Evaluating trastuzumab deruxtecan in metastatic breast cancer with varying HER2 levels

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate how different patterns of HER2 expression in metastatic breast cancer affect the efficacy of trastuzumab deruxtecan. It focuses on understanding the heterogeneity of HER2 levels and their spatial distribution in tissues. The study will include patients who have received trastuzumab deruxtecan and will evaluate their treatment responses through imaging examinations. The goal is to determine if these variations in HER2 expression influence patient outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Yale Cancer Center
  New Haven, Connecticut, United States Recruiting
• Dana-Farber Cancer Institute, Harvard Medical School
  Boston, Massachusetts, United States Recruiting
• Fujian Cancer Hospital, Fujian Medical University
  Fuzhou, Fujian, China Recruiting
• The 10th Affiliated Hospital of Southern Medical University
  Dongguan, Guangdong, China Recruiting
• The First People's Hospital of Foshan
  Foshan, Guangdong, China Recruiting
• The Sixth Affiliated Hospital, School of Medicine, South China University of Technology.
  Foshan, Guangdong, China Recruiting

Study contacts

• Principal investigator: Xiaoming Xie, MD, PhD — Sun Yat-Sen University Cancer Center
• Study coordinator: Xiaoming Xie, MD, PhD
• Email: xiexm@sysucc.org.cn
• Phone: 86-020-87343806

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.