Breast Tumors Clinical Trial
Official title:
Phase II, Open Label Study of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC) for Advanced Breast Cancer Patients, With Biomarkers Analysis to Characterize Response/Resistance to Therapy
Multicenter, open-label phase II trial assessing the efficacy of DS-8201a monotherapy in patients with metastatic breast cancer.
The main objective is to evaluate the anti-tumor activity of DS-8201a in three cohorts of advanced breast cancer patients: - Cohort 1: HER2 over-expressing (HER2 IHC3+ or HER2 IHC2+/ISH+) - Cohort 2: HER2 low-expressing (IHC1+ or IHC2+/ISH-) - Cohort 3: HER2 non-expressing (IHC0+) ;
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