| Source of record | UK Trials |
| ISRCTN | ISRCTN31514446 |
| Date ISRCTN assigned | 06/04/2000 |
| Local reference number(s) | G9437812 |
| Public title | The NCRI adjuvant breast cancer (ABC) trial |
| Scientific title |
|
| Acronym | ABC |
| Disease/condition/study domain | Breast cancer |
| Study hypothesis | To determine the value of adding cytotoxic chemotherapy and/or (in premenopausal women) ovarian suppression to prolonged tamoxifen 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 | All women with early invasive breast cancer requiring adjuvant systemic therapy are eligible for the trial providing they have:
1. Early (operable) breast cancer
2. Histological confirmation of invasive carcinoma
3. No previous malignancy (except carcinoma in situ [CIS] cervix or basal cell carcinoma)
4. Received no previous systemic treatment for their disease
5. Given consent and available for subsequent follow-up |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/01/1993 |
| Anticipated end date | 30/09/2005 |
| Status of trial | Completed |
| Target number of participants | 6000 |
| Interventions | Cytotoxic chemotherapy and/or (in premenopausal women) ovarian suppression and prolonged tamoxifen/tamoxifen |
| Primary outcome measure(s) | The main endpoint used for evaluation of treatment efficacy will be overall survival based on all cause mortality. Relapse-free survival, breast cancer mortality and cardiovascular mortality will also be compared. In a subset of patients there will be a detailed assessment of quality of life. Health economic consequences will also be determined. Ongoing biological predictors of therapeutic response studies, funded by CRUK and BCC. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Trial website | http://www.icr.ac.uk/research/research_sections/clinical_trials/clinical_trials_list/2413_disease.shtml |
| Publications | Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17405996 |
| Sources of funding | Medical Research Council (UK) |
| Sponsor name | Institute of Cancer Research (UK) |
| Sponsor details | 123 Old Brompton Road
London
United Kingdom
SW7 3RP |
| Sponsor telephone | +44 (0)20 7352 8133 |
| Sponsor fax | +44 (0)20 7370 5261 |
| Sponsor email | abc-icrctsu@icr.ac.uk |
| Sponsor website | http://www.icr.ac.uk/ |
| Contact name | Ms Judith Bliss |
| Contact details | Section of Epidemiology
The Institute of Cancer Research
15 Cotswold Road
Sutton
United Kingdom
SM2 5NG |
| Contact telephone | +44 (0)20 8722 4040 |
| Contact fax | +44 (0)20 8 770 7876 |
| Contact email | abc-icrctsu@icr.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN31514446 |
| Date last extracted from ISRCTN register | 17/04/2008 |
