About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Active second malignancy.
Prior CDK4/6 inhibitor use.
Recent major surgery or active infection.
Uncontrolled hypertension or significant cardiac disease.
Trial design
Single group
Treatments tested in this trial
Abemaciclib 150 MG Oral Tablet
DrugAdding abemaciclib for 2-year with endcrine treatment
Treatment groups
Trial outcomes
Primary outcomes
ctDNA clearance rate
The rate of change of ctDNA positive to negative during abemaciclib treatment
Secondary outcomes
Invasive disease-free survival (IDFS)
A measure of the time from study enrollment until any invasive recurrence, second primary cancer, or death occurs.
Distant recurrence-free survival (DRFS)
The time from study enrollment to the development of distant metastatic recurrence or death.
Lead time from ctDNA positivity to clinical recurrence
The interval between the first detection of ctDNA positivity and the confirmed clinical or radiologic recurrence of cancer.
Incidence of adverse events
Sponsors and contacts
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Nagoya City University
Lead sponsor
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
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