Clinical Trial

Personalized Detection of ctDNA for Patients With HER2-Positive Metastatic Breast Cancer Patients Who Achieved Durable Response to Anti-HER2 Treatment

Study acronym: HER2 CR
Active, Not Recruiting
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-10-25; most recent amendment 2026-05-11.
Status change: Enrolling by Invitation → Active, Not Recruiting 2025-11-22
Trial Details
NCT Number NCT06663787
Lead Sponsor Nagoya City University
Conditions Breast Cancer, Metastatic, HER2 + Breast Cancer
Enrollment 50 participants
Start Date 2024-04-01
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-13