An international study designed to answer reliably whether, for women who have hormone sensitive early breast cancer (the most common type of breast cancer), 10 years of adjuvant tamoxifen (a hormone treatment) confers more benefit than just 5 years in terms of reducing the risk of relapse and improving overall, long-term survival: Adjuvant Tamoxifen - Longer Against Shorter (ATLAS)
- Conditions
- Operable, oestrogen receptor positive breast cancer already trated with ~5 years of adjuvant tamoxifenCancerMalignant neoplasm of breast
- Registration Number
- ISRCTN19652633
- Lead Sponsor
- niversity of Oxford (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 15262
Women were eligible for randomisation if:
1. They had had early breast cancer (in which, by definition, all detected disease could be removed surgically)
2. They had subsequently been on adjuvant tamoxifen for several years and were still on it (or had stopped only recently, and could therefore resume treatment without much interruption)
3. They still appeared clinically free of disease (with any local recurrence removed and no distant recurrence ever detected)
4. Long-term follow-up appeared practicable; and, fundamentally,
5. Substantial uncertainty was shared by the woman and her doctor about whether to stop tamoxifen or to continue for several more years, so compliance with random allocation to stop or to continue both seemed likely. There were no restrictions on age, type of initial surgery or histology, hormone receptor status, nodal status or what other treatments had also been given.
Any perceived contraindications to continuing tamoxifen precluded entry. These were specified not by the ATLAS protocol but by the judgment of the responsible clinician. However, the protocol suggested as possible contraindications to tamoxifen continuation (and hence to trial entry):
1. Intended or actual pregnancy or breast feeding
2. Retinopathy
3. Need for coagulation therapy
4. Significant endometrial hyperplasia
5. Any other serious toxicity thought to be due to tamoxifen
6. Negligibly low risk of breast cancer death
7. Presence of another major life-threatening disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Recurrence (loco-regional, contralateral or distant)<br>2. Breast cancer mortality
- Secondary Outcome Measures
Name Time Method 1. Overall mortality<br>2. Various first events before recurrence:<br>2.1. Cancer incidence (particularly uterine, including endometrial)<br>2.2. Hospital admissions for particular reasons (particularly uterine or vascular)<br>2.3. Cause-specific mortality