A collaborative trial to evaluate the role of radiotherapy and adjuvant tamoxifen in the conservative management of clinical stage I and II breast cancer
| ISRCTN | ISRCTN68177645 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68177645 |
| Protocol serial number | BR3002 |
| Sponsor | Cancer Research UK (CRUK) (UK) |
| Funder | Cancer Research UK |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 23/02/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
- -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A collaborative trial to evaluate the role of radiotherapy and adjuvant tamoxifen in the conservative management of clinical stage I and II breast cancer |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Breast cancer |
| Intervention | Following surgery to remove the tumour patients are randomised into one of six treatment groups: 1. Group A: Tamoxifen daily for 2 years 2. Group B: Tamoxifen daily until recurrence 3. Group C: Short radiotherapy plus tamoxifen daily for 2 years 4. Group D: Short radiotherapy plus tamoxifen daily until recurrence 5. Group E: Long radiotherapy plus tamoxifen daily for 2 years 6. Group F: Long radiotherapy plus tamoxifen daily until recurrence SYSTEMIC TREATMENT: Tamoxifen 20 mg daily to start immediately following surgery POST-OPERATIVE RADIOTHERAPY: Short Radiotherapy: 40 Gy in fifteen daily fractions given over 3 weeks with a supplementary boost to the local tumour site of 15 Gy in five daily fractions. Long Radiotherapy: 50 Gy in twenty-five daily fractions given over 5 weeks with a supplementary boost to the local tumour site of 15 Gy in five daily fractions. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Tamoxifen |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/1999 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | |
| Key inclusion criteria | 1. Histologically proven adenocarcinoma of breast 2. Tumour size <5 cm 3. No clinically palpable axillary nodes 4.. Have had an operation resulting in a cosmetically satisfactory breast 5. No evidence of systemic metastases 6. No previous treatment for a malignancy by radiotherapy or chemotherapy 7. Patients with Paget's disease of the nipple, bilateral breast cancer or lymphoedema of the breast are excluded 8. No previous or co-existing malignancies, except basal cell carcinoma of skin and in-situ carcinoma of cervix 9. Patients must be fit enough to receive any of the specified treatments |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1997 |
| Date of final enrolment | 31/12/1999 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
