A Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care Only in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy
Breast Cancer, Neoplasm Metastasis
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring anemia, metastatic breast cancer, Hemoglobin, progression-free survival (PFS), erythropoiesis-stimulating agents (ESA)
Eligibility Criteria
Inclusion Criteria: Histologically confirmed (e.g., slide of tissue) breast cancer HER2/NEU positive or negative Clinical evidence of metastasis (e.g., biopsy) with at least 1 measurable metastatic (M1) lesion prior to starting the current chemotherapy Received 1st and 2nd line chemotherapy Hemoglobin (Hb) <= 11g/dL at the time of randomization planned to receive at least 2 more cycles of chemotherapy Life expectancy > 6 months Eastern Cooperative Oncology Group score 0 or 1 At least 18 years old using effective birth control or surgically sterile or postmenopausal for 1 year Exclusion Criteria: Active second cancer no recent history of clinically relevant thrombovascular event Current treatment with anticoagulants Brain metastasis or CNS involvement Anemia secondary to another cause Recent (within prior 1 months) use of an ESA Patient pregnant or breast feeding Progressive disease during adjuvant/neoadjuvant chemotherapy Rapidly progressive or life-threatening metastatic disease Concomitant endocrine therapy Patient in whom the only site of metastasis was local and was successfully treated surgically.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Other
001
002
epoetin alfa + packed RBC transfusion 40 000 IU SC once a week.
Standard supportive care (packed RBC transfusion) Per doctor prescription