Study of AFP464 +/- Faslodex in ER + Breast Cancer

A Randomized Phase II Study of AFP464 +/- Faslodex in ER Positive Breast Cancer Patients Who Had Progressed on Aromatase Inhibitor (AI) Therapy

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.

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,