Clinical trial · Interventional
A Phase III Clinical Trial of PROCRIT (Epoetin Alfa) Versus Placebo in Women Undergoing Adjuvant Chemotherapy for Stage I, II or III Breast Cancer
NCT00246597CI-TRIAL-00004879terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study stopped to avoid treating enrolled subjects to hemoglobin levels higher than those specified in current labeling.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Chemotherapy, Adjuvant | — | UNRESOLVED | — |
| Hemoglobins | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| epoetin alfa | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To assess the effect of PROCRIT® on impairment of cognitive and executive function
Secondary outcomes (1)
- measure
- To assess the effect of PROCRIT® on severe fatigue, quality of life and mood. Hemoglobin (Hg) Responders were those patients who did not require transfusion during the treatment phase and who demonstrated a > or = 2 g/dL increase in Hg or Hg of 12 g/dL.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.