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

• Status: Terminated
• Trial end date: 2004-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ortho Biotech Products, L.P.
• Treatments: Epoetin Alfa

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)