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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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Research Summary
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Some women diagnosed with early breast cancer are advised to have chemotherapy before surgery (neoadjuvant chemotherapy). The aim of this neoadjuvant breast cancer study is to determine the benefit of adding gemcitabine (a newer anticancer chemotherapy drug) to epirubicin, cyclophosphamide and paclitaxel (standard chemotherapy treatment) in the neoadjuvant setting.
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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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