| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN17222211 |
| Date ISRCTN assigned | 22/03/2001 |
| Local reference number(s) | BR3009 |
| Public 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 |
| Scientific title |
|
| Acronym | aTTom |
| Disease/condition/study domain | Breast cancer |
| Study hypothesis | To assess reliably, the balance of benefits and risks of prolonging adjuvant tamoxifen treatment by 5 years, in women with early breast cancer |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/01/1994 |
| Anticipated end date | 01/08/2014 |
| Status of trial | Ongoing |
| Target number of participants | 8000 |
| Interventions | Group A - No further treatment with tamoxifen
Group B - At least 5 years further treatment with tamoxifen |
| Primary outcome measure(s) | To detect or refute reliably any overall survival benefit from extending the duration of therapy with adjuvant tamoxifen |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | CRC, UKCCCR, ICRF, MRC, CRUK |
| Sponsor name | The University of Birmingham (UK) |
| Sponsor details | Edgbaston
Birmingham
United Kingdom
B15 2TT |
| Contact name | Mr Martin J Lee |
| Contact details | Birmingham Clinical Trials Unit
University of Birmingham
Park Grange, 1 Somerset Road
Edgbaston
Birmingham
United Kingdom
B15 2RR |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN17222211 |
| Date last extracted from ISRCTN register | 17/04/2008 |
