Overview
A Study to Evaluate the Impact of Maintaining Hemoglobin Levels Using Epoetin Alfa in Patients With Metastatic Breast Cancer Receiving Chemotherapy
Status:
Completed
Completed
Trial end date:
2006-12-01
2006-12-01
Target enrollment:
0
0
Participant gender:
Female
Female
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 chemotherapy for metastatic breast cancer for the first time.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Treatments:
Epoetin Alfa
Criteria
Inclusion Criteria:- 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 Criteria:
- 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