Study of AFP464 +/- Faslodex in ER + Breast Cancer
AFP464 is an investigational agent which may be effective in the treatment of cancer. The purpose of this study is to test the efficacy of AFP464 +/- Faslodex in ER+ breast cancer patients.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Study of AFP464 +/- Faslodex in ER Positive Breast Cancer Patients Who Had Progressed on Aromatase Inhibitor (AI) Therapy|
- Clinical Benefit Response [ Time Frame: 6 months ] [ Designated as safety issue: No ]Clinical Benefit Response (CBR) defined as Complete Response, Partial Response or Stable Disease for 6 months.
- Progression Free Survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]Determination of progression free survival
- Number of participants with adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Determination of the number of patients who experience adverse events
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||August 2012|
|Estimated Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
74 mg/m2 AFP464 administered as a 3 hour IV infusion on Days 1 and 8 of a 21-day cycle.
AFP464 administered as a 3-hour IV infusion on Days 1 and 8 of a 21-day cycle
Other Name: (aminoflavone)
Experimental: AFP464 + Faslodex
AFP464 administered as a 3 hour IV infusion on Days 1 and 8 of a 21-day cycles and Faslodex administered per package label.
Drug: AFP464 + Faslodex
AFP464 administered as a 3-hour IV infusion on Days 1 and 8 of a 21-day cycles and faslodex administered per the package label
Other Name: (aminoflavone) + (Fulvestrant)
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.
|United States, Texas|
|Texas Oncology-Baylor Charles A. Sammons Cancer Center|
|Dallas, Texas, United States, 75246|
|Principal Investigator:||Joanne L. Blume, M.D.||Texas Oncology-Baylor Charles A. Sammons Cancer Center|