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

ISRCTN	ISRCTN92834934
DOI	https://doi.org/10.1186/ISRCTN92834934
Secondary identifying numbers	C90

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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
Pharmaceutical study type(s)
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	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

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	Not provided at time of registration
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

Cancer Research UK (CRUK) (UK)
Charity

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations

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