Overview

Tamoxifen Study

Status:
Completed
Trial end date:
1995-11-01
Target enrollment:
0
Participant gender:
Female
Summary
To assess the impact of tamoxifen on development of breast cancer, coronary heart disease, and bone fractures. The National Cancer Institute initiated the prevention trial under its National Surgical Adjuvant Breast and Bowel Project (NSABP). The National Heart, Lung, and Blood Institute provided support to obtain blood pressure and lipid measurements, and lipoprotein and selected coagulation factor measurements in a subsample.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
NSABP Foundation Inc
Collaborator:
National Cancer Institute (NCI)
Treatments:
Tamoxifen
Criteria
Women over the age of 35 with a 5-year predicted breast cancer risk of at least 1.66
percent or a history of lobular breast carcinoma in situ, life expectancy of 10 years or
more, breast examination and mammogram without evidence of cancer, no hormonal therapy
within three months prior to randomization, and no history of deep venous thrombosis or
pulmonary embolism. .