eoadjuvant study of sequential epirubicin/cyclophosphamide and paclitaxel ± gemcitabine in the treatment of high risk early breast cancer with molecular profiling, proteomics and candidate gene analysis

Cambridge University Hospitals NHS Foundation Trust (UK)0 个研究点目标入组 800 人开始时间: 2004年12月20日最近更新: 2018年11月12日

适应症

试验速览

•1. Women with histological diagnosis of invasive breast cancer
•2. T2 tumour or above (ultrasound size mroe than 20 mm)
•3. Any hormone receptor status
•4. Patient fit to receive any of the trial chemotherapy regimens
•5. Patient must have adequate bone marrow, hepatic, renal, and cardiac function
•6. Eastern Cooperative Oncology Group (ECOG) performance status of zero, one, or two
•7. No previous chemotherapy or radiotherapy
•8. No previous malignancy except basal cell carcinoma or cervical carcinoma in situ, unless disease-free for ten years, after surgical treatment only
•9. Chemotherapy should start as soon as possible but must commence within four weeks of biopsy
•10. Randomisation needs to take place within three weeks of biopsy
•11. Non-pregnant and non-lactating
•12. No concomitant medical or psychiatric problems that might prevent completion of treatment or follow-up
•13. 18 years or older
•14. Written informed consent for the study

•1. Previous treatment with irinotecan
•2. Any condition requiring ongoing ciclosporin treatment
•3. Ongoing treatment with cetuximab (NB previous cetuximab is not an exclusion criterion, provided it has stopped more than three weeks before randomisation)
•4. If a female of child-bearing age, a positive pregnancy test, or not using adequate contraception
•5. Concurrent or previous other cancer (excluding non-melanomatous skin cancer)
•6. Known Central Nervous System (CNS) metastases, carcinomatous meningitis or recent history of seizures
•7. Major thoracic or abdominal surgery within preceding four weeks
•8. Chronic enteropathy (e.g. Crohn's disease, ulcerative colitis)
•9. Chronic diarrhoea of any cause, whether or not related to the colorectal cancer or surgery
•10. Unresolved bowel obstruction
•11. Uncontrolled infection
•12. Incapable of reliable oral self-medication
•13. Any other condition, which, in the investigator's opinion would make the patient unsuitable for participation in the trial

发起方