| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN92834934 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | C90 |
| Public title | A Study Comparing CMF (Cyclophosphamide, Methotrexate, 5-fluorouracil) and MMM (Mitozantrone, Methotrexate, Mitomycin-C) Chemotherapy in Patients with Metastatic 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. Histologically proven breast cancer, metastatic or incurable locally recurrent disease
2. No other malignancy except adequately treated in situ carcinoma of cervix or non melanomatous skin cancer
3. Previous adjuvant chemotherapy or neo-adjuvant chemotherapy is acceptable, unless the disease free interval is <2 years following adjuvant CMF chemotherapy
4. Previous chemotherapy for metastatic disease is acceptable
5. Patients must be willing to complete quality of life questionnaire and be interviewed by a senior nurse
6. Normal liver function
7. Patients are not eligible if they are eligible for a first line phase II study. Patients may become eligible at the time of progression
8. Patient are not eligible if they present with immediately life threatening disease for whom the physician considers an anthracycline based combination preferable
9. Patients must be considered fit enough to receive either standard CMF or MMM 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 | Patients will be randomised to one of the following:
1. CMF Regimen: Chemotherapy with CMF (cyclophosphamide, methotrexate, 5-fluorouracil), a maximum of six cycles. Folinic acid to be given every 6 h for four doses commencing 24 h after chemotherapy.
2. MMM Regimen: Chemotherapy, MM (mitozantrone, methotrexate) alternating with MMM (mitozantrone, methotrexate, mitomycin-C), a maximum of six cycles in total. Folinic acid to be given every 6 h for four doses commencing 24 h after chemotherapy. |
| 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 | ISRCTN92834934 |
| Date last extracted from ISRCTN register | 17/04/2008 |
