Long-term Anastrozole Versus Tamoxifen Treatment Effects (LATTE)

July 8, 2019 updated by: Queen Mary University of London

Long-term Anastrozole Versus Tamoxifen Treatment Effects (LATTE)

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

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

2671

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • London, England, United Kingdom, EC1M6BQ
        • Queen Mary University of London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
LATTE particpants who are 10 years post treatment will be followed for 5 years for the purpose of this study.

Collaborators and Investigators

This is where you will find people and organizations involved with this 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

December 5, 2012

First Submitted That Met QC Criteria

December 7, 2012

First Posted (Estimate)

December 10, 2012

Study Record Updates

Last Update Posted (Actual)

July 10, 2019

Last Update Submitted That Met QC Criteria

July 8, 2019

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00050408

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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