Status:
TERMINATED
Study of AFP464 +/- Faslodex in ER + Breast Cancer
Lead Sponsor:
Tigris Pharmaceuticals
Conditions:
Breast Neoplasm
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- HER2 positive, thoracic radiotherapy or symptomatic pulmonary disease, brain metastases,
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01233947
Start Date
May 1 2011
End Date
August 1 2012
Last Update
January 9 2012
Active Locations (1)
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1
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246