Phase 3
Completed N=2,098
A Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care Only in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy
Breast Cancer · Neoplasm Metastasis
Source: ClinicalTrials.gov NCT00338286 ↗
Enrolled (actual)
2,098
Serious AEs
22.9%
Results posted
Mar 2016
Primary outcomePrimary: Progression Free Survival — 7.4; 7.4 Months
◆ Published Evidence
Established
70citations · ~7 / year
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.
Summary
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.
Linked Publications
-
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival |
7.4; 7.4 | — |
| SECONDARY Overall Survival |
18.0; 17.8 | — |
| SECONDARY Time to Tumor Progression |
7.5; 7.5 | — |
| SECONDARY Overall Response Rate (ORR) |
3; 3; 48; 47; 30; 32 | — |
| SECONDARY Percentage of Participants With Suspected Thrombotic Vascular Events (TVEs) |
3.72; 4.86 | — |
Eligibility Criteria
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) 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.
Data sourced from ClinicalTrials.gov (NCT00338286) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.