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
is noted.
Interventional
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.
6 months
No
Joanne L. Blume, M.D.
Principal Investigator
Texas Oncology-Baylor Charles A. Sammons Cancer Center
United States: Food and Drug Administration
TG-AFP-003
NCT01233947
May 2011
August 2012
Name | Location |
---|---|
Texas Oncology-Baylor Charles A. Sammons Cancer Center | Dallas, Texas 75246 |