Study of AFP464 +/- Faslodex in ER + Breast Cancer
- Registration Number
- NCT01233947
- Lead Sponsor
- Tigris Pharmaceuticals
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 7
Inclusion Criteria
- proven breast cancer, ER+ status; progression on an aromatase inhibitor; measurable disease or evaluable disease with serum CA27.29>=50 U/mL; adequate bone marrow, liver and renal function; DLco grade 0 or 1.
Exclusion Criteria
- HER2 positive, thoracic radiotherapy or symptomatic pulmonary disease, brain metastases,
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AFP464 AFP464 74 mg/m2 AFP464 administered as a 3 hour IV infusion on Days 1 and 8 of a 21-day cycle. AFP464 + Faslodex 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.
- Primary Outcome Measures
Name Time Method Clinical Benefit Response 6 months Clinical Benefit Response (CBR) defined as Complete Response, Partial Response or Stable Disease for 6 months.
- Secondary Outcome Measures
Name Time Method Progression Free Survival 6 months Determination of progression free survival
Number of participants with adverse events 6 months Determination of the number of patients who experience adverse events
Trial Locations
- Locations (1)
Texas Oncology-Baylor Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States