Adjuvant 5-Fluorouracil, 4-Epidoxorubicin and Cyclophosphamide (FEC) versus Cyclophosphamide, Methotrexate and 5-Fluorouracil (CMF) in Premenopausal Node Positive Primary Breast Cancer

ISRCTN ISRCTN27799222
DOI https://doi.org/10.1186/ISRCTN27799222
Secondary identifying numbers ICCG/2/84
Submission date
19/08/2002
Registration date
19/08/2002
Last edited
11/01/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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)Not specified
Study typeNot Specified
Scientific titleAdjuvant 5-Fluorouracil, 4-Epidoxorubicin and Cyclophosphamide (FEC) versus Cyclophosphamide, Methotrexate and 5-Fluorouracil (CMF) in Premenopausal Node Positive Primary Breast Cancer
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedBreast
InterventionAll patients receive either a total mastectomy or tumour excision followed by radiotherapy. Eligible patients are randomised to receive:

A. PRE-MENOPAUSAL PATIENTS
1. Regimen A: Chemotherapy, 5-fluorouracil, 4-epidoxorubicin and cyclophosphamide (FEC), repeated every 3 weeks for a total of eight cycles.
2. Regimen B: Chemotherapy, cyclophosphamide, methotrexate and 5-fluorouracil (CMF), repeated every 4 weeks for a total of six cycles.

B. POST-MENOPAUSAL PATIENTS
3. Regimen C: Chemotherapy with FEC repeated every 3 weeks for a total of eight cycles.
4. Regimen D: No chemotherapy.
Intervention typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1987
Completion date15/04/1992

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participantsNot provided at time of registration
Key inclusion criteria1. Aged <65 years
2. Tumour confined to the breast or breast and ipsilateral axilla and considered operable
3. At least one axillary lymph node must show evidence of tumour on histological examination
4. On clinical examination, the axillary nodes should be moveable in relation to the chest wall and neurovascular bundle, and there should be no oedema of the arm
5. Adequate renal, hepatic and haematological function
6. No previous oophorectomy for breast carcinoma
7. No evidence of metastatic disease
8. Patients with advanced disease or ulceration, erythema, infiltration of the skin and oedema are ineligible
9. No previous concomitant malignancy, except squamous or basal cell carcinoma of the skin or carcinoma in-situ of the cervix
10. No non-malignant systemic disease which would preclude the use of any treatment within the trial
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/1987
Date of final enrolment15/04/1992

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Pharmacia Ltd & Upjohn (UK)
Industry

Davy Avenue
Milton Keynes
MK5 8PH
United Kingdom

Phone +44 (0)1908 661101
Email info@adreco.co.uk
Website http://www.pharmacia.com
ROR logo "ROR" https://ror.org/04x4v8p40

Funders

Funder type

Industry

Pharmacia and Upjohn

No information available

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

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Other publications design and rationale 01/08/1993 Yes No
Results article results 01/01/1996 Yes No

Editorial Notes

11/01/2019: Publication references added.