Anastrozole in Preventing Breast Cancer in Postmenopausal Women at Increased Risk of Breast Cancer
- Registration Number
- NCT00078832
- Lead Sponsor
- Queen Mary University of London
- Brief Summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Anastrozole may be effective in preventing breast cancer.
PURPOSE: This randomized clinical trial is studying how well anastrozole works in preventing breast cancer in postmenopausal women who are at increased risk for the disease.
- Detailed Description
OBJECTIVES:
Primary
* Determine the effectiveness of anastrozole in preventing breast cancer in postmenopausal women at increased risk for the disease.
Secondary
* Determine the role of this drug in preventing estrogen receptor-positive breast cancer in these participants.
* Determine the effect of this drug on breast cancer mortality in these participants.
* Determine the effect of this drug on other cancers, cardiovascular disease, fracture rates, and non-breast cancer deaths in these participants.
* Determine the tolerability and acceptability of side effects of this drug in these participants.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Participants are stratified according to participating center. Participants are randomized to 1 of 2 treatment arms.
* Arm I: Participants receive oral anastrozole daily for 5 years.
* Arm II: Participants receive an oral placebo daily for 5 years. In both arms, treatment continues in the absence of the development of breast cancer (including ductal carcinoma in situ), a drop in the T-score below minus 4, or the occurrence of a new fragility fracture.
Participants are followed for at least a further 5 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
ACCRUAL: A total of 3,864 participants were recruited for this study over 10 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 3864
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description placebo placebo anastrozole 1mg PLACEBO anastrozole anastrozole anastrozole 1mg
- Primary Outcome Measures
Name Time Method Development of histologically confirmed breast cancer, both invasive and non-invasive with median follow-up at 5 years Dec 2013
- Secondary Outcome Measures
Name Time Method Breast cancer mortality with median follow-up at 10 years Dec 2018
Trial Locations
- Locations (73)
Pirkanmaa Cancer Society
🇫🇮Tampere, Finland
Sir Paul Boffa Hospital, Harper Lane
🇲🇹Floriana, Malta
Inselspital Bern
🇨ðŸ‡Bern, Switzerland
Royal Bournemouth Hospital
🇬🇧Bournemouth, England, United Kingdom
Corporacion Nacional del Cancer
🇨🇱Santiago, Chile
Instituto Portugues De Oncologia, Gabinete De Estudos Clinicos
🇵🇹Lisbon, Portugal
Tumor Zentrum ZeTup St. Gallen und Chur
🇨ðŸ‡St. Gallen, Switzerland
Regionalspital
🇨ðŸ‡Thun, Switzerland
Macclesfield District General Hospital
🇬🇧Macclesfield, England, United Kingdom
Tameside General Hospital
🇬🇧Ashton-Under-Lyne, England, United Kingdom
St. Luke's Hospital
🇬🇧Bradford, England, United Kingdom
Bristol Royal Infirmary
🇬🇧Bristol, England, United Kingdom
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
🇮🇪Dublin, Tallaght, Ireland
Centre for Cancer Research and Cell Biology at Queen's University Belfast
🇬🇧Belfast, Northern Ireland, United Kingdom
Singleton Hospital
🇬🇧Swansea, Wales, United Kingdom
Conquest Hospital
🇬🇧Hastings, England, United Kingdom
St. James's Hospital
🇮🇪Dublin, Ireland
