National randomised trial of hormone replacement therapy (HRT) in women with a history of early stage breast cancer
| ISRCTN | ISRCTN29941643 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29941643 |
| ClinicalTrials.gov number | NCT00079248 |
| Secondary identifying numbers | N/A |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 28/01/2019
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Contact information
Ms Lisa Lloyd
Scientific
Scientific
Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU)
Section of Epidemiology
Brookes Lawley Building
Cotswold Road
Sutton, Surrey
SM2 5NG
United Kingdom
| Phone | +44 (0)208 722 4063 |
|---|---|
| lisa.lloyd@icr.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | National randomised trial of hormone replacement therapy (HRT) in women with a history of early stage breast cancer |
| Study acronym | HRT |
| Study hypothesis | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Breast |
| Intervention | 1. HRT 2. No HRT (advice about non-hormonal alternatives) Trial was closed early (December 2005) due to poor recruitment. |
| Intervention type | Other |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/08/2003 |
| Overall study end date | 01/08/2006 |
| Reason abandoned (if study stopped) | Participant recruitment issues |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target number of participants | Modified 25/02/2010: 3000 |
| Participant inclusion criteria | 1. Patients must have had proven stage I/II breast cancer with no clinical evidence of recurrence since diagnosis 2. Have been given a patient information pack 3. Be postmenopausal as defined by: a. Having been amenorrhoeic for at least 6 months (including women who have had radiation or chemical induced ovarian suppression) irrespective of menopausal status at time of diagnosis b. Having received surgical bilateral oophorectomy c. Be experiencing vasomotor symptoms (i.e. hot flushes or night sweats) with or without vaginal dryness. All such women are eligible irrespective of current/previous treatment for breast cancer. |
| Participant exclusion criteria | Not provided at time of registration |
| Recruitment start date | 01/08/2003 |
| Recruitment end date | 01/08/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU)
Sutton, Surrey
SM2 5NG
United Kingdom
SM2 5NG
United Kingdom
Sponsor information
Individual Sponsor (UK)
Research organisation
Research organisation
C/o Mr Nigel Sacks
The Royal Marsden NHS Trust
London
SM2 5NG
United Kingdom
| Phone | +44 (0) 20 8722 4373 |
|---|---|
| Claire.Dawson@icr.ac.uk | |
| Website | http://www.cancer.org.uk |
Funders
Funder type
Charity
Cancer Research UK
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
28/01/2019: No publications found, verifying results with the principal investigator
