Recruiting

Trastuzumab Deruxtecan

Sponsor:

Sun Yat-sen University

Code:

NCT06551220

Conditions

Metastatic Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Trastuzumab Deruxtecan

Study Details

Brief summary:

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?

Conditions

Metastatic Breast Cancer

Study ID

NCT06551220

Start date

Oct 10, 2022

Status verified date

May, 2026

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients with advanced or locally unresectable breast cancer;
  • Treated with T-DXd (DS-8201, trastuzumab deruxtecan) regardless of line of therapy, HR, and HER2 expression level;
  • HER2 immunohistochemistry staining information of the primary lesion or metastatic/recurrent lesion;
  • Measurable lesions with treatment response results that can be evaluated through imaging examinations;
  • Able to follow up with the latest progression-free survival or overall survival.

Exclusion Criteria:

  • Patients with missing basic clinical information or HER2 immunohistochemistry staining information;
  • Patients with missing pathological results for both primary and metastatic/recurrent lesions;
  • Patients with no measurable lesions and unable to evaluate T-DXd treatment response;
  • Discontinue T-DXd therapy for unacceptable adverse events or other reasons;
  • Patients lost to follow-up after T-DXd treatment.

Study Design

Enrollment

800 participants

Anticipated

Interventions and Outcome Measures

Arms

Trastuzumab Deruxtecan

Interventions

Trastuzumab Deruxtecan

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

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 and Locations

Central contacts

Xiaoming Xie, MD, PhD

86-020-87343806xiexm@sysucc.org.cn

Yutian Zou, MD, PhD

86-020-87343806zouyt@sysucc.org.cn

Locations

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Amin H. Nassar, MD

amin.nassar@yale.edu

Dana-Farber Cancer Institute, Harvard Medical School

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Paolo Tarantino, MD, PhD

Paolo_Tarantino@DFCI.HARVARD.EDU

More Information

Sponsor

Sun Yat-sen University

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • Breast Cancer
  • Trastuzumab Deruxtecan
  • HER2

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sun Yat-sen University on 2026-05-22.