A Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care Only in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy
Recruiting in Palo Alto (17 mi)
+176 other locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Janssen Research & Development, LLC
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
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
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Treatment Details
Interventions
- Epoetin Alfa (Erythropoiesis-Stimulating Agent)
- Standard Supportive Care (Other)
Participant Groups
2Treatment groups
Experimental Treatment
Group I: 002Experimental Treatment1 Intervention
Standard supportive care (packed RBC transfusion) Per doctor prescription
Group II: 001Experimental Treatment1 Intervention
epoetin alfa + packed RBC transfusion 40 000 IU SC once a week.
Epoetin Alfa is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Epogen for:
- Anemia associated with chronic kidney disease
- Anemia related to HIV infection
- Anemia in patients with cancer on chemotherapy
- Reduction of allogeneic blood transfusions in surgery patients
🇪🇺 Approved in European Union as Eprex for:
- Anemia associated with chronic kidney disease
- Anemia in adult patients with non-myeloid malignancies receiving chemotherapy
- Anemia in HIV-infected patients at risk of transfusion due to chronic disease
🇨🇦 Approved in Canada as Eprex for:
- Anemia associated with chronic kidney disease
- Anemia in patients with cancer on chemotherapy
- Anemia in HIV-infected patients
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NCT00338286Lake Success, NY
NCT00338286Miami, FL
NCT00338286Philadelphia, PA
NCT00338286New Port Richey, FL
More Trial Locations
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Who Is Running the Clinical Trial?
Janssen Research & Development, LLCLead Sponsor