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

Running, not enrolling

Conditions studied: Breast Cancer, Metastatic, HER2 + Breast Cancer

In brief

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 facts

Study ID

NCT06663787

Run by

Nagoya City University

People needed

50

Starts

2024-04-01

Expected to finish

2026-12-31

Last updated by the study team

2026-05-13

Who can join

Age: 20 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• HER2 + metastatic breast cancer
• Pre / post menopausal
• Previously treated with anti-HER2 therapy
• Continuing CR or PR for more than 2 year

You may not qualify if…

• Patients who were deemed inappropriate as research subjects based on the physician's judgment, such as those possibly receiving inappropriate treatment.

Where it is running

• 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

Full record on ClinicalTrials.gov

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