ctDNA MonitoringPhase 2ARCHENCT07292207
Abemaciclib for Molecular Residual Disease Detected by Circulating Tumor DNA in HR+/HER2- Early Breast Cancer
A Phase 2 study testing Abemaciclib 150 MG Oral Tablet in people with ctDNA Monitoring and Breast Cancer, run by Nagoya City University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ctDNA Monitoring, Breast Cancer
- What is being tested?
- Abemaciclib 150 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteJapan
- Study dates
- 10 Jan 2026to 31 Aug 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- No bilateral breast cancer.
- Adequate recovery from prior therapy and acceptable organ function.
- No distant metastasis before registration.
- Appropriate contraception; informed consent obtained.
Who cannot join
- 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.
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- Unrecovered toxicities from prior treatment.
- Active HIV, HBV, or HCV infection.
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site
Nagoya City University
Nagoya
Kazuki Nozawa, MD, +81-52-851-5511, ncu-003@med.nagoya-cu.ac.jp
About this study
Official title: Phase 2 Study of Abemaciclib for Molecular Residual Disease Detected by Circulating Tumor DNA in HR+/HER2- Early Breast Cancer
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.
Read the detailed description
The purpose of this clinical study is to investigate whether identifying molecular relapse through ctDNA monitoring and initiating abemaciclib treatment at the time of ctDNA positivity can reduce the risk of recurrence in patients with hormone receptor-positive, HER2-negative early breast cancer who have completed curative surgery and standard adjuvant therapy. The study also aims to evaluate the safety profile of abemaciclib in this early-stage setting and to clarify how patients tolerate the treatment over time. Participants will undergo routine postoperative surveillance, including scheduled imaging and laboratory testing, as well as regular blood sampling for ctDNA analysis. When ctDNA becomes detectable, indicating minimal residual disease, participants will begin a predefined course of abemaciclib and attend clinic visits at regular intervals for physical examinations, toxicity assessments, and laboratory monitoring.
In addition to determining whether early intervention with abemaciclib can delay or prevent clinical recurrence, researchers will examine several key outcomes. These include invasive disease-free survival, distant recurrence-free survival, and the incidence of adverse events throughout the treatment period. The study will also measure the "lead time" between ctDNA positivity and radiologic or clinical recurrence, which may provide insight into the biological dynamics of disease relapse. Furthermore, researchers will evaluate ctDNA clearance at the completion of abemaciclib therapy, as ctDNA clearance may serve as an early indicator of treatment efficacy. Collectively, these results are expected to clarify the clinical utility of ctDNA-guided therapy escalation and to inform future strategies for preventing recurrence in early breast cancer.
- Conditions
- ctDNA Monitoring, Breast Cancer
- Being tested
- Abemaciclib 150 MG Oral Tablet
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abemaciclib 150 MG Oral TabletDrug
Adding abemaciclib for 2-year with endcrine treatment
| Study group | Role | What they receive |
|---|---|---|
| Treatment for MRD positive | Experimental | ctDNA-posotive during adjuvant treatment Receives: Drug: Abemaciclib 150 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
ctDNA clearance rate
The rate of change of ctDNA positive to negative during abemaciclib treatment
Measured: Within 2 years
Secondary outcomes (4)
Invasive disease-free survival (IDFS)
A measure of the time from study enrollment until any invasive recurrence, second primary cancer, or death occurs.
Measured: through study completion, an average of 3 year
Distant recurrence-free survival (DRFS)
The time from study enrollment to the development of distant metastatic recurrence or death.
Measured: through study completion, an average of 3 year
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.