Sligo General Hospital
🇮🇪Sligo, Ireland
Queen's Hospital
🇬🇧Burton-upon-Trent, England, United Kingdom
Frenchay Hospital
🇬🇧Bristol, England, United Kingdom
Countess of Chester Hospital
🇬🇧Chester, England, United Kingdom
University Hospital of Wales
🇬🇧Cardiff, Wales, United Kingdom
Royal Bolton Hospital
🇬🇧Bolton, England, United Kingdom
Saint Margaret's Hospital,
🇬🇧Epping, England, United Kingdom
Beaumont Hospital
🇮🇪Dublin, Beaumont, Ireland
University College Hospital
🇮🇪Galway, Ireland
Oncocare Sonnenhof-Klinik Engeriedspital
🇨ðŸ‡Bern, Switzerland
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom
Royal Marsden - London
🇬🇧London, England, United Kingdom
Broomfield Hospital
🇬🇧Chelmsford, England, United Kingdom
Gloucestershire Oncology Centre at Cheltenham General Hospital
🇬🇧Cheltenham, England, United Kingdom
Royal Devon and Exeter Hospital
🇬🇧Exeter, England, United Kingdom
Ninewells Hospital
🇬🇧Dundee, Scotland, United Kingdom
Edinburgh Cancer Centre at Western General Hospital
🇬🇧Edinburgh, Scotland, United Kingdom
Newcastle Mater Hospital
🇦🇺Newcastle, New South Wales, Australia
St. Vincent's University Hospital
🇮🇪Dublin, Ireland
Mid-Western Cancer Centre at Mid-Western Regional Hospital
🇮🇪Limerick, Ireland
Herlev University Hospital
🇩🇰Horsholm, Denmark
University Hospitals
🇧🇪Leuven, Belgium
Ospedale Beata Vergine
🇨ðŸ‡Mendrisio, Switzerland
Hopital Cantonal Universitaire de Geneve
🇨ðŸ‡Geneva, Switzerland
Sussex Cancer Centre at Royal Sussex County Hospital
🇬🇧Brighton, England, United Kingdom
Paterson Institute for Cancer Research
🇬🇧Manchester, United Kingdom
Treliske Royal Cornwall Hospital
🇬🇧Truro, United Kingdom
Calderdale Royal Hospital
🇬🇧Huddersfield, United Kingdom
Derriford Hospital
🇬🇧Plymouth, United Kingdom
Royal Free and UCL Medical School
🇬🇧London, United Kingdom
Mid Staffordshire NHS Foundation Trust
🇬🇧Stafford, United Kingdom
Department of General Surgery Pennine Acute Hospitals NHS Trust
🇬🇧Oldham, United Kingdom
Department of Oncotherapy, University of Szeged
ðŸ‡ðŸ‡ºSzeged, Hungary
GBG Forschungs GMBH
🇩🇪Frankfurt, Germany
Cork University Hospital
🇮🇪Cork, Ireland
South Infirmary Victoria Hospital
🇮🇪Cork, Ireland
Division of Chemoprevention
🇮🇹Milan, Italy
Ortaklar cad Pehlivan sok, Basak koviah ap.
🇹🇷Istanbul, Turkey
Saint Bartholomew's Hospital
🇬🇧London, England, United Kingdom
Lincoln County Hospital
🇬🇧Grantham, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, United Kingdom
Northwick Park Hospital
🇬🇧Middlesex, United Kingdom
School of Surgical & Reproductive Sciences
🇬🇧Newcastle, United Kingdom
Nottingham University Hospitals NHS Trust
🇬🇧Nottingham, United Kingdom
Wishaw General Hospital
🇬🇧Wishaw, United Kingdom
Weston Park Hospital, Cancer Clinical Trials Centre, Department of Clinical Oncology
🇬🇧Sheffield, United Kingdom
Princess Anne Hospital
🇬🇧Southampton, United Kingdom
Cancer Clinical Trials Centre
🇬🇧Sheffield, United Kingdom
Yeovil District Hospital
🇬🇧Yeovil, United Kingdom
Essex County Hospital
🇬🇧Colchester, England, United Kingdom
Royal Derby Hospital
🇬🇧Derby, England, United Kingdom
Frimley Park Hospital
🇬🇧Frimley, England, United Kingdom
Airedale General Hospital
🇬🇧Keighley, England, United Kingdom
Guy's Hospital
🇬🇧London, England, United Kingdom
Castle Hill Hospital
🇬🇧Hull, England, United Kingdom
Royal Liverpool University Hospital
🇬🇧Liverpool, England, United Kingdom