A Phase III Clinical Trial of PROCRIT® (Epoetin Alfa) Versus Placebo in Women Undergoing Adjuvant Chemotherapy for Stage I, II or III Breast Cancer

This study has been terminated.

( Study stopped to avoid treating enrolled subjects to hemoglobin levels higher than those specified in current labeling. )

First Received: October 28, 2005 Last Updated: February 12, 2009 History of Changes

Sponsored by:	Ortho Biotech Products, L.P.
Information provided by:	Ortho Biotech Products, L.P.
ClinicalTrials.gov Identifier:	NCT00246597

Purpose

The purpose of this study is to determine whether it is possible to measure temporary difficulty with thinking and/or short-term memory in women who are receiving chemotherapy for early stage breast cancer and to determine whether or not treatment with PROCRIT® will help decrease any problems with thinking or short-term memory that chemotherapy may cause.

Condition	Intervention	Phase
Anemia Breast Neoplasms Hemoglobins Chemotherapy, Adjuvant Quality of Life	Drug: epoetin alfa	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III Clinical Trial of PROCRIT® (Epoetin Alfa) Versus Placebo in Women Undergoing Adjuvant Chemotherapy for Stage I, II or III Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Anemia Breast Cancer Cancer

Drug Information available for: Erythropoietin Epoetin alfa

U.S. FDA Resources

Further study details as provided by Ortho Biotech Products, L.P.:

Primary Outcome Measures:

To assess the effect of PROCRITÂ® on impairment of cognitive and executive function

Estimated Enrollment:	300
Study Start Date:	December 2002
Study Completion Date:	June 2004

Detailed Description:

Studies of the effect of erythropoietin on rat and mouse brain suggests a neuroprotective and cognitive-enhancing effect of this hormone. The objective of this study was to quantify and compare the incidence of chemotherapy-related impairment of cognitive and executive function in breast cancer patients randomized to receive PROCRIT versus placebo while receiving adjuvant anthracycline-based chemotherapy with or without a Taxane and to evaluate the effect of PROCRIT® on the incidence of asthenia (severe fatigue), quality of life (QoL), and mood.

Patients received study medication injections (40,000 units) under their skin once every week for 12 to 24 weeks of chemotherapy. Doses were adjusted depending on the patients' hemoglobin level up to a maximum of 60,000 units.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologic diagnosis of Stage I, II or III cancer (chemotherapy naïve for breast cancer) with anthracycline-based adjuvant chemotherapy with or without a taxane
Hemoglobin >=9 and <=14 g/dL unrelated to transfusion
Able to read, understand and complete QoL & Cognition tools
Patients with reproductive potential must have a negative serum pregnancy test within 7 days of study enrollment and use an adequate contraceptive method

Exclusion Criteria:

Patients who will receive more than a total of 24 weeks of chemotherapy
Psychiatric or neurologic condition that would prevent informed consent and completion of questionnaires or that is poorly controlled with the current treatment regimen
Severe hemiparesis or other condition, distal neuropathy, action tremor or other motor dysfunction, visual deficiencies preventing/decrease bimanual keyboard operation
Severe bradyphrenia (slow thinking) or bradykinesia (slow movement)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00246597

Sponsors and Collaborators

Ortho Biotech Products, L.P.

Investigators

Study Director:

Ortho Biotech Products, L.P. Clinical Trial

Ortho Biotech Products, L.P.

More Information

Additional Information:

A Phase III Clinical Trial of PROCRIT® (Epoetin alfa) versus Placebo in Women Undergoing Adjuvant Chemotherapy for Stage I, II or III Breast Cancer This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CR002305
Study First Received:	October 28, 2005
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00246597 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Ortho Biotech Products, L.P.:

Pure red cell aplasia (PRCA)
Breast cancer
Adjuvant Chemotherapy
Quality of Life

Hemoglobin
Anemia
Cognitive and executive function

Study placed in the following topic categories:

Epoetin Alfa
Red-Cell Aplasia, Pure
Pure Red Cell Aplasia
Skin Diseases
Hematinics
Hematologic Diseases

Adjuvants, Immunologic
Anemia
Quality of Life
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Epoetin Alfa
Neoplasms
Neoplasms by Site
Skin Diseases
Hematinics
Hematologic Diseases

Therapeutic Uses
Hematologic Agents
Anemia
Breast Neoplasms
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on September 10, 2009