Adjuvant cyclophosphamide, methotrexate and 5-Fluorouracil (CMF) versus 5-Fluorouracil, epirubicin and cyclosphosphamide (FEC) in node negative poor-risk primary breast cancer
- Conditions
- Breast cancerCancerMalignant neoplasm of the breast
- Registration Number
- ISRCTN81164554
- Lead Sponsor
- Pharmacia Ltd & Upjohn (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 0
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
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