Efficacy of Trastuzumab Deruxtecan in Metastatic Breast Cancer With Different HER2 Expression Patterns
Part of paid clinical trials in New Haven, Connecticut.
- Sponsor
- Sun Yat-sen University
- Study ID
- NCT06551220
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Trastuzumab Deruxtecan — DRUGThe patients received Trastuzumab Deruxtecan at a dose of 5.4 mg/kg every 3 weeks until disease progression or unacceptable adverse effects occurred.
Study Details
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?
Key Dates
- Start date
- Oct 10, 2022
- Status verified
- May 2026
- Primary completion
- Jul 31, 2026
- Completion
- Jul 31, 2026
Study Design
- Enrollment
- 800 participants (estimated)
Arms
- Arm: Trastuzumab Deruxtecan
Primary Outcome Measure
Progression-free survival (PFS) [ Time Frame: 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. ]
Central Contacts
- Xiaoming Xie, MD, PhD86-020-87343806
- Yutian Zou, MD, PhD86-020-87343806
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Yale Cancer Center | New Haven | Connecticut | 06510 | Amin H. Nassar, MD |
| Dana-Farber Cancer Institute, Harvard Medical School | Boston | Massachusetts | 02215 | Paolo Tarantino, MD, PhD |
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