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 (NCT) | NCT00079248 |
| Protocol serial number | N/A |
| Sponsor | Individual Sponsor (UK) |
| Funder | Cancer Research UK |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | National randomised trial of hormone replacement therapy (HRT) in women with a history of early stage breast cancer |
| Study acronym | HRT |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/08/2006 |
| Reason abandoned (if study stopped) | Participant recruitment issues |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target sample size at registration | 3000 |
| Key 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. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/08/2003 |
| Date of final enrolment | 01/08/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU)
Sutton, Surrey
SM2 5NG
United Kingdom
SM2 5NG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Editorial Notes
28/01/2019: No publications found, verifying results with the principal investigator
