LATTE: Long-term Anastrozole versus Tamoxifen Treatment Effects
| ISRCTN | ISRCTN86305500 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86305500 |
| IRAS number | 339492 |
| ClinicalTrials.gov number | NCT01745289 |
| Secondary identifying numbers | IRAS 339492 |
- Submission date
- 19/03/2009
- Registration date
- 30/03/2009
- Last edited
- 24/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Breast cancer is increasingly becoming a “survivable” disease, and an increasing number of recurrences occur late, so that there is much interest about the long-term efficacy and safety of treatments. The Oxford Overview process has provided useful data on follow-up for 15-20 years after tamoxifen therapy. Such data are lacking for the newer aromatase inhibitors (AIs). This study provides a unique opportunity to address this issue. The ‘Arimidex, Tamoxifen, Alone or in Combination’ (ATAC) trial is the vanguard breast cancer trial for the use of AIs in the adjuvant setting, with a median follow-up of 100 months. With the LATTE Study, it is proposed to collect further follow-up information on the 4,300 patients randomised to mono-therapy (anastrozole or tamoxifen).This research will aim to provide additional efficacy (including local and distant recurrence, and new contralateral tumours) data, and information on survival, new primary cancers at other sites, and other major ischaemic cardiac and cerebrovascular events.
Who can participate?
Women who took part in the ATAC trial in 1996 - 2003.
What does the study involve?
Study involves collecting long-term follow-up data for patients from the ATAC study (monotherapy arm) on an annual basis. This includes data from routine clinic visits based on local practice, via GP information request and where appropriate, by post or telephone.
What are the possible benefits and risks of participating?
There are no direct benefits for patients who took part in the ATAC trial, but the data collected through the LATTE study will contribute to better understanding of the effects of both anastrozole and tamoxifen in terms of efficacy and safety in the long term which may benefit patients in the future. There are no risks associated with taking part in the study.
Where is the study run from?
45 centres in the UK, five in Australia, one in New Zealand, one in Belgium, two in Canada, four in Italy, six in the US, six in France, four in the Netherlands, one is South Africa, 11 in Sweden and three in Germany.
When is the study starting and how long is it expected to run for?
April 2009 to February 2026. Active data collection from participating hospitals was ongoing until January 2019. After 2019, further long-term follow-up data will be obtained for UK participants only from national registries in the UK (such as NHS Digital), unless the participant withdraws consent to this. All participating hospitals in the UK and other countries have been closed since 2019.
Who is funding the study?
AstraZeneca
Who is the main contact?
Professor Jack Cuzick
j.cuzick@qmul.ac.uk
Contact information
Scientific
Centre for Cancer Prevention
Queen Mary University of London
Wolfson Institute of Preventive Medicine
Charterhouse Square
London
EC1M 6BQ
United Kingdom
 ORCID ID |
0000-0001-7420-7512 |
|---|---|
| Phone | +44 (0)20 7882 3504 |
| j.cuzick@qmul.ac.uk |
Scientific
Project Manager/Data Manager
Barts CTU
Centre for Evaluation and Methods
Wolfson Institute of Population Health
Faculty of Medicine and Dentistry
Queen Mary University of London
London
E1 4NS
United Kingdom
| j.zahedi@qmul.ac.uk |
Study information
| Study design | International multicentre epidemiological observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Long-term Anastrozole versus Tamoxifen Treatment Effects in breast cancer: an epidemiologial observational study |
| Study acronym | LATTE |
| Study objectives | The aim of this study is to provide additional efficacy (including local and distant recurrence, and new contralateral tumours) data, and information on survival, new primary cancers at other sites, and other major ischaemic cardiac and cerebrovascular events. |
| Ethics approval(s) |
1. Approved 19/01/2009, London – South East (formerly South East Research Ethics Committee) (Health Research Authority, 2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8222, (0)207 104 8177, (0)207 104 8263; londonsoutheast.rec@hra.nhs.uk), ref: 09/H1102/1 2. Approved 15/02/2024, London - South East Research Ethics Committee (Health Research Authority 2, Redman Place, London, E20 1JQ, United Kingdom; +44 (0)207 104 8222, (0)207 104 8177, (0)207 104 8263; londonsoutheast.rec@hra.nhs.uk), ref: 24/LO/0102 |
