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
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

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleClinical 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 objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedBreast cancer
InterventionAll 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Cyclophosphamide, methotrexate and 5-fluorouracil
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1994
Completion date19/09/1996

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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 criteriaNot provided at time of registration
Date of first enrolment01/01/1994
Date of final enrolment19/09/1996

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Cancer Research UK (CRUK) (UK)
Charity

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

Phone +44 (0)207 317 5186
Email kate.law@cancer.org.uk
Website http://www.cancer.org.uk
ROR logo "ROR" https://ror.org/054225q67

Funders

Funder type

Charity

Cancer Research UK
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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

21/11/2019: No publications found. All search options exhausted.