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

Phase 3

Completed

• Conditions: Early breast cancer; Cancer; Malignant neoplasm of breast

• Registration Number: ISRCTN78234870
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust (UK)

Brief Summary

2008 sub-study results in: http://www.ncbi.nlm.nih.gov/pubmed/18665163 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24360787

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-12-20
• Study Completion: 2005-05-31
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 800

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Added 12/08/09:<br>Complete pathological response after 4 courses

Secondary Outcome Measures

Name	Time	Method
Added 12/08/09:<br>1. Overall survival<br>2. Disease-free survival<br>3. Effect of prognostic factors