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| NB: The information displayed below does not replace the protocol. The latest protocol version should always be consulted before making clinical decisions. |
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Neo-tAnGo
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A neoadjuvant 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.
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Topic
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Cancer
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Portfolio Eligibility
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Funded by UKCRC partner
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ISRCTN
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78234870
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EudraCT
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2004-002356-34
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MREC N° |
04/MRE01/60
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UKCRN ID |
1229
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WHO ID
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Study Type |
Interventional
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Design Type |
Treatment
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Disease(s) |
Breast
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Phase |
III
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Current Status
| Closed - in follow-up |
| Closure Date | 28/09/2007 |
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Sample Size
| 800 |
| Accrual to Date |
 | 103% |
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Geographical Scope
| UK Multi-Centre |
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Lead Country
| England (also active in Scotland and Wales) |
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Main Inclusion Criteria
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1. Women with histological diagnosis of invasive breast cancer. 2. T2 tumour or above (ultrasound size > 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, and renal function.* 6. ECOG performance status of 0, 1, or 2. 7. No previous chemotherapy or radiotherapy. 8. No previous diagnosis of malignancy unless: - managed by surgical treatment only, and disease-free for 10 years . - previous basal cell carcinoma, cervical carcinoma in situ or ductal carcinoma in situ of the breast treated by surgery only. 9. Non-pregnant and non-lactating, with no intention of pregnancy during chemotherapy, and prepared to adopt adequate contraceptive measures if pre-menopausal and sexually active. 10. No concomitant medical or psychiatric problems that might prevent completion of treatment or follow-up. 11. 18 years or older 12. Written informed consent for the study. 13. Randomisation must t
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Main Exclusion Criteria
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1. T0 and T1 tumours (ultrasound size < or = 20 mm) 2. Patient unfit to receive any of the trial chemotherapy regimens. 3. Evidence of metastatic disease. 4. History of atrio-ventricular arrhythmias and/or congestive heart failure, even where it is under medical control, or active second or third degree cardiac block. History of myocardial infarct during the 6 months prior to recruitment. Non-controlled or malignant arterial high-pressure. 5. Males
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Chief Investigator(s)
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| Dr Helena Earl |
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Further details, please contact
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Dr Sarah Bowden
Cancer Research UK Institute for Cancer Studies
University of Birmingham Edgbaston Birmingham West Midlands B15 2TT UNITED KINGDOM
Tel: 0121 414 4371 S.J.Bowden@BHam.ac.uk
| Scott Regan
University of Birmingham Edgbaston Birmingham West Midlands B15 2TT UNITED KINGDOM
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Funder(s) |
Bristol Myers Squibb Cancer Research UK Eli Lilly and Company Limited
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Sponsor(s) |
Cambridge University Hospitals NHS Foundation Trust University of Cambridge
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