A Study to Evaluate the Impact of Maintaining Hemoglobin Levels Using Epoetin Alfa in Patients With Metastatic Breast Cancer Receiving Chemotherapy

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: 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 3
• Accepts Healthy Volunteers?: No

Details

• 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