A Randomized Phase II Study of AFP464 +/- Faslodex in ER Positive Breast Cancer Patients Who Had Progressed on Aromatase Inhibitor (AI) Therapy
This is a randomized, open-label study. Patients will be randomized in a 1:1 ratio to
single arm AFP464, or AFP464+Faslodex. Patients will be treated until disease progression
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical Benefit Response
Clinical Benefit Response (CBR) defined as Complete Response, Partial Response or Stable Disease for 6 months.
Joanne L. Blume, M.D.
Texas Oncology-Baylor Charles A. Sammons Cancer Center
United States: Food and Drug Administration
|Texas Oncology-Baylor Charles A. Sammons Cancer Center||Dallas, Texas 75246|