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
ISRCTN | ISRCTN43589852 |
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DOI | https://doi.org/10.1186/ISRCTN43589852 |
Secondary identifying numbers | BR305 |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 21/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- 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
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 |
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 | 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 |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | Cyclophosphamide, methotrexate and 5-fluorouracil |
Primary outcome measure | Not provided at time of registration |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/01/1994 |
Completion date | 19/09/1996 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | Not provided at time of registration |
Key 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 |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 01/01/1994 |
Date of final enrolment | 19/09/1996 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Cancer Research UK (CRUK) (UK)
Charity
Charity
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
Phone | +44 (0)207 317 5186 |
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kate.law@cancer.org.uk | |
Website | http://www.cancer.org.uk |
https://ror.org/054225q67 |
Funders
Funder type
Charity
Cancer Research UK
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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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 |
Editorial Notes
21/11/2019: No publications found. All search options exhausted.