| Health condition(s) or problem(s) studied | Breast cancer |
| Intervention | Current interventions as of 09/04/2024: There are no trial drugs or treatments associated with this observational study. Long-term follow-up data will be collected for this Research Database for the following outcomes: Recurrence of breast cancer: Patients should be reviewed for recurrence of breast cancer at all follow-up visits. The site and date of confirmed first loco-regional and first distant recurrence will be recorded in the follow-up case report form (CRF). After loco-regional and distant recurrence patients will be followed for survival, new primary cancers and subsequent recurrences only. New breast primaries (either contralateral or ipsilateral) will be regarded as disease recurrence events in the statistical analyses of time to recurrence. Death: All patients will be followed for survival. Patients will be registered with national digital registries in the UK for longer-term outcome data including death and other outcome data. New breast primaries: New breast primaries (either contralateral or ipsilateral), confirmed by histology or cytology, and with no other confirmed recurrence, will be recorded as a new breast primary. Additional information will be requested in order to determine whether the New Breast Primary is invasive or DCIS and whether it is oestrogen-receptor positive. Other cancers: New primary cancers confirmed by histology or cytology, or other diagnostic procedure. Ischaemic cardiac and cerebrovascular events, hip (and other) fractures: Serious cardiac or cerebrovascular events (such as myocardial infarct or stroke; not angina or transient ischaemic attack), all hip fractures, and fractures leading to an overnight stay in hospital. Note: From 2019 onwards, follow-up data will continue to be collected solely via national digital registries for UK participants only. Participating sites will no longer collect follow-up data via the aforementioned methods of routine clinic visits, GP information requests, hospital tracking system, telephone contact or postal questionnaire. Participating sites have been closed and will no longer provide this follow-up data to the Barts Clinical Trials Unit. Previous interventions: There are no trial drugs or treatments associated with this observational study. Patients should be reviewed for recurrence of breast cancer at all follow-up visits. The site and date of confirmed first loco-regional and first distant recurrence will be recorded in the follow-up case report form (CRF). After loco-regional and distant recurrence patients will be followed for survival, new primary cancers and subsequent recurrences only. New breast primaries (either contralateral or ipsilateral) will be regarded as disease recurrence events in the statistical analyses of time to recurrence. All patients will be followed for survival. Patients will be registered with national death registries, where possible, e.g. ONS in UK. Cause of death will be recorded. New breast primaries: New breast primaries (either contralateral or ipsilateral), confirmed by histology or cytology, and with no other confirmed recurrence, will be recorded as a new breast primary. Additional information will be requested in order to determine whether the New Breast Primary is invasive or DCIS and whether it is oestrogen-receptor positive. Other cancers: New primary cancers confirmed by histology or cytology, or other diagnostic procedure. Ischaemic cardiac and cerebrovascular events, hip (and other) fractures: Serious cardiac or cerebrovascular events (such as myocardial infarct or stroke; not angina or transient ischaemic attack), all hip fractures, and fractures leading to an overnight stay in hospital. |
| Intervention type | Other |
| Primary outcome measure | 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). |
| Secondary outcome measures | To compare the long-term effects of tamoxifen (20 mg once daily [od]) and anastrozole (1 mg od) which were given in the ATAC trial (and who have all now completed treatment) as adjuvant therapy in terms of: 1. Time to distant recurrence 2. Cancer-specific survival 3. New breast primaries 4. Other cancers 5. Ischaemic cardiac and cerebrovascular events 6. Hip (and other) fractures |
| Overall study start date | 01/04/2009 |
| Completion date | 28/02/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 45 Years |
| Sex | Female |
| Target number of participants | 4437 participants internationally were eligible for further long-term follow-up in the LATTE study |
| Total final enrolment | 1342 |
