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Observational Study of Trastuzumab Deruxtecan in Metastatic Breast Cancer

This observational study is looking at how well the drug Trastuzumab Deruxtecan works for women with metastatic breast cancer (cancer that has spread from its original site). Researchers want to understand if differences in HER2 (a protein found on some cancer cells) levels and how it's spread in different tissues affect how well Trastuzumab Deruxtecan works. You may be eligible if you are a woman between 18 and 80 years old, have advanced or locally unresectable breast cancer, and have been treated with Trastuzumab Deruxtecan. The main goal is to see how long people live without their cancer getting worse (progression-free survival). The current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will collect information from 800 participants who are already receiving Trastuzumab Deruxtecan. It is not a randomized study where participants are assigned to different treatment groups.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from the start of Trastuzumab Deruxtecan treatment until their disease progresses or they pass away, for up to 60 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06551220

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

Recruiting
Not specifiedAges 18–80Observational
Sun Yat-sen University
~800 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:Trastuzumab Deruxtecan

At a glance

Recruiting sites
26 of 26 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival (PFS)
Measured over 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.

Conditions

Metastatic Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

26 sites across 9 states
Guangdong15
Hunan4
Connecticut1
Massachusetts1
Fujian1
Inner Mongolia1
Jiangsu1
Shanghai Municipality1

Study leadership

  • Xiaoming Xie, MD, PhD · PRINCIPAL_INVESTIGATOR · Sun Yat-Sen University Cancer Center

Who to contact

Xiaoming Xie, MD, PhD
[email protected]
86-020-87343806
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Progression-free survival (PFS)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.

    Progression-free survival (PFS) is defined as the time from T-DXd treatment initiation to disease progression or death from any cause.