Clinical trial · Interventional
A Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care Only in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy
A Randomized, Open-label, Multicenter, Phase 3 Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy
- 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 assess the impact on tumor progression as evaluated by progression-free survival (PFS) of epoetin alfa plus standard supportive care as compared with standard supportive care alone (packed red blood cell (RBC) transfusions), for treating anemia according to label guidance in patients with metastatic breast cancer receiving standard chemotherapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| epoetin alfa + packed RBC transfusion | Drug | — | UNRESOLVED |
| Standard supportive care (packed RBC transfusion) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 001
- description
- epoetin alfa + packed RBC transfusion 40 000 IU SC once a week.
- interventionNames
- Drug: epoetin alfa + packed RBC transfusion
- type
- OTHER
- label
- 002
- description
- Standard supportive care (packed RBC transfusion) Per doctor prescription
- interventionNames
- Other: Standard supportive care (packed RBC transfusion)
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- From the date of randomization to the date of disease progression (PD) or death, whichever occurred first (up to 8.4 years)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed (e.g., slide of tissue) breast cancer * HER2/NEU positive or negative * Clinical evidence of metastasis (e.g., biopsy) with at least 1 measurable metastatic (M1) lesion prior to starting the current chemotherapy * Received 1st and 2nd line chemotherapy * Hemoglobin (Hb) \<= 11g/dL at the time of randomization * planned to receive at least 2 more cycles of chemotherapy * Life expectancy \> 6 months * Eastern Cooperative Oncology Group score 0 or 1 * At least 18 years old using effective birth control or surgically sterile or postmenopausal for 1 year Exclusion Criteria: * Active second cancer * no recent history of clinically relevant thrombovascular event * Current treatment with anticoagulants * Brain metastasis or CNS involvement * Anemia secondary to another cause * Recent (within prior 1 months) use of an ESA * Patient pregnant or breast feeding * Progressive disease during adjuvant/neoadjuvant chemotherapy * Rapidly progressive or life-threatening metastatic disease * Concomitant endocrine therapy * Patient in whom the only site of metastasis was local and was successfully treated surgically.
References
Publications (1)
- DERIVEDLeyland-Jones B, Bondarenko I, Nemsadze G, Smirnov V, Litvin I, Kokhreidze I, Abshilava L, Janjalia M, Li R, Lakshmaiah KC, Samkharadze B, Tarasova O, Mohapatra RK, Sparyk Y, Polenkov S, Vladimirov V, Xiu L, Zhu E, Kimelblatt B, Deprince K, Safonov I, Bowers P, Vercammen E. A Randomized, Open-Label, Multicenter, Phase III Study of Epoetin Alfa Versus Best Standard of Care in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy. J Clin Oncol. 2016 Apr 10;34(11):1197-207. doi: 10.1200/JCO.2015.63.5649. Epub 2016 Feb 8. PMID 26858335