Multicentre Cancer Chemotherapy Group Randomised Trial of Adjuvant Chemotherapy for 'Early' Breast Cancer
| ISRCTN | ISRCTN92329652 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92329652 |
| Secondary identifying numbers | B27 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 18/01/2016
- 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
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| 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 | Multicentre Cancer Chemotherapy Group Randomised Trial of Adjuvant Chemotherapy for 'Early' 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 initial local therapy, surgery with or without radiotherapy, patients are randomised to one of 2 treatment arms: 1. Arm A: Tamoxifen 10 mg twice daily for 12 months. 2. Arm B: A total of eight cycles of multidrug chemotherapy. Cyclophosphamide, vincristine and 5-fluorouracil to be given on day 1 and cyclophosphamide, vincristine and methotrexate on day 8 of each 3 week cycle. 3. Arm C: Multidrug chemotherapy with vincristine, methotrexate, chlorambucil and 5-fluorouracil repeated every 3 weeks for 8 cycles. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Tamoxifen, cyclophosphamide, vincristine, 5-fluorouracil, methotrexate, chlorambucil |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2000 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | 1. Aged <70 years 2. Operable primary breast cancer with tumour <5 cm in greatest diameter 3. Histologically proven axillary nose involvement 4. Adequate renal and liver function 5. No prior history of other malignant disease 6. No previous chemotherapy |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Action Cancer Belfast (UK)
Research organisation
Research organisation
1 Marlborough Park
Belfast
BT9 6XS
United Kingdom
| Phone | +44 (0)289 080 3344 |
|---|---|
| abc@email.com | |
| Website | http://www.actioncancer.org |
"ROR" |
https://ror.org/02mf6dg38 |
Funders
Funder type
Research organisation
Action Cancer Belfast (UK)
No information available
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 |
Editorial Notes
18/01/2016: no publications found on PubMed.
