A Real-world Clinical Study of T-DXd for the Treatment of Chinese Patients With HER2 Overexpressing and HER2 Underexpressing Advanced Breast Cancer

Launched by TIANJIN MEDICAL UNIVERSITY CANCER INSTITUTE AND HOSPITAL · Jun 23, 2025

Keywords

ClinConnect Summary

This clinical study is looking at how well and how safely a medicine called T-DXd (also known as DS8201) works in treating Chinese women with advanced breast cancer that either has high or low levels of a protein called HER2. HER2 can affect how breast cancer grows, and this study includes two groups: one with higher HER2 levels and one with lower levels. The goal is to see how patients respond to this treatment in real-world medical settings, meaning doctors will use their usual care practices while collecting information about the treatment’s effects.

Women aged 18 and older with advanced breast cancer that cannot be removed by surgery or has spread to other parts of the body may be eligible. To join, patients need to have measurable cancer spots and must have already started treatment with T-DXd within the last two months. The study doesn’t change the treatment given by doctors—it simply observes and records how patients do with this medicine. Participants can expect regular check-ups, scans to measure tumor size, and monitoring for any side effects. This study aims to help doctors better understand how T-DXd works in everyday care for women with different levels of HER2 in their advanced breast cancer.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Must be competent and able to sign and date an Institutional Review Board (IRB) or Ethics Committee (EC)-approved ICF prior to any study-specific procedure or trial.
• • 2. Female patients aged ≥18 years with advanced breast cancer who are adults.
• 3. Pathologically confirmed breast cancer that meets the following criteria:
• • 1. unresectable or metastatic, with evidence of recurrent or metastatic disease.
• • 2. HER2 overexpression, or HER2 hyperexpression as determined by the central laboratory in accordance with the American Society of Clinical Oncology-Society of American Pathologists guidelines.
• • 4. Patients must have measurable lesions according to RECIST 1.1 criteria.
• • 5. Unmenopausal, menopausal, and perimenopausal female patients were allowed to be enrolled.
• • 6. Prior antitumor therapy against recurrent metastatic disease is allowed.
• Exclusion Criteria:
• • 1. Early stage breast cancer
• • 2. Patients who do not meet the criteria for HER2 overexpression and HER2 underexpression.
• • 3. Female patients during pregnancy or lactation.
• • 4. Patients deemed unsuitable for enrollment by the investigator.