Active — Not RecruitingNot Applicable

Personalized Detection of ctDNA for Patients With HER2-Positive Metastatic Breast Cancer Who Achieved Durable Response by Anti-HER2 Treatment (HER2 CR)

United States, Japan50 participantsStarted 2024-04-01

Plain-language 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.

Who can participate

Age range20 Years

SexFEMALE

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Inclusion Criteria: * HER2 + metastatic breast cancer * Pre / post menopausal * Previously treated with anti-HER2 therapy * Continuing CR or PR for more than 2 year Exclusion Criteria: * Patients who were deemed inappropriate as research subjects based on the physician's judgment, such as those possibly receiving inappropriate treatment.

What they're measuring

The status of ctDNA

Timeframe: 1 year

Trial details

NCT IDNCT06663787

SponsorNagoya City University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12-31

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