Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
BR305
Study information
Scientific 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
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
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.
Intervention type
Drug
Phase
Not Applicable
Drug names
Cyclophosphamide, methotrexate and 5-fluorouracil
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1994
Overall trial end date
19/09/1996
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1994
Recruitment end date
19/09/1996
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
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
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