Abemaciclib for Molecular Residual Disease Detected by Circulating Tumor DNA in HR+/HER2- Early B… (NCT07292207) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Abemaciclib for Molecular Residual Disease Detected by Circulating Tumor DNA in HR+/HER2- Early Breast Cancer
Japan30 participantsStarted 2026-01-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.