Long-term Anastrozole Versus Tamoxifen Treatment Effects (LATTE)
The LATTE study is an extension study to the now closed Arimidex, Tamoxifen Alone or in combination (ATAC) trail that took place 10 years ago. LATTE aims to collect long term follow-up information since the conclusion of ATAC, and for at least another 5 years, regarding: Additional efficacy data (first local recurrence, first distant recurrence), Additional safety data (ischaemic cardiac and cerebrovascular event, fractures), and Cause specific mortality and new primary cancers.
The LATTE study will pick up where ATAC left off to follow a number of post-menopausal women with breast cancer who were randomised to receive either anastrozole or tamoxifen in the ATAC Trial and not known to have died or withdrawn consent before April 1st 2009. Since ATAC was a nationwide study, the women of LATTE will also reside and receive their follow-up care in various areas of the country. There will not be any vulnerable groups participating in this study.
Patient interaction will consist on in person interviews at designated follow-up times and/or telephone interviews. Data will be collected at point of contact, whether that is in person at the clinic site or over the telephone. Telephone interviews will be completed in LATTE study offices. Topics of focus for data collection consists of: whether or not there is a suspected recurrence, new breast primary tumour, new other primary tumour, ischaemic cardiac event, cerebrovascular event, or a serious fracture. Since the follow-up questions are short in detail, respondent burden time should be less than 1 hour in most cases.
|Study Design:||Observational Model: Other
Time Perspective: Prospective
|Official Title:||Long-term Anastrozole Versus Tamoxifen Treatment Effects (LATTE)|
- 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)
|Study Start Date:||October 2010|
|Study Completion Date:||May 2017|
|Primary Completion Date:||May 2017 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745289
|Principal Investigator:||Robert Smith, PhD||American Cancer Society, Inc.|
|Principal Investigator:||Aman Buzdar, MD||M.D. Anderson Cancer Center|