| Source of record | UK Trials |
| ISRCTN | ISRCTN92329652 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | B27 |
| Public title | Multicentre Cancer Chemotherapy Group Randomised Trial of Adjuvant Chemotherapy for 'Early' Breast Cancer |
| Scientific title |
|
| Acronym | Not Applicable |
| Disease/condition/study domain | Breast |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Following initial local therapy, surgery with or without radiotherapy, patients are randomised to one of two 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. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Action Cancer Belfast |
| Sponsor name | Action Cancer Belfast |
| Sponsor details | 1 Marlborough Park
Belfast
United Kingdom
BT9 6XS |
| Sponsor telephone | +44(0)2890803344 |
| Sponsor fax | +44(0)2890803356 |
| Sponsor website | http://www.actioncancer.org |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN92329652 |
| Date last extracted from ISRCTN register | 17/04/2008 |
