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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
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 cycles and faslodex administered per the package label
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Clinical Benefit Response
Clinical Benefit Response (CBR) defined as Complete Response, Partial Response or Stable Disease for 6 months.
Time frame: 6 months
Progression Free Survival
Determination of progression free survival
Time frame: 6 months
Number of participants with adverse events
Determination of the number of patients who experience adverse events
Time frame: 6 months
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