Clinical trial NCT00022386: Epoetin Alfa in Treating Chemotherapy-Related Anemia in Women With Stage I, Stage II, or Stage III Breast Cancer
Official title: An Open-Label Study of PROCRIT (Epoetin Alfa) in Women Undergoing Adjuvant Chemotherapy for Stage I, II, or III Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Breast Cancer
Fatigue
Keywords: stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
anemia
fatigue
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-04-05
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: John A. Glaspy, MD, MPH
role: STUDY_CHAIR
References: