Efficacy of Trastuzumab Deruxtecan in Metastatic Breast Cancer With Different HER2 Expression Patterns

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Sun Yat-sen University
Study ID
NCT06551220
Status
Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab Deruxtecan — DRUG
    The patients received Trastuzumab Deruxtecan at a dose of 5.4 mg/kg every 3 weeks until disease progression or unacceptable adverse effects occurred.

Study Details

The purpose of this observational study is to learn about the HER2 heterogeneity and its impact on benefit from trastuzumab deruxtecan in metastatic breast cancer. The main question it aims to answer is: \- Does the heterogeneity of HER2 expression level and spatial distribution in different tissues affect the efficacy of trastuzumab deruxtecan in metastatic breast cancer?

Key Dates

Start date
Oct 10, 2022
Status verified
May 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
800 participants (estimated)

Arms

  • Arm: Trastuzumab Deruxtecan

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: From date of T-DXd treatment initiation until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 60 months. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Yale Cancer CenterNew HavenConnecticut06510
Amin H. Nassar, MD
Dana-Farber Cancer Institute, Harvard Medical SchoolBostonMassachusetts02215
Paolo Tarantino, MD, PhD

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