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EndoTAG-1 in Triple Receptor Negative Breast Cancer
NCT00448305Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2007
- Primary completion
- Feb 2010
- Countries
- 6
- Sponsor
- Medigene AG
- Modality
- Small Molecules
- Drugs
- EndoTAG-1
- Conditions
- triple-negative breast cancer (TNBC)
01
Overview
Phase 2, randomised, open-label trial of EndoTAG-1 in triple-negative breast cancer (TNBC) (3 arms), sponsored by Medigene AG. Primary endpoint: 4-month progression free survival rate. Started Jan 2007; status: completed.
02
Design
3 arms- Study design
- RandomizedOpen-label
EndoTAG-1 + Paclitaxel
EndoTAG-1 22 mg/m2 + Paclitaxel 70 mg/m2 weekly
EndoTAG-1 Monotherapy
EndoTAG-1 44 mg/m2 twice weekly
Paclitaxel Control
Paclitaxel 90 mg/m2 weekly
03
Who it enrols
Female patients >= 18 years with histologically proven triple-receptor-negative metastatic or relapsed breast cancer, ECOG 0-2, and max 1 prior chemotherapy for metastatic disease.
04
Endpoints
Primary
4-month progression free survival rate
Secondary
Median Progression Free Survival
Tumor Response
4-month survival rate
Median Overall Survival
Pain Assessment
Quality of Life
Adverse Events
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