Clinical trial · Interventional
A Study to Evaluate the Impact of Maintaining Hemoglobin Levels Using Epoetin Alfa in Patients With Metastatic Breast Cancer Receiving Chemotherapy
A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Impact of Maintaining Hemoglobin Using Eprex (Epoetin Alfa) in Metastatic Breast Carcinoma Subjects Receiving Chemotherapy
NCT00211133CI-TRIAL-00004153completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the impact on survival and quality of life of maintaining hemoglobin in the range of 12 to 14 g/dL using epoetin alfa or placebo in patients starting chemotherapy for metastatic breast cancer for the first time.
Conditions
Conditions (3)
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 |
| 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
- 12-month survival rate, defined as the proportion of patients alive at 12 months after the start of the study.
Secondary outcomes (1)
- measure
- Hemoglobin and change in hemoglobin. End of chemotherapy/end of study tumor response. Quality of life. Overall 12-month survival. Red blood cell transfusion rates. Time-to-cancer progression. Overall/median survival times.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients \>= 18 years of age with confirmed diagnosis of metastatic breast cancer who are predicted to start chemotherapy for the first time * Weight \> = 40 kg (88 lbs) * Postmenopausal for at least 1 year, surgically sterile or practicing an effective method of birth control and have a negative serum pregnancy test at the start of the study * Must have signed an informed consent Exclusion Criteria: * Clinically significant lung, heart, hormone, neurological, gastrointestinal, urinary tract or reproductive system disease * Receiving dose intensification chemotherapy for bone marrow or stem cell transplantation * Cancer of the brain or brain/spinal cord disease * Locally advanced or inflammatory breast cancer as the only symptom of breast cancer * Active second primary cancer or documented history of other cancer within the last 3 years * Anemia from a cause other than cancer or radiotherapy/chemotherapy * History of stoke, clots in the lungs or legs or any other blood clotting disorders * Uncontrolled high blood pressure * Untreated folate or Vitamin B12 deficiency * Treatment with epoetin alfa or other forms of erythropoietin within the last 4 weeks * Known hypersensitivity to epoetin alfa or any of its components * Pregnant or breast-feeding
References
Publications (1)
- RESULTLeyland-Jones B, Semiglazov V, Pawlicki M, Pienkowski T, Tjulandin S, Manikhas G, Makhson A, Roth A, Dodwell D, Baselga J, Biakhov M, Valuckas K, Voznyi E, Liu X, Vercammen E. Maintaining normal hemoglobin levels with epoetin alfa in mainly nonanemic patients with metastatic breast cancer receiving first-line chemotherapy: a survival study. J Clin Oncol. 2005 Sep 1;23(25):5960-72. doi: 10.1200/JCO.2005.06.150. Epub 2005 Aug 8. PMID 16087945