Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ICCG/6/89
Study information
Scientific title
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
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2003
Overall trial end date
01/01/2004
Reason abandoned
Eligibility
Participant 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
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
01/01/2003
Recruitment end date
01/01/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Pharmacia Ltd & Upjohn (UK)
Sponsor details
Davy Avenue
Milton Keynes
MK5 8PH
United Kingdom
+44 (0)1908 661101
info@adreco.co.uk
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Pharmacia and Upjohn (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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