None listed
Conditions
Brief summary
At present, it is standard for women with early breast cancer to receive five years of treatment with tamoxifen, following surgery. For many women, tamoxifen reduces the risk of breast cancer returning. However, some information suggests that tamoxifen may be of most benefit in the two to three years after surgery, after which it becomes less effective. The Adjuvant Exemestane trial will test whether it is better to take five years of tamoxifen, or to begin a new treatment (exemestane) after two to three years of tamoxifen, for the remainder of the five years. Exemestane is effective in patients with advanced cancer who have already been treated with tamoxifen and had their cancer return. Internationally, 4400 postmenopausal women who have had early breast cancer and taken two to three years of tamoxifen treatment will take part in the trial, and be given either exemestane or more tamoxifen to finish five years of treatment. It is hoped that switching treatments will be more effective at lowering the risk of breast cancer returning than continuing tamoxifen, and it may also lower the risk of developing long-term side effects from tamoxifen.
Interventions
This study is designed to compare the following treatment arms:
* Exemestane 25mg/day orally for 2-3 years
* Tamoxifen 20mg/day orally for 2-3 years.
Treatment on study is given following 2-3 years of treatment with tamoxifen. The overall duration of endocrine treatment is 5 years.
Sponsors
Pharmacia and Upjohn (now merged as part of Pfizer)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
At breast cancer diagnosis, patients must have: histologically or cytologically confirmed unilateral adenocarcinoma of the breast which was considered "operable". ER status positive or unknown. Have had adequate therapy for primary disease. At randomisation patients must: Be postmenopausal as defined by: any patient > or equal to 55 and ammenorrhoea for > 2 years or, radiation menopause (at least 3 months previously) or surgical oophorectomy or, natural amenorrhoea > or equal to 1 year at breast cancer diagnosis. At randomisation, patients must be receiving tamoxifen and have been treated with tamoxifen for between 2 and 3 years (dose = 20mg/d, unless otherwise agreed with Pharmacia and Upjohn before joining the study) with no more than one month break at any time.Remain free from disease following treatment for primary disease. Have adequate haematological, renal and hepatic function. Be accessible for follow-up for the duration of the trial. Have given written informed consent.
Exclusion criteria
No longer available - study closed to recruitment in 2003.
Outcome results
None listed