Trastuzumab Emtansine(T-DM1) After Trastuzumab Deruxtecan(T-DXd) in HER2-Positive Breast Cancer in Korea

Launched by SEOUL NATIONAL UNIVERSITY HOSPITAL · Apr 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called Trastuzumab Emtansine (T-DM1) after patients have been treated with another medication called Trastuzumab Deruxtecan (T-DXd) for advanced HER2-positive breast cancer. The goal is to see how effective T-DM1 is when given right after T-DXd when the cancer progresses. This study is currently recruiting participants in Korea and is open to anyone aged 39 and older, regardless of gender.

To be eligible for this trial, patients must have advanced breast cancer that is HER2-positive and have previously received T-DXd treatment. They should intend to start T-DM1 as their next treatment after their cancer worsens following T-DXd. However, patients who have had other systemic treatments for breast cancer after T-DXd (with some exceptions) or those who have already been treated with T-DM1 for advanced breast cancer are not eligible. Participants can expect to receive regular monitoring and care throughout the study. This research could help improve treatment options for people with this type of breast cancer in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • HER2-positive, advanced (unresectable locally advanced or metastatic) breast cancer
• • Prior treatment with trastuzumab deruxtecan(T-DXd) in the advanced setting
• • Intention to treat with Trastuzumab Emtansine (T-DM1) as first therapy upon T-DXd progression
• Exclusion Criteria:
• • Any systemic treatment, other than T-DM1, for breast cancer after trastuzumab deruxtecan (As an exception, patients treated with endocrine agents, not in combination with cytotoxics or antibody-drug conjugates, will be permitted in the study)
• • Has been previously treated with T-DM1 for advanced breast cancer
• • Has been previously treated with 4 or more lines of therapy for advanced breast cancer
• • Half (50%) or more patients will be those who were treated with second-line trastuzumab deruxtecan (i.e. patients at the later line will be capped).