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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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