An adjuvant randomised study comparing standard dose FE[50]C with a higher dose FE[75]C and evaluating the additional benefit of sequential hormone therapy in node positive pre-menopausal primary breast cancer
- Conditions
- Breast cancerCancerMalignant neoplasm of breast
- Registration Number
- ISRCTN98335268
- Lead Sponsor
- Pharmacia Ltd & Upjohn (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 0
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
Not provided at time of registration
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ot provided at time of registration
- Secondary Outcome Measures
Name Time Method ot provided at time of registration