Breast CancerLATTENCT01745289
Long-term Anastrozole Versus Tamoxifen Treatment Effects
An observational study of Breast Cancer, run by Queen Mary University of London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 2,671 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2010to May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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cancer who were randomised to receive either anastrozole or tamoxifen in the ATAC Trial and not known to have died or withdrawn consent before April 1st 2009 over the age of 18, living in the United States are eligible for LATTE.
Who may be able to join
- patients randomised to one of the monotherapy arms in the ATAC Trial
- alive at 10 years follow-up
Who cannot join
- patients who have withdrawn consent to participate in the ATAC Trial or this study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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Mary University of London
London, England, EC1M6BQ
About this study
Official title: 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
Read the 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.
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Survival, Recurrence
- Medical subject headings
- Breast Neoplasms, Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: LATTE particpants who are 10 years post treatment will be followed for 5 years for the purpose of this study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startOct 2010
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,671 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Robert Smith, PhD, Principal investigator, American Cancer Society, Inc.Aman Buzdar, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745289
- Sponsor's protocol ID
- IRB00050408
- Acronym
- LATTE
- Status last verified
- Jun 2017
- First submitted
- 5 Dec 2012
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21087898Allawi 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.
PubMed 21765042
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Anastrozole Versus Tamoxifen Treatment Effects (LATTE)
- ClinicalTrials.gov ID
- NCT01745289
- Acronym / sponsor ID
- LATTE / IRB00050408
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Survival, Recurrence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,671 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Oct 2010
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 10 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- patients randomised to one of the monotherapy arms in the ATAC Trial
- alive at 10 years follow-up
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Background: PubMed 21087898Cuzick 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.
- Background: PubMed 21765042Allawi 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.
- Long-term comparison of anastrozole versus tamoxifen: Results from LATTE/ATACLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Smith, PhD principal investigator
American Cancer Society, Inc.
Aman Buzdar, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01745289, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.