Measured: through study completion, an average of 2 year
Incidence of adverse events
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start10 Jan 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion31 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ctDNA MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Abemaciclib for 2-year
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nagoya City University
- Sponsor type
- University, hospital or other
- Collaborators
- Tohoku University, Japanese Foundation for Cancer Research, National Cancer Center, Japan, University of Tsukuba, Gifu University Graduate School of Medicine, Aichi Cancer Center
- Responsible party
- Principal investigator, Kazuki Nozawa, Nagoya City University
- Investigators
- Ryuta Asada, PhD, Study director, Nagoya City University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292207
- Sponsor's protocol ID
- NCU-003-Abema
- Other IDs
- NCU
- Acronym
- ARCHE
- Status last verified
- Dec 2025
- First submitted
- 22 Nov 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: only IPD used in the results publication
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Abemaciclib for Molecular Residual Disease Detected by Circulating Tumor DNA in HR+/HER2- Early Breast Cancer
- ClinicalTrials.gov ID
- NCT07292207
- Acronym / sponsor ID
- ARCHE / NCU-003-Abema
- Conditions
- ctDNA Monitoring, Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nagoya City UniversityUniversity, hospital or other
- Collaborators
- Tohoku University, Japanese Foundation for Cancer Research, National Cancer Center, Japan, University of Tsukuba, Gifu University Graduate School of Medicine, Aichi Cancer Center
- Study start
- 10 Jan 2026 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 31 Aug 2031 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this clinical study is to investigate whether identifying molecular relapse through ctDNA monitoring and initiating abemaciclib treatment at the time of ctDNA positivity can reduce the risk of recurrence in patients with hormone receptor-positive, HER2-negative early breast cancer who have completed curative surgery and standard adjuvant therapy. The study also aims to evaluate the safety profile of abemaciclib in this early-stage setting and to clarify how patients tolerate the treatment over time. Participants will undergo routine postoperative surveillance, including scheduled imaging and laboratory testing, as well as regular blood sampling for ctDNA analysis. When ctDNA becomes detectable, indicating minimal residual disease, participants will begin a predefined course of abemaciclib and attend clinic visits at regular intervals for physical examinations, toxicity assessments, and laboratory monitoring.
In addition to determining whether early intervention with abemaciclib can delay or prevent clinical recurrence, researchers will examine several key outcomes. These include invasive disease-free survival, distant recurrence-free survival, and the incidence of adverse events throughout the treatment period. The study will also measure the "lead time" between ctDNA positivity and radiologic or clinical recurrence, which may provide insight into the biological dynamics of disease relapse. Furthermore, researchers will evaluate ctDNA clearance at the completion of abemaciclib therapy, as ctDNA clearance may serve as an early indicator of treatment efficacy. Collectively, these results are expected to clarify the clinical utility of ctDNA-guided therapy escalation and to inform future strategies for preventing recurrence in early breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Abemaciclib for 2-year
| Arm | Type | Receives |
|---|---|---|
| Treatment for MRD positive | Experimental | Drug: Abemaciclib 150 MG Oral TabletctDNA-posotive during adjuvant treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (9 listed)
- Active second malignancy.
- Prior CDK4/6 inhibitor use.
- Recent major surgery or active infection.
- Uncontrolled hypertension or significant cardiac disease.
- Recent thromboembolic events.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abemaciclib 150 MG Oral TabletAdding abemaciclib for 2-year with endcrine treatment | Drug | Treatment for MRD positive |
Primary outcome
ctDNA clearance rate
Time frame: Within 2 years
The rate of change of ctDNA positive to negative during abemaciclib treatment
4 secondary outcomes
Invasive disease-free survival (IDFS)
Time frame: through study completion, an average of 3 year
Distant recurrence-free survival (DRFS)
Time frame: through study completion, an average of 3 year
Lead time from ctDNA positivity to clinical recurrence
Time frame: through study completion, an average of 2 year
Incidence of adverse events
Time frame: up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: Yes. only IPD used in the results publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ryuta Asada, PhD study director
Nagoya City University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Abemaciclib 150 MG Oral Tablet in people with ctDNA Monitoring and Breast Cancer, run by Nagoya City University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kazuki Nozawa, MD (+81-52-851-5511, kazuki.nozawa7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ctDNA clearance rate (time frame: Within 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.