The NCRI adjuvant breast cancer (ABC) trial
| ISRCTN | ISRCTN31514446 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31514446 |
| ClinicalTrials.gov (NCT) | NCT00002582 |
| Protocol serial number | G9437812 |
| Sponsor | Institute of Cancer Research (UK) |
| Funder | Medical Research Council (UK) |
- Submission date
- 06/04/2000
- Registration date
- 06/04/2000
- Last edited
- 07/05/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Judith Bliss
Scientific
Scientific
Section of Epidemiology
The Institute of Cancer Research
15 Cotswold Road
Sutton
SM2 5NG
United Kingdom
| Phone | +44 (0)20 8722 4040 |
|---|---|
| abc-icrctsu@icr.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study acronym | ABC |
| Study objectives | To determine the value of adding cytotoxic chemotherapy and/or (in premenopausal women) ovarian suppression to prolonged tamoxifen 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 | Cytotoxic chemotherapy and/or (in premenopausal women) ovarian suppression and prolonged tamoxifen/tamoxifen |
| Intervention type | Other |
| 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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 6000 |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1993 |
| Date of final enrolment | 30/09/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Section of Epidemiology
Sutton
SM2 5NG
United Kingdom
SM2 5NG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 04/04/2007 | Yes | No | |
| Results article | results | 14/03/2012 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
