Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal

Status Completed

Clinical Trial Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using either tamoxifen or anastrozole may fight breast cancer by blocking the use of estrogen. It is not yet known whether tamoxifen is more effective than anastrozole in preventing breast cancer after surgery for ductal carcinoma in situ. PURPOSE: This randomized phase III trial is studying how well adjuvant tamoxifen works compared to anastrozole in treating postmenopausal women who have undergone surgery to remove ductal carcinoma in situ.

Clinical Trial Description

OBJECTIVES: Primary - Compare the efficacy of adjuvant tamoxifen vs anastrozole, in terms of local control and prevention of contralateral disease, in postmenopausal women with locally excised ductal carcinoma in situ. - Compare side effect profiles of these drugs in these patients. Secondary - Compare the efficacy of these drugs, according to the receptor status of the primary or recurrent cancer in these patients. - Compare the rate of breast cancer recurrence and growth of new contralateral tumors after cessation of treatment with these drugs in these patients. - Compare breast cancer mortality in patients treated with these drugs. - Compare the effect of these drugs on other cancers, cardiovascular disease, fracture rates, and non-breast cancer deaths in these patients. - Compare the tolerability and acceptability of side effects experienced by patients treated with these drugs. OUTLINE: This is a randomized, double-blind, multicentre study. Patients are stratified according to participating centre. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral tamoxifen and oral placebo once daily. - Arm II: Patients receive oral anastrozole and oral placebo once daily. In both arms, treatment continues for 5 years in the absence of disease recurrence or unacceptable toxicity. Patients are followed annually for 5 years and a further 5 years (minimum) off treatment. Peer Reviewed and Funded by Cancer Research UK. Sponsored by Queen Mary University of London ACTUAL ACCRUAL: A total of 2,980 patients were accrued for this study over 9 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00072462
Study type	Interventional
Source	Queen Mary University of London
Contact
Status	Completed
Phase	Phase 3
Start date	September 2003
Completion date	May 31, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ — IBIS-II DCIS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms