|
Welcome
|
|
23 May 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ ...Back to search results ] | [ Print-friendly version ] |
| LATTE: Long-term Anastrozole versus Tamoxifen Treatment Effects |
| ISRCTN | ISRCTN86305500 |
| ClinicalTrials.gov identifier | |
| Public title | LATTE: Long-term Anastrozole versus Tamoxifen Treatment Effects |
| Scientific title | Long-term Anastrozole versus Tamoxifen Treatment Effects in breast cancer: an epidemiologial observational study |
| Acronym | LATTE |
| Serial number at source | C569/A10400 |
| Study hypothesis |
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, to compare the long-term effects of treatment with tamoxifen alone and anastrozole alone as adjuvant therapy for breast cancer in post-menopausal women. The 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 6,000 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. |
| Lay summary | Not provided at time of registration |
| Ethics approval | South East Research Ethics Committee approved on the 19th January 2009 |
| Study design | International multicentre epidemiological observational study |
| Countries of recruitment | Australia, Belgium, Canada, Czech Republic, France, Germany, Hungary, Ireland, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Turkey, United Kingdom, United States of America, International |
| Disease/condition/study domain | Breast cancer |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/04/2009 |
| Anticipated end date | 01/04/2014 |
| Status of trial | Ongoing |
| Patient information material | Can be found at: http://www.cptu.org.uk/latte |
| Target number of participants | Approximately 4,548 patients |
| 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. |
| Primary outcome measure(s) | 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 measure(s) |
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 |
| Sources of funding |
1. Cancer Research UK (CRUK) (UK) (ref: C569/A10400)
2. AstraZeneca (UK) |
| Trial website | http://www.cptu.org.uk/latte |
| Publications | |
| Contact name | Prof Jack Cuzick |
| Address |
Cancer Research UK Centre for Epidemiology, Mathematics and Statistics
Wolfson Institute of Preventive Medicine Barts and The London School of Medicine and Dentistry Queen Mary, University of London Charterhouse Square |
| City/town | London |
| Zip/Postcode | EC1M 6BQ |
| Country | United Kingdom |
| Tel | +44 (0)20 7014 0227 |
| j.m.gorczynska@qmul.ac.uk | |
| Sponsor | Queen Mary University of London (UK) |
| Address |
Research & Development Office
24 - 26 Walden Street Whitechapel |
| City/town | London |
| Zip/Postcode | E1 2AM |
| Country | United Kingdom |
| Tel | +44 (0)20 7882 7260 |
| gerry.leonard@bartsandthelondon.nhs.uk | |
| Sponsor website: | http://www.qmul.ac.uk/ |
| Date applied | 19/03/2009 |
| Last edited | 30/08/2011 |
| Date ISRCTN assigned | 30/03/2009 |
|
|
|
|
|
| © 2012 ISRCTN unless otherwise stated. | |
|
|
|
|