| Key inclusion criteria | 1. Patients randomised to one of the monotherapy arms in the ATAC trial (randomised to the ATAC trial during the period 1996 - 2003 and were female, post-menopausal and 45 years and above at the time of randomisation) 2. Alive at 10 years follow-up |
| Key exclusion criteria | 1. Patients who have withdrawn consent to participate in the ATAC trial or this study 2. Where the LATTE Executive Committee determines that there is no possibility of obtaining follow-up |
| Date of first enrolment | 11/03/2010 |
| Date of final enrolment | 21/01/2019 |
Locations
Countries of recruitment
- Australia
- Belgium
- Canada
- England
- France
- Germany
- Italy
- Netherlands
- New Zealand
- South Africa
- Sweden
- United Kingdom
- United States of America
Study participating centre
London
E1 4NS
United Kingdom
Sponsor information
University/education
The Joint Research Management Office
Queen Mary Innovation Centre
Lower Ground Floor
5 Walden Street
London
E1 2EF
England
United Kingdom
| Phone | +44 (0)20 7882 7260 |
|---|---|
| research.governance@qmul.ac.uk | |
| Website | http://www.jrmo.org.uk/ |
"ROR" |
https://ror.org/026zzn846 |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Government organisation / For-profit companies (industry)
- Alternative name(s)
- AstraZeneca PLC, Pearl Therapeutics
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Current publication and dissemination plan as of 09/04/2024: The intention is to publish the main results from the study in approximately 2026 (when median follow-up reaches 15 years) in a high-impact peer-reviewed journal. Following this, the aim is to publish an updated manuscript on the benefits of aromatase inhibitors (AI) therapy in 2026/2027. Previous publication and dissemination plan: The intention is to publish the main results from the study in 2018 in a high-impact peer-reviewed journal. Following this, the aim is to publish an updated manuscript on the benefits of aromatase inhibitors (AI) therapy in 2022/2023. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository. An application process is in place for researchers wishing to use the LATTE data outside of those specified in the study protocol. In brief, a proposal for new analysis is formally assessed via the submission of a Request for New Analysis (RNA) form to the LATTE Executive and Advisory Committees. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | 100-month follow-up conference abstract | 01/02/2017 | 25/02/2019 | No | No |
| Results article | 10-year follow-up results | 01/12/2010 | 25/02/2019 | Yes | No |
| Results article | results | 01/11/2003 | 25/02/2019 | Yes | No |
| Results article | results | 01/01/2008 | 25/02/2019 | Yes | No |
Editorial Notes
24/04/2025: Contact details updated.
09/04/2024: The following changes have been made:
1. IRAS number added.
2. The latest ethics renewal (Renewal 3) was added for a Research Database (renewable every 5 years).
3. The overall study end date was changed from 28/02/2024 to 28/02/2026.
4. The publication and dissemination plan was changed and the intention to publish date was updated from 31/12/2018 to 31/12/2026.
5. The centre address was amended.
6. Total final enrolment added.
7. Interventions updated.
8. AstraZeneca was added to the plain English summary as a funder.
11/04/2019: Internal review.
25/02/2019: The following changes were made to the trial record:
1. The trial website was changed from http://www.cptu.org.uk/latte to https://www.qmul.ac.uk/wolfson/research-projects/current-projects/projects/latte-study.html
2. The intervention type was changed from 'Drug' to 'Other'.
3. The overall end date was changed from 21/01/2019 to 28/02/2024.
4. Participant inclusion criteria: Target number of participants was changed from "4437 participants are eligible for further long-term follow-up in the LATTE study" to "4437 participants internationally were eligible for further long-term follow-up in the LATTE study"
5. The recruitment end date was changed from 31/12/2017 to 21/01/2019.
6. The sponsor's email address and website were updated.
7. Publication references added.
10/04/2017: The following changes have been made to the record:
1. The overall trial end date has been updated from 01/04/2014 to 21/01/2019
1. The recruitment dates have been updated from 01/04/2009 - 01/04/2014 to 11/03/2010 - 31/12/2017
3. The publication and dissemination plan, IPD sharing plan and plain English summary have been added.
15/03/2017: No publications found in PubMed, verifying study status with principal investigator
02/11/2012: The following changes were made to this record:
1. Canada, Czech Republic, Ireland, Poland, Portugal, Slovakia and Turkey were removed from the countries of recruitment
2. The target number of participants was updated from 4548 to 4437
