None listed
Conditions
Brief summary
Trials of adjuvant tamoxifen in women with early breast cancer have demonstrated a highly significant improvement in 10-year survival. However it is not yet known how long women with early breast cancer should continue to take adjuvant tamoxifen. The ATLAS trial will determine if it is better to stop taking tamoxifen after 5 years, or continue taking it for another 5 years (10 years in total).
Interventions
Patients enter the trial after completing approximately 5 years of tamoxifen for early breast cancer and are randomised to either continue tamoxifen for a further 5 years or stop tamoxifen. The dosage of tamoxifen is recommended at 20mg.day orally unless the patient's clinician prefers a different dosage. Patients will continue to be followed for at least 5 years after completing treatment.
Sponsors
Breast Cancer Trials
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Women who have received any type of curative surgery for early breast cancer are eligible (irrespective of the original histological type of the disease, nodal status, or whether the tumour was estrogen receptor positive or negative) so long as the woman appears currently to be free of breast cancer and is receiving tamoxifen and where both the woman and her doctor are uncertain whether to continue with tamoxifen.
Exclusion criteria
No exclusion criteria
Outcome results
None listed