DS-8201a for trEatment of aBc, BRain Mets, And Her2[+] Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
Summary
- Conditions
- Advanced Breast Cancer
- Brain Metastases
- HER2 Positive Breast Cancer
- Leptomeningeal Metastasis
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: This is a multicenter, international, open-label, single-arm, multicohort, two-stage optimal Simon's design, phase II clinical trial. After confirmed eligibility, patients will be assigned to one of the following five study cohorts: Cohort 1: HER2-positive BC with non-progressing BM (after WBRT and/or SRS and or surgery.); Cohort 2: HER2-positive or HER2-low BC with asymptomatic untreated BM; Cohort 3: HER2-positive BC with progressing BMs after local treatment; Cohort 4: HER2-low expressing BC with progressing BMs after local treatment; Cohort 5: HER2-positive or HER2-low expressing BC with LMC Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Pretreated, unresectable locally advanced or metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-positive or HER2-low expressing breast cancer (BC) with untreated or treated brain metastases (BMs) or leptomeningeal carcinomatosis (LMC).
Pretreated, unresectable locally advanced or metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-positive or HER2-low expressing breast cancer (BC) with untreated or treated brain metastases (BMs) or leptomeningeal carcinomatosis (LMC).
Tracking Information
- NCT #
- NCT04420598
- Collaborators
- Daiichi Sankyo, Inc.
- Investigators
- Principal Investigator: Marta Vaz Batista, MD MedSIR
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