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


Phase 3
18 Years
N/A
Not Enrolling
Female
Anemia, Breast Neoplasms, Hemoglobins, Quality of Life, Chemotherapy, Adjuvant

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Trial 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


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.


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Ortho Biotech Products, L.P. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Ortho Biotech Products, L.P.

Authority:

United States: Institutional Review Board

Study ID:

CR002305

NCT ID:

NCT00246597

Start Date:

December 2002

Completion Date:

June 2004

Related Keywords:

  • Anemia
  • Breast Neoplasms
  • Hemoglobins
  • Quality of Life
  • Chemotherapy, Adjuvant
  • Anemia
  • Breast cancer
  • Hemoglobin
  • Quality of Life
  • Adjuvant Chemotherapy
  • Pure red cell aplasia (PRCA)
  • Cognitive and executive function
  • Anemia
  • Breast Neoplasms
  • Neoplasms

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