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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
- Open at Saint-Cloud since : 10/04/2018
- Target : Adult
- Phase : Phase II
Trial description
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.
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