Breast cancer Cancer Malignant neoplasm of the breast
Conditions
Interventions
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: Chemothe
Sponsors
Pharmacia Ltd & Upjohn (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Not provided at time of registration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed