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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNagoya City University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Abemaciclib 150 MG Oral Tablet

    Drug

    Adding abemaciclib for 2-year with endcrine treatment

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Treatment for MRD positiveExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ctDNA clearance rate

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

Time frame
Within 2 years

Secondary outcomes

1

Invasive disease-free survival (IDFS)

A measure of the time from study enrollment until any invasive recurrence, second primary cancer, or death occurs.

Time frame
through study completion, an average of 3 year
2

Distant recurrence-free survival (DRFS)

The time from study enrollment to the development of distant metastatic recurrence or death.

Time frame
through study completion, an average of 3 year
3

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.

Time frame
through study completion, an average of 2 year
4

Incidence of adverse events

Time frame
up to 2 years

Other outcomes

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

This trial is not recruiting at the moment. You can still explore other options: