| Source of record | UK Trials |
| ISRCTN | ISRCTN43589852 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | BR305 |
| Public title | Clinical trial of six versus three courses of cyclophosphamide, methotrexate and 5-fluorouracil adjuvant chemotherapy in the treatment of pre-menopausal women with carcinoma of the breast |
| 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. Histologically proven invasive carcinoma of the breast
2. Aged <50 years
3. Axillary node positive with less than ten positive nodes, or node negative and deemed to be high risk: Grade 3; Grade 2 and tumour >2 cm; Grade 1 and tumour >5 cm
4. No evidence of distant metastases
5. No other malignancy, other than basal cell carcinoma or in situ cervical cancer or any malignancy with a similar prognosis
6. No previous chemotherapy
7. No contraindications to treatment protocols |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated end date | 19/09/1996 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | All patients receive surgery followed by:
1. Group A: Chemotherapy, cyclophosphamide, methotrexate and 5-fluorouracil (CMF) repeated every 4 weeks for three cycles.
2. Group B: Chemotherapy, cyclophosphamide, methotrexate and 5-fluorouracil (CMF) repeated every 4 weeks for six cycles. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Cancer Research UK |
| Sponsor name | Cancer Research UK |
| Sponsor details | PO Box 123
Lincoln's Inn Fields
London
United Kingdom
WC2A 3PX |
| Sponsor telephone | +44 (0)20 7317 5186 |
| Sponsor fax | +44 (0)20 7487 4302 |
| Sponsor email | kate.law@cancer.org.uk |
| Sponsor website | http://www.cancer.org.uk |
| 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 | ISRCTN43589852 |
| Date last extracted from ISRCTN register | 17/04/2008 |
