A Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care Only in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy
Condition: Breast Cancer; Neoplasm Metastasis
MeSH terms: Breast Neoplasms; Neoplasm Metastasis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the impact on tumor progression as evaluated by
      progression-free survival (PFS) of epoetin alfa plus standard supportive care as compared
      with standard supportive care alone (packed red blood cell (RBC) transfusions), for treating
      anemia according to label guidance in patients with metastatic breast cancer receiving
      standard chemotherapy.
    

Detailed description: 
      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.
    

Intervention name(s): Standard supportive care (packed RBC transfusion); epoetin alfa + packed RBC transfusion
Intervention type(s): Other; Drug
Intervention description(s): Per doctor prescription; 40,000 IU SC once a week.
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anemia; metastatic breast cancer; Hemoglobin; progression-free survival (PFS); erythropoiesis-stimulating agents (ESA)