The NCRI adjuvant breast cancer (ABC) trial
| ISRCTN | ISRCTN31514446 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31514446 |
| ClinicalTrials.gov number | NCT00002582 |
| Secondary identifying numbers | G9437812 |
- 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
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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | ABC |
| 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. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Breast cancer |
| Intervention | Cytotoxic chemotherapy and/or (in premenopausal women) ovarian suppression and prolonged tamoxifen/tamoxifen |
| Intervention type | Other |
| Primary outcome measure | 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 measures | Not provided at time of registration |
| Overall study start date | 01/01/1993 |
| Overall study end date | 30/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 6000 |
| Participant 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 |
| Participant exclusion criteria | Not provided at time of registration |
| Recruitment start date | 01/01/1993 |
| Recruitment end date | 30/09/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Section of Epidemiology
Sutton
SM2 5NG
United Kingdom
SM2 5NG
United Kingdom
Sponsor information
Institute of Cancer Research (UK)
Research organisation
Research organisation
123 Old Brompton Road
London
SW7 3RP
United Kingdom
| Phone | +44 (0)20 7352 8133 |
|---|---|
| abc-icrctsu@icr.ac.uk | |
| Website | http://www.icr.ac.uk/ |
"ROR" |
https://ror.org/043jzw605 |
Funders
Funder type
Research council
Medical Research Council (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
