Phase II clinical trial - Sein métastatique triple négatif

Sein métastatique triple négatif
Ouvert depuis le: 09.21.2021
Site: Saint-Cloud
Public cible
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
Description de l'essai

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.