A Study Comparing CMF (Cyclophosphamide, Methotrexate, 5-fluorouracil) and MMM (Mitozantrone, Methotrexate, Mitomycin-C) Chemotherapy in Patients with Metastatic Breast 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

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Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A Study Comparing CMF (Cyclophosphamide, Methotrexate, 5-fluorouracil) and MMM (Mitozantrone, Methotrexate, Mitomycin-C) Chemotherapy in Patients with Metastatic 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	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.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	CMF (cyclophosphamide, methotrexate, 5-fluorouracil), MM (mitozantrone, methotrexate), MMM (mitozantrone, methotrexate, mitomycin-C)
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2005

Participant type(s)	Patient
Age group	Adult
Sex	Female
Key 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 must be considered fit enough to receive either standard CMF or MMM chemotherapy
Key exclusion criteria	1. Patients are not eligible if they are eligible for a first line phase II study. Patients may become eligible at the time of progression 2. Patient are not eligible if they present with immediately life threatening disease for whom the physician considers an anthracycline based combination preferable
Date of first enrolment	01/01/2000
Date of final enrolment	31/12/2005

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan