Long-term Anastrozole Versus Tamoxifen Treatment Effects (LATTE)
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|ClinicalTrials.gov Identifier: NCT01745289|
Recruitment Status : Completed
First Posted : December 10, 2012
Last Update Posted : July 10, 2019
|Condition or disease|
The LATTE study aims to collect further follow-up information on a maximum of 2200 UK eligible patients, who were randomised to the monotherapy arms (anastrozole or tamoxifen) in the ATAC trial. The LATTE study also aims to collect follow-up information on as many eligible patients as possible in international sites in the EU, US and Australia/New Zealand who were randomised to the monotherapy arms (anastrozole or tamoxifen) in the ATAC trial. The study's primary objective is to provide additional efficacy and safety data on time to recurrence of breast cancer and death after recurrence. The secondary objectives include time to distant recurrence, cancer-specific survival, new breast primaries, other cancers, ischaemic cardiac and cerebrovascular events and hip (and other) fractures. Participants will be followed-up annually until at least 15 years median follow-up.
In 2010, results from 10-year follow-up from ATAC demonstrated that there is long-term superiority of anastrozole over tamoxifen as initial adjuvant therapy for post-menopausal women with hormone-sensitive early breast cancer. This paper demonstrated that there were significantly lower rates of local and distant recurrence, as well as reduced contralateral breast cancer in patients treated with anastrozole. However, in 2016 a recent preliminary analysis of the LATTE study demonstrated that the benefits of anastrozole do not continue long-term after 10 years in terms of reduced recurrence rates. The results also suggested that there was a larger reduction of new contralateral tumours with tamoxifen. However, the preliminary analysis was limited in that there was limited data with possible under reporting of vital events inked to the safety and efficacy endpoints; this therefore may diminish the effect of anastrozole. Queen Mary University of London (QMUL) therefore require extended cohort events, obtainable from HES, cancer registration and mortality data in order to conclude the long-term safety of either intervention. QMUL will then be able to integrate the pseudonymised LATTE data with the ATAC data sets in order to perform an analysis of the overall 20-year follow-up period.
|Study Type :||Observational|
|Actual Enrollment :||2671 participants|
|Official Title:||Long-term Anastrozole Versus Tamoxifen Treatment Effects (LATTE)|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||May 2017|
- Time to recurrence [ Time Frame: LATTE particpants who are 10 years post treatment will be followed for 5 years for the purpose of this study. ]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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01745289
|Queen Mary University of London|
|London, England, United Kingdom, EC1M6BQ|
|Principal Investigator:||Robert Smith, PhD||American Cancer Society, Inc.|
|Principal Investigator:||Aman Buzdar, MD||M.D. Anderson Cancer Center|