Trial Database for Study on Androgen Receptor and Triple Negative Breast Cancer
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Trial Identification
Brief Title: Study on Androgen Receptor and Triple Negative Breast Cancer
Official Title: A Randomized Phase 2 Study in Patients With Triple-negative Androgen Receptor Positive Locally Recurrent (Unresectable) or Metastatic Breast Cancer Treated With Darolutamide or Capecitabine
Study ID: NCT03383679
Study Description
Brief Summary: This is a multicenter uncontrolled, open-label, prospective, non-comparative randomized, phase II study. Patients will be randomized between darolutamide in Arm n°1 (two-stage Simon's design) and capecitabine in Arm n°2 with two patients randomized in Arm n°1 for one patient randomized in Arm n°2. The trial population is composed of women over 18 years old with triple-negative and androgen receptor positive, locally recurrent (unresectable) or metastatic breast cancer.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Centre François Baclesse, Caen, , France
Contact Details
Name: Hervé BONNEFOI, MD
Affiliation: Institut Bergonié - University of Bordeaux 2
Role: STUDY_CHAIR
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