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Purpose

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?

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Arm Groups

ArmDescriptionAssigned Intervention
Trastuzumab Deruxtecan
  • Drug: 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.

Recruiting Locations

Yale Cancer Center
New Haven, Connecticut 06510
Contact:
Amin H. Nassar, MD
amin.nassar@yale.edu

Dana-Farber Cancer Institute, Harvard Medical School
Boston, Massachusetts 02215
Contact:
Paolo Tarantino, MD, PhD
Paolo_Tarantino@DFCI.HARVARD.EDU

More Details

NCT ID
NCT06551220
Status
Recruiting
Sponsor
Sun Yat-sen University

Study Contact

Xiaoming Xie, MD, PhD
86-020-87343806
xiexm@sysucc.org.cn

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center