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NOT YET RECRUITING
NCT07292207
PHASE2

Abemaciclib for Molecular Residual Disease Detected by Circulating Tumor DNA in HR+/HER2- Early Breast Cancer

Sponsor: Nagoya City University

View on ClinicalTrials.gov

Summary

The goal of this clinical study is to determine whether monitoring ctDNA and treating patients who become ctDNA-positive with abemaciclib can help prevent the recurrence of hormone receptor-positive, HER2-negative breast cancer after curative surgery and standard therapy. The study will also assess the safety of abemaciclib and the medical problems that may occur during treatment. Participants will receive routine follow-up after surgery, undergo regular blood tests to measure ctDNA, and, if ctDNA becomes positive, receive abemaciclib for a defined treatment period with scheduled clinic visits for examinations and safety assessments. Researchers will evaluate recurrence-free survival, distant recurrence-free survival, adverse events, the time between ctDNA positivity and clinical recurrence, and the rate of ctDNA clearance at the end of abemaciclib therapy.

Official title: Phase 2 Study of Abemaciclib for Molecular Residual Disease Detected by Circulating Tumor DNA in HR+/HER2- Early Breast Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-01-10

Completion Date

2031-08-31

Last Updated

2025-12-18

Healthy Volunteers

No

Interventions

DRUG

Abemaciclib 150 MG Oral Tablet

Adding abemaciclib for 2-year with endcrine treatment

Locations (1)

Nagoya City University

Nagoya, Japan