Status:
COMPLETED
A Study to Evaluate the Impact of Maintaining Hemoglobin Levels Using Epoetin Alfa in Patients With Metastatic Breast Cancer Receiving Chemotherapy
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Anemia
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
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 chemother...
Detailed Description
Cancer patients often experience anemia due to the disease itself, chemotherapy or both. Quality of life is also affected, due in part to the fatigue associated with anemia. Previous studies with epoe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
939 Patients enrolled
Trial Details
Trial ID
NCT00211133
Start Date
June 1 2000
End Date
December 1 2006
Last Update
November 30 2010
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.