A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
AstraZeneca
Study ID
NCT04739761
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab Deruxtecan — DRUG
    Participants will receive T-DXd administered using an IV bag containing 5% (w/v) dextrose injection infusion solution.

Study Details

This is open-label, multicenter, international study, assessing the efficacy and safety of Trastuzumab deruxtecan (T-DXd) in participants with or without brain metastasis (BMs), with previously-treated advanced/metastatic HER2-positive breast cancer whose disease has progressed on prior anti-HER2-based regimens and who received no more than 2 lines/regimens of therapy in the metastatic setting (excluding tucatinib).

Key Dates

Start date
Jun 22, 2021
Status verified
Apr 2026
Primary completion
Feb 8, 2024
Completion
May 26, 2027

Study Design

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

Arms

  • Experimental: Trastuzumab Deruxtecan
    Participants with or without BM at baseline will receive intravenous (IV) T-DXd, 5.4 mg/kg, every 3 weeks (21-day cycle) until Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) defined radiological progression outside central nervous system, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation is met.

Primary Outcome Measure

Objective Response Rate (ORR) in Cohort 1 (Participants Without Brain Metastasis at Baseline) [ Time Frame: From first dose (Day 1) to progression of disease (up to 2 years 7 months) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Research SiteBostonMassachusetts02215-
Research SiteDurhamNorth Carolina27710-

Related coverage on Hipa.ai

Find similar trials in Boston, MA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Research Site· Boston, MAResearch Site· Durham, NC

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