Epoetin Alfa in Treating Chemotherapy-Related Anemia in Women With Stage I, Stage II, or Stage III Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00022386
Recruitment Status : Completed
First Posted : April 5, 2004
Last Update Posted : July 18, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Anemia Breast Cancer Fatigue Biological: epoetin alfa Procedure: quality-of-life assessment Phase 4

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 Type : Interventional  (Clinical Trial)
Primary Purpose: Supportive Care
Official Title: An Open-Label Study of PROCRIT (Epoetin Alfa) in Women Undergoing Adjuvant Chemotherapy for Stage I, II, or III Breast Cancer
Actual Study Completion Date : April 2004

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00022386

Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: John A. Glaspy, MD, MPH Jonsson Comprehensive Cancer Center Identifier: NCT00022386     History of Changes
Other Study ID Numbers: ORTHO-PR-00-27-012
CDR0000068811 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: April 5, 2004    Key Record Dates
Last Update Posted: July 18, 2013
Last Verified: May 2002

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Hematologic Diseases
Signs and Symptoms
Epoetin Alfa