Adjuvant cyclophosphamide, methotrexate and 5-Fluorouracil (CMF) versus 5-Fluorouracil, epirubicin and cyclosphosphamide (FEC) in node negative poor-risk primary breast cancer
| ISRCTN | ISRCTN81164554 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81164554 |
| Secondary identifying numbers | ICCG/6/89 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 06/11/2012
- 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 |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| 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 | Patients randomised to receive chemotherapy will receive CMF or FEC no sooner than 2 weeks and no later than 4 weeks following primary surgery. Patients will receive either: 1. CMF Regimen: Chemotherapy, CMF (cyclophosphamide, methotrexate, 5-fluorouracil) repeated every 4 weeks for six cycles. 2. FEC Regimen: Chemotherapy, FEC (5-fluouracil, 4-epidoxorubicin, cyclophosphamide) repeated every 4 weeks for six cycles. |
| Intervention type | Other |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2003 |
| Completion date | 01/01/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | 1. Aged less than 65 years 2. Histologically proven invasive adenocarcinoma axillary nodes must be histologically negative 3. Tumour is T1c to T3 4. Tumour shows one of the following features of poor prognosis: 4.1. Oestrogen receptor less than or equal to 10 fmol/mg cytosol protein 4.2. Grade III 4.3. Vessel invasive 4.4. High labelling index of S phase 4.5. Aneuploidy 4.6. Tumour size at least 2 cm 5. Adequate renal, hepatic and haematological function 6. No evidence of metastatic disease 7. No evidence of inflammatory carcinoma 8. Patients with bilateral malignancy or with a mass in the opposite breast, unless there is biopsy proof that it is not a malignancy, are excluded 9. Patients with findings that relate them to a category of more advanced disease are not eligible 10. Patients with clinically positive nodes in the axilla opposite the affected breast, or with palpable supraclavicular or infraclavicular nodes are considered ineligible unless there is a biopsy evidence that these are not involved with the tumour 11. No previous or concomitant malignancy, except squamous or basal cell carcinoma which has been effectively treated and carcinoma in situ of the cervix which has been treated operatively 12. No prior therapy for the present breast cancer including radiotherapy, chemotherapy, immunotherapy and/or hormonal therapy 13. No non-malignant systemic disease which would preclude their being subjected to any of the treatment options or prevent prolonged follow up 14. No active or previous cardiac disease that would preclude the use of 4-epidoxorubicin 12. No psychiatric or addictive disorders which should preclude obtaining informed consent |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2003 |
| Date of final enrolment | 01/01/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Pharmacia Ltd & Upjohn (UK)
Industry
Industry
Davy Avenue
Milton Keynes
MK5 8PH
United Kingdom
| Phone | +44 (0)1908 661101 |
|---|---|
| info@adreco.co.uk | |
| Website | http://www.pharmacia.com |
"ROR" |
https://ror.org/04x4v8p40 |
Funders
Funder type
Industry
Pharmacia and Upjohn (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 |
