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Phase II, multicenter, open-label, clinical trial of Trabectedin (Yondelis®) in Metastatic Breast Cancer Patients with triple negative profile (ER-, PR-, HER2-), HER2 overexpressing tumors and BRCA1 o...

Update Il y a 4 ans
Reference: EUCTR2007-000794-31

Phase II, multicenter, open-label, clinical trial of Trabectedin (Yondelis®) in Metastatic Breast Cancer Patients with triple negative profile (ER-, PR-, HER2-), HER2 overexpressing tumors and BRCA1 or BRCA2 mutation carriers

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Extract

Primary Objective: to determine the objective response rate by RECIST (Complete and Partial Response [CR + PR]) with trabectedin in patients with the following metastatic breast cancer subtypes: Group A: triple negative profile (ER-,PR-,HER-2-) Group B: human epidermal growth factor receptor-2 overexpressing tumors (HER-2+) Group C: familial BRCA1 or BRCA2 mutation carriers

Inclusion criteria

  • Progressive metastatic breast cancer previously treated in the following subpopulation of patients: Group A: Triple negative phenotype: Estrogen Receptor, Progesterone Receptor and HER-2 negative status (surrogate of basal-like type) Group B: HER-2 overexpressing tumors. Group C: Familial BRCA1 or BRCA2 mutation carriers

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