Condition category
Cancer
Date applied
19/03/2009
Date assigned
30/03/2009
Last edited
10/04/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

http://www.cptu.org.uk/latte

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

http://www.qmul.ac.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK) (ref: C569/A10400)

Alternative name(s)

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

Publication citations

Additional files

Editorial Notes

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