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

Sponsor
MedSIR
Study ID
NCT04420598
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab deruxtecan — DRUG
    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

Study Details

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

Key Dates

Start date
May 25, 2020
Status verified
Jun 2025
Primary completion
Sep 30, 2021
Completion
Apr 4, 2023

Study Design

Enrollment
41 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Trastuzumab deruxtecan (DS-8201a)
    * 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.

Primary Outcome Measure

16 Weeks PFS Per Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) (Cohort 1) [ Time Frame: From baseline up to 16 weeks ]

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