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

NCT07292207 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: NCU-003-AbemaNCU
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

ctDNA Monitoring; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• ctDNA clearance rate

  The rate of change of ctDNA positive to negative during abemaciclib treatment

  Within 2 years

Secondary Outcomes (4)

• Invasive disease-free survival (IDFS)

  through study completion, an average of 3 year

• Distant recurrence-free survival (DRFS)

  through study completion, an average of 3 year

• Lead time from ctDNA positivity to clinical recurrence

  through study completion, an average of 2 year

• Incidence of adverse events

  up to 2 years

Study Arms (1)

Treatment for MRD positive

EXPERIMENTAL

ctDNA-posotive during adjuvant treatment

Drug: Abemaciclib 150 MG Oral Tablet

Interventions

Abemaciclib 150 MG Oral Tablet DRUG

Adding abemaciclib for 2-year with endcrine treatment

Treatment for MRD positive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed invasive breast cancer.
• ctDNA-positive after completion of definitive local/systemic therapy.
• Definitive breast surgery performed; axillary node status confirmed.
• HR-positive, HER2-negative disease.
• Tumor and nodal status meet predefined pathological risk criteria.
• ECOG PS 0 - 1.
• No bilateral breast cancer.
• Adequate recovery from prior therapy and acceptable organ function.
• No distant metastasis before registration.
• Appropriate contraception; informed consent obtained.

You may not qualify if:

• Active second malignancy.
• Prior CDK4/6 inhibitor use.
• Recent major surgery or active infection.
• Uncontrolled hypertension or significant cardiac disease.
• Recent thromboembolic events.
• Interstitial lung disease or active pneumonitis.
• Unrecovered toxicities from prior treatment.
• Active HIV, HBV, or HCV infection.
• Pregnancy or breastfeeding.

Sponsors & Collaborators

• Nagoya City University: lead
• Tohoku University: collaborator
• Japanese Foundation for Cancer Research: collaborator
• National Cancer Center, Japan: collaborator
• University of Tsukuba: collaborator
• Gifu University Graduate School of Medicine: collaborator
• Aichi Cancer Center: collaborator

Study Sites (1)

Nagoya City University

Nagoya, Japan

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

abemaciclib; Tablets

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Ryuta Asada, PhD

  Nagoya City University

  STUDY DIRECTOR

Central Study Contacts

Kazuki Nozawa, MD

CONTACT

+81-52-851-5511; kazuki.nozawa7@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Abemaciclib for 2-year

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: December 18, 2025
• Study Start: January 10, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): August 31, 2031
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 year after publication.
• Access Criteria: All researcher

Locations

JP (1)