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

HER2 Heterogeneity and Its Impact on Benefit From Trastuzumab Deruxtecan in Metastatic Breast Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how well trastuzumab deruxtecan (T-DXd) works for breast cancer that has spread. It asks whether differences in the amount and location of HER2, a protein in cancer tissue, affect treatment benefit. It is for people treated with T-DXd who have advanced breast cancer or breast cancer that cannot be removed with surgery.

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?

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have advanced breast cancer or breast cancer that cannot be removed with surgery.
  • Have been treated with T-DXd, no matter how many other treatments you have had or your hormone receptor or HER2 levels.
  • Have HER2 staining test results from the original cancer or cancer that spread or came back.
  • Have tumors that can be measured on scans, with results showing how they responded to treatment.
  • Have follow-up information on how long you lived or how long you lived without the cancer getting worse.

Who can't join

  • Are missing basic medical information or HER2 staining test results.
  • Have no tissue test results from either the original cancer or cancer that spread or came back.
  • Have no tumors that can be measured and cannot have the response to T-DXd checked.
  • Stopped T-DXd because of side effects that could not be tolerated or for other reasons.
  • Could not be reached for follow-up after T-DXd treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (2)

CT

MA