Breast cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
1. Regimen A: chemotherapy, FE[50]C repeated every three weeks for eight cycles followed by hormonal manipulation.
2. Regimen B: chemotherapy, FE[50]C repeated every three weeks for eight cycles.
3.
Sponsors
Pharmacia Ltd & Upjohn (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Histologically proven non-metastatic breast cancer 2. Received optimal axillary node sampling (at least seven nodes must be in the axillary dissection) 3. Between one and five histologically involved axillary nodes 4. Pre-menopausal that is: a. Last menstrual period within one year of randomisation, or b. Oestrogen and Follicle Stimulating Hormone (FSH)/Luteinising Hormone (LH) levels compatible with ovarian function, particularly if the patient has had a hysterectomy 5. Adequate renal, hepatic and haematological function 6. No bilateral malignancy 7. No inflammatory breast carcinoma 8. No clinically positive contralateral axillary or supraclavicular nodes, unless there is biopsy evidence that these are not involved with the tumour 9. No ulceration or infiltration of the skin 10. No satellite breast or parasternal nodules 11. No oedema of the arm 12. No medical contraindications to treatment protocols
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