An Open-Label Study of PROCRIT (Epoetin Alfa) in Women Undergoing Adjuvant Chemotherapy for Stage I, II, or III Breast Cancer
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
Study Overview
Brief Summary
RATIONALE: Epoetin alfa may stimulate red blood cell production to treat patients who have anemia following chemotherapy.
PURPOSE: Phase IV trial to study the effectiveness of epoetin alfa in treating chemotherapy-related anemia in women who have stage I, stage II, or stage III breast cancer.
Detailed Description
OBJECTIVES: I. Determine the effectiveness and safety of epoetin alfa in patients receiving adjuvant chemotherapy for stage I, II, or III breast cancer. II. Determine the clinical outcomes in these patients receiving this drug.
OUTLINE: This is a multicenter study. Patients receive epoetin alfa subcutaneously once weekly for up to 24 weeks in the absence of unacceptable toxicity. Quality of life is assessed at baseline, at week 13, and at study completion.
PROJECTED ACCRUAL: A maximum of 2,500 patients will be accrued for this study.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Supportive Care
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided