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EndoTAG-1 + Paclitaxel in Neoadjuvant HER2-negative Breast Cancer
NCT01537536Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2011
- Primary completion
- Sep 2012
- Countries
- 1
- Sponsor
- Institut Jules Bordet
- Modality
- Small Molecules
- Drugs
- EndoTAG-1
- Conditions
- breast cancer
01
Overview
Phase 2, open-label, single-arm trial of EndoTAG-1 in breast cancer, sponsored by Institut Jules Bordet. Primary endpoint: MRI-estimated tumour volume reduction at 15 weeks. Started Nov 2011; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
EndoTAG-1 + Paclitaxel -> FEC
Neoadjuvant EndoTAG-1 + Paclitaxel followed by FEC
03
Who it enrols
Female patients >= 18 years with newly diagnosed, histologically confirmed HER2-negative breast cancer (infiltrating carcinoma grade > 1) candidate for neoadjuvant chemotherapy. Must have ECOG 0-1 and adequate organ function.
04
Endpoints
Primary
MRI-estimated tumour volume reduction
Secondary
Pathological Complete Response
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