Plain English Summary
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 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?
Patients will benefit from having regular monitoring by participating in the study. 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 January 2019
Who is funding the study?
Cancer Research UK (UK)
Who is the main contact?
Professor Jack Cuzick
j.cuzick@qmul.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Jack Cuzick
ORCID ID
http://orcid.org/0000-0001-7420-7512
Contact details
Centre for Cancer Prevention
Queen Mary University of London
Wolfson Institute of Preventive Medicine
Charterhouse Square
London
EC1M 6BQ
United Kingdom
+44 (0)20 7882 3504
j.cuzick@qmul.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT01745289
Protocol/serial number
C569/A10400
Study information
Scientific title
Long-term Anastrozole versus Tamoxifen Treatment Effects in breast cancer: an epidemiologial observational study
Acronym
LATTE
Study hypothesis
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
South East Research Ethics Committee, 19/01/2009
Study design
International multicentre epidemiological observational study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
No participant information sheet available
Condition
Breast cancer
Intervention
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
Drug
Phase
Not Applicable
Drug names
Anastrozole, tamoxifen
Primary outcome measures
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 trial start date
01/04/2009
Overall trial end date
21/01/2019
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
4437 participants are eligible for further long-term follow-up in the LATTE study
Participant 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
Recruitment start date
11/03/2010
Recruitment end date
31/12/2017
Locations
Countries of recruitment
Australia, Belgium, Canada, France, Germany, Italy, Netherlands, New Zealand, South Africa, Sweden, United Kingdom, United States of America
Trial participating centre
Centre for Cancer Prevention
London
EC1M 6BQ
United Kingdom
Sponsor information
Organisation
Queen Mary University of London (UK)
Sponsor details
The Joint Research Management Office
Queen Mary Innovation Centre
Lower Ground Floor
5 Walden Street
London
E1 2EF
United Kingdom
+44 (0)20 7882 7260
gerry.leonard@bartsandthelondon.nhs.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK) (ref: C569/A10400)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Funder name
AstraZeneca (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United Kingdom
Results and Publications
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 which, 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 assess via the submission of a Request for New Analysis (RNA) form to the LATTE Executive and Advisory Committees.
Intention to publish date
31/12/2018
Participant level data
Stored in repository
Results - basic reporting
Publication summary