Adjuvant Tamoxifen Treatment - offer more? To assess reliably the balance of benefits and risks of prolonging adjuvant tamoxifen treatment by 5 years for women with breast cancer
Not Applicable
Completed
- Conditions
- Breast cancerCancerMalignant neoplasm of breast
- Registration Number
- ISRCTN17222211
- Lead Sponsor
- The University of Birmingham (UK)
- Brief Summary
2019 results in https://pubmed.ncbi.nlm.nih.gov/31504126/ (added 23/10/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 6953
Inclusion Criteria
1. Any woman who has had complete excision of breast carcinoma
2. Any primary treatment
3. At least 2 years of prior adjuvant tamoxifen treatment (5 recommended)
4. Clinically relapse free
5. No definite indications or contraindications for further tamoxifen treatment: uncertainty as to whether further tamoxifen treatment will be of benefit
6. Where possible, ER status should be known prior to randomisation
Exclusion Criteria
Not provided at time of registration
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To detect or refute reliably any overall survival benefit from extending the duration of therapy with adjuvant tamoxifen
- Secondary Outcome Measures
Name Time Method ot provided at time of registration