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NCT07292207: ARCHE

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

Not yet recruiting Phase 2 Last updated 18 December 2025
What this trial tests

Phase 2 trial testing Abemaciclib 150 MG Oral Tablet in ctDNA Monitoring in 30 participants. Not yet recruiting.

Timeline
10 January 2026
Primary endpoint
30 November 2028
31 August 2031

Quick facts

Lead sponsorNagoya City University
PhasePhase 2
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment30
Start date10 January 2026
Primary completion30 November 2028
Estimated completion31 August 2031
Sites1 location across Japan

Drugs / interventions tested

Conditions studied

Sponsor

Nagoya City University

Who can join

18 and older, any sex, with ctDNA Monitoring or Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for ctDNA Monitoring

Currently open trials in the same condition.

Other Nagoya City University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07292207.

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