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Phase III Randomized Adjuvant Study of Tamoxifen in Women With Early Breast Cancer
Alternate Title Tamoxifen in Treating Women With Breast Cancer
Objectives
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Patient Characteristics: Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
Expected Enrollment 20000A total of 8,000-20,000 patients will be accrued for this study. Outcomes Primary Outcome(s)All-cause mortality Disease recurrence Outline This is a randomized study. Patients are stratified for analysis according to duration of tamoxifen given before randomization (2-3 years vs 4-5 years vs 6-7 years vs 8-9 years vs 10 years and over), age (less than 49 vs over 50), and important prognostic factors, including tumor type and grade and nodal and estrogen receptor status. Patients are randomized to 1 of 2 treatment arms.
Patients are followed annually. Peer Reviewed and Funded or Endorsed by Cancer Research UK Related PublicationsGray R, Davies C, Perry P: Tamoxifen for early breast cancer: better late than never. Ann Oncol 11 (5): 505-7, 2000.[PUBMED Abstract] Rea D, Poole C, Gray R: Adjuvant tamoxifen: how long before we know how long? BMJ 316 (7143): 1518-9, 1998.[PUBMED Abstract] Earl H, Gray R, Kerr D, et al.: The optimal duration of adjuvant tamoxifen treatment for breast cancer remains uncertain: randomize into aTTom. Clin Oncol (R Coll Radiol) 9 (3): 141-3, 1997.[PUBMED Abstract] Earl H, Baker P, Kerr D, et al.: Adjuvant treatment with tamoxifen. Recruitment into studies assessing optimum duration of treatment must continue. BMJ 312 (7037): 1036-7, 1996.[PUBMED Abstract] Gray R: Tamoxifen: how boldly to go where no women have gone before. J Natl Cancer Inst 85 (17): 1358-60, 1993.[PUBMED Abstract] Trial Lead Organizations Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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