ational breast cancer study of Epirubicin plus CMF versus classical CMF Adjuvant Therapy
- Conditions
- BreastCancer
- Registration Number
- ISRCTN42625759
- Lead Sponsor
- niversity of Birmingham (UK)
- Brief Summary
1. 2006 results in https://www.ncbi.nlm.nih.gov/pubmed/17079759 2. 2008 results in https://www.ncbi.nlm.nih.gov/pubmed/18797468 (added 25/01/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 2028
1. Histological diagnosis of invasive breast cancer
2. Clinically early stage disease
3. Definitive surgery (either wide local excision or mastectomy) to the breast with complete excision of tumour
4. In the opinion of the clinician there is a definite indication for adjuvant chemotherapy, or the patient has been randomised to receive chemotherapy in the ABC study
5. Fit to receive chemotherapy in either of the two arms
6. No previous radiotherapy or chemotherapy
7. Adequate renal, hepatic and bone marrow function
8. Randomisation within 6 weeks of surgery, ideally within 1 month
9. No previous malignancy except, basal cell carcinoma or in situ carcinoma of the cervix
Not provided at time of registration
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. 5 year disease-free survival<br> 2. 5 year overall survival<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Acute toxicity comparison between the two study arms<br> 2. Quality of life and limited health economic comparisons between the two study arms, in a subset of 300 patients from designated centres<br>