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Personalized Detection of ctDNA for Patients With HER2-Positive Metastatic Breast Cancer Who Achieved Durable Response by Anti-HER2 Treatment (HER2 CR)
Sponsor: Nagoya City University
Summary
Anti-HER2 therapy, such as trastuzumab and pertuzumab, has significantly improved long-term survival in HER2-positive breast cancer. The updated data of the CLEOPATRA trial showed significant Kaplan-Meier curves, suggesting the potential for a cure. However, the efficacy of maintenance therapy in long-term responders remains unexplored. This study will assess MRD in unresectable HER2-positive breast cancer cases with long-term response using the Signatera™ ctDNA assay, which could contribute to future treatment strategy development.
Key Details
Gender
FEMALE
Age Range
20 Years - Any
Study Type
OBSERVATIONAL
Enrollment
50
Start Date
2024-04-01
Completion Date
2025-12-31
Last Updated
2025-11-28
Healthy Volunteers
No
Interventions
Trastuzumab (Herceptin)
Continuing anti-HER2 treatment
SIgnatera
A personalized, tumor-informed test.
Locations (4)
Natera
San Carlos, Texas, United States
Aichi Cancer Center
Nagoya, Aichi-ken, Japan
Nagoya City University
Nagoya, Aichi-ken, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Tokyo, Tokyo, Japan