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An Open-Label Study of PROCRIT (Epoetin Alfa) in Women Undergoing Adjuvant Chemotherapy for Stage I, II, or III Breast Cancer

Phase 4
18 Years
Not Enrolling
Anemia, Breast Cancer, Fatigue

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Trial Information

An Open-Label Study of PROCRIT (Epoetin Alfa) in Women Undergoing Adjuvant Chemotherapy for Stage I, II, or III Breast Cancer

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.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage I, II, or III
breast cancer Planned adjuvant anthracycline-based chemotherapy with or without a taxane
for 3-6 months Hemoglobin 10-14 g/dL (independent of transfusion) No anemia due to factors
other than cancer/chemotherapy (i.e., iron, cyanocobalamin, or folate deficiency;
hemolysis; gastrointestinal bleeding; or myelodysplastic syndrome) Hormone receptor
status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified
Performance status: ECOG 0-2 Life expectancy: At least 9 months Hematopoietic: See Disease
Characteristics Hepatic: Not specified Renal: Not specified Cardiovascular: No
uncontrolled or severe cardiovascular disease No myocardial infarction within the past 6
months No uncontrolled hypertension No congestive heart failure Other: No hypersensitivity
to mammalian cell-derived products No hypersensitivity to human albumin Not pregnant or
nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 months since prior epoetin alfa or
any investigational forms of erythropoietin (e.g., gene-activated erythropoietin or novel
erythropoiesis- stimulating protein) No transfusion within the past 30 days No other
concurrent epoetin alfa Chemotherapy: See Disease Characteristics Endocrine therapy: Not
specified Radiotherapy: Not specified Surgery: Not specified Other: No other concurrent
investigational drugs No other concurrent treatments for anemia

Type of Study:


Study Design:

Primary Purpose: Supportive Care

Principal Investigator

John A. Glaspy, MD, MPH

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Anemia
  • Breast Cancer
  • Fatigue
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • anemia
  • fatigue
  • Anemia
  • Breast Neoplasms
  • Fatigue