Adjuvant Tamoxifen Treatment - offer more? To assess reliably the balance of benefits and risks of prolonging adjuvant tamoxifen treatment by 5 years for women with breast cancer
| ISRCTN | ISRCTN17222211 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17222211 |
| ClinicalTrials.gov (NCT) | NCT00003678 |
| Protocol serial number | BR3009 |
| Sponsor | The University of Birmingham (UK) |
| Funders | Cancer Research UK (UK), Medical Research UK (UK) |
- Submission date
- 22/03/2001
- Registration date
- 22/03/2001
- Last edited
- 23/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
http://cancerhelp.cancerresearchuk.org/trials/tamoxifen-for-early-stage-breast-cancer
Contact information
Scientific
Birmingham Clinical Trials Unit
University of Birmingham
Park Grange, 1 Somerset Road
Edgbaston
Birmingham
B15 2RR
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Adjuvant Tamoxifen Treatment - offer more? To assess reliably the balance of benefits and risks of prolonging adjuvant tamoxifen treatment by 5 years for women with breast cancer |
| Study acronym | aTTom |
| Study objectives | To assess reliably, the balance of benefits and risks of prolonging adjuvant tamoxifen treatment by 5 years, in women with early breast cancer |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Breast cancer |
| Intervention | Group A - No further treatment with tamoxifen Group B - At least 5 years further treatment with tamoxifen |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Tamoxifen |
| Primary outcome measure(s) |
To detect or refute reliably any overall survival benefit from extending the duration of therapy with adjuvant tamoxifen |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/08/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 8000 |
| Total final enrolment | 6953 |
| Key inclusion criteria | 1. Any woman who has had complete excision of breast carcinoma 2. Any primary treatment 3. At least 2 years of prior adjuvant tamoxifen treatment (5 recommended) 4. Clinically relapse free 5. No definite indications or contraindications for further tamoxifen treatment: uncertainty as to whether further tamoxifen treatment will be of benefit 6. Where possible, ER status should be known prior to randomisation |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1994 |
| Date of final enrolment | 01/08/2014 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
B15 2RR
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2019 | 23/10/2020 | Yes | No |
| Plain English results | No | Yes |
Editorial Notes
23/10/2020: Publication reference added.
20/06/2019: Internal review.
14/06/2019: No publications found. Verifying results with principal investigator.
17/10/2018: Cancer Research UK lay results summary link added to Results (plain English).
07/06/2018: Conference proceedings added to publication and dissemination plan.
