Status:
COMPLETED
A Study of Epoetin Alfa Plus Standard Supportive Care Versus Standard Supportive Care Only in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Breast Cancer
Neoplasm Metastasis
Eligibility:
FEMALE
18-99 years
Phase:
PHASE3
Brief 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 supportiv...
Detailed Description
Anemia is a common complication of the treatment of metastatic breast cancer and is related to the effects of chemotherapy and to chronic disease itself. This is a randomized, open-label, multicenter,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 2 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2017
Estimated Enrollment :
2098 Patients enrolled
Trial Details
Trial ID
NCT00338286
Start Date
March 2 2006
End Date
January 31 2017
Last Update
March 19 2018
Active Locations (174)
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1
Anaheim, California, United States
2
Gainesville, Florida, United States
3
Miami, Florida, United States
4
New Port Richey, Florida, United States