NCT04420598

DS-8201a for trEatment of aBc, BRain Mets, And Her2[+] Disease

Multicenter, Open-Label, Single-Arm, Multicohort Phase II Clinical Trial of Trastuzumab Deruxtecan(DS-8201a) in Human Epidermal Growth Factor Receptor 2 HER2+ Advanced Breast Cancer With Brain Metastases and/or Leptomeningeal Carcinomatosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: MedSIR · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, international, open-label, single-arm, multicohort, two-stage optimal Simon's design, phase II clinical trial

Detailed 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).

Conditions

• Advanced Breast Cancer
• HER2-positive Breast Cancer
• Brain Metastases
• Leptomeningeal Metastasis

Interventions

Type	Name	Description
DRUG	Trastuzumab deruxtecan	After having confirmed eligibility and entered into the clinical trial, patients will be treated with trastuzumab deruxtecan (DS-8201a) at 5.4 mg/Kg administered as an intravenous (IV) infusion on Day of 21-day cycle (Q3W), initially for at least 90 minutes, then, if there is no infusion-related reaction, for a minimum of 30 minutes. In patients with hormone receptor (HR)-positive status (estrogen receptor \[ER\] and/or progesterone receptor \[PgR\]) administration of endocrine therapy is not allowed. In patients allocated in study cohort 5, administration of intrathecal therapy is not allowed

Timeline

• Start date: 2020-05-25
• Primary completion: 2021-09-30
• Completion: 2023-04-04
• First posted: 2020-06-09
• Last updated: 2025-06-24
• Results posted: 2025-06-24

Locations

16 sites across 2 countries: Portugal, Spain