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

NCT07292207 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Abemaciclib 150 MG Oral Tablet

Adding abemaciclib for 2-year with endcrine treatment

Sponsors & Collaborators

  • Tohoku University

    collaborator OTHER

  • Japanese Foundation for Cancer Research

    collaborator OTHER

  • National Cancer Center, Japan

    collaborator OTHER_GOV

  • University of Tsukuba

    collaborator OTHER

  • Gifu University Graduate School of Medicine

    collaborator OTHER

  • Aichi Cancer Center

    collaborator OTHER

  • Nagoya City University

    lead OTHER

Principal Investigators

  • Ryuta Asada, PhD · Nagoya City University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-10
Primary Completion
2028-11-30
Completion
2031-08-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07292207 on ClinicalTrials.gov