A Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care Only in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy

• Status: Completed
• Trial end date: 2017-01-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Epoetin Alfa

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.