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Long-term Anastrozole Versus Tamoxifen Treatment Effects (LATTE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01745289
Recruitment Status : Completed
First Posted : December 10, 2012
Last Update Posted : July 10, 2019
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Queen Mary University of London

Tracking Information
First Submitted Date December 5, 2012
First Posted Date December 10, 2012
Last Update Posted Date July 10, 2019
Study Start Date October 2010
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 7, 2012)
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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long-term Anastrozole Versus Tamoxifen Treatment Effects
Official Title Long-term Anastrozole Versus Tamoxifen Treatment Effects (LATTE)
Brief Summary 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
Detailed Description

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
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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 over the age of 18, living in the United States are eligible for LATTE.
Condition Breast Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 8, 2019)
2671
Original Estimated Enrollment
 (submitted: December 7, 2012)
4337
Actual Study Completion Date May 2017
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT01745289
Other Study ID Numbers IRB00050408
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Queen Mary University of London
Study Sponsor Queen Mary University of London
Collaborators American Cancer Society, Inc.
Investigators
Principal Investigator: Robert Smith, PhD American Cancer Society, Inc.
Principal Investigator: Aman Buzdar, MD M.D. Anderson Cancer Center
PRS Account Queen Mary University of London
Verification Date June 2017