Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
07/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

- - -

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

C90

Study information

Scientific title

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

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

CMF (cyclophosphamide, methotrexate, 5-fluorouracil), MM (mitozantrone, methotrexate), MMM (mitozantrone, methotrexate, mitomycin-C)

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2000

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Not provided at time of registration

Participant 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

Recruitment start date

01/01/2000

Recruitment end date

31/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Cancer Research UK (CRUK) (UK)

Sponsor details

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk

Sponsor type

Charity

Website

http://www.cancer.org.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes