Breast Cancer Clinical Trial
— LATTEOfficial title:
Long-term Anastrozole Versus Tamoxifen Treatment Effects (LATTE)
NCT number | NCT01745289 |
Other study ID # | IRB00050408 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2010 |
Est. completion date | May 2017 |
Verified date | June 2017 |
Source | Queen Mary University of London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Established in 2010, the Long-term Anastrozole vs Tamoxifen Treatment Effects (LATTE) observational study aims to collect vital long-term safety and efficacy data on anastrozole and tamoxifen, drugs that were taken by post-menopausal women as part of the Anastrozole Tamoxifen Alone or in Combination (ATAC) trial. ATAC was a crucial breast cancer trial evaluating the use of aromatase inhibitors (AIs) in the adjuvant setting, with a median follow-up of over 10 years. The ATAC trial assessed the safety and efficacy of anastrozole+placebo, tamoxifen+placebo and anastrozole+tamoxifen in postmenopausal women undergoing treatment for invasive primary breast cancer
Status | Completed |
Enrollment | 2671 |
Est. completion date | May 2017 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - patients randomised to one of the monotherapy arms in the ATAC Trial - alive at 10 years follow-up Exclusion Criteria: - patients who have withdrawn consent to participate in the ATAC Trial or this study - where the LATTE Executive Committee determines that there is no possibility of obtaining follow-up |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Queen Mary University of London | London | England |
Lead Sponsor | Collaborator |
---|---|
Queen Mary University of London | American Cancer Society, Inc. |
United Kingdom,
Allawi Z, Cuzick J, Baum M; ATAC/LATTE investigators. Does trauma or an intercurrent surgical intervention lead to a short-term increase in breast cancer recurrence rates? Ann Oncol. 2012 Apr;23(4):866-9. doi: 10.1093/annonc/mdr316. Epub 2011 Jul 15. — View Citation
Cuzick J, Sestak I, Baum M, Buzdar A, Howell A, Dowsett M, Forbes JF; ATAC/LATTE investigators. Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: 10-year analysis of the ATAC trial. Lancet Oncol. 2010 Dec;11(12):1135-41. doi: 10.1016/S1470-2045(10)70257-6. Epub 2010 Nov 17. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to recurrence | Time to recurrence of breast cancer in the post 10 year period (defined as the earliest of local or distant recurrence, new primary breast cancer, or death) | LATTE particpants who are 10 years post treatment will be followed for 5 years for the purpose of this study. |
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