Adjuvant 5-Fluorouracil, 4-Epidoxorubicin and Cyclophosphamide (FEC) versus Cyclophosphamide, Methotrexate and 5-Fluorouracil (CMF) in Premenopausal Node Positive Primary Breast Cancer
- Conditions
- BreastCancer
- Registration Number
- ISRCTN27799222
- Lead Sponsor
- Pharmacia Ltd & Upjohn (UK)
- Brief Summary
1. 1993 design and rationale in https://www.ncbi.nlm.nih.gov/pubmed?term=7693422 2. 1996 results in https://www.ncbi.nlm.nih.gov/pubmed?term=8558217
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 0
1. 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
Not provided at time of registration
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method