Trial Information

A Randomized, Open-label, Multicenter, Phase 3 Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy

Anemia is a common complication of the treatment of metastatic breast cancer and is related
to the effects of chemotherapy and to chronic disease itself. This is a randomized,
open-label, multicenter, international study to further examine the safety of the study drug
used with standard supportive care (i.e., packed RBC transfusions) compared to standard
supportive care alone, when used to treat anemia associated with chemotherapy. This study
will be done in subjects with metastatic breast cancer who are being or will be treated with
first-line chemotherapy with standard dose schedules of taxane monotherapy, or a taxane plus
trastuzumab, or an anthracycline plus either a taxane or cyclophosphamide. The study
hypothesis is that epoetin alfa, when used as supportive anemia care, does not increase the
risk of tumor progression or death. The study treatment will be compared to the control
treatment by comparing progression-free survival, i.e., the number of months from the date a
patient is randomized into the trial to the date of the first documented disease progression
or death. In addition to their chemotherapy, half of the subjects will be assigned to
receive study drug (epoetin alfa) and half of the subjects will be assigned to standard
supportive care for anemia. Subjects treated with the study drug will receive standard
supportive care (packed RBC transfusions) plus 40,000 IU epoetin alfa given subcutaneously
once a week until 4 weeks after the last cycle of chemotherapy or until disease progression,
whichever comes first.The hypothesis is to test that epoetin alfa, when used as supportive
anemia care, is non-inferior to control (standard supportive care alone), as measured by
progression free survival (PFS). Patients treated with the study drug will receive standard
supportive care (packed red blood cells (RBC) transfusions) plus 40,000 IU epoetin alfa
given subcutaneously once a week until 4 weeks after the last cycle of chemotherapy or until
disease progression, whichever comes first. Dose adjustments (dose escalation, dose
reduction, dose interruption, and dose resumption) of epoetin alfa will be based on
hemoglobin (Hb) and confirm to prescribing information.