Clinical trial · Interventional
Abemaciclib for Molecular Residual Disease Detected by Circulating Tumor DNA in HR+/HER2- Early Breast Cancer
Phase 2 Study of Abemaciclib for Molecular Residual Disease Detected by Circulating Tumor DNA in HR+/HER2- Early Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| ctDNA Monitoring | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abemaciclib 150 MG Oral Tablet | Drug | Abemaciclib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment for MRD positive
- description
- ctDNA-posotive during adjuvant treatment
- interventionNames
- Drug: Abemaciclib 150 MG Oral Tablet
Primary outcomes (1)
- measure
- ctDNA clearance rate
- timeFrame
- Within 2 years
- description
- The rate of change of ctDNA positive to negative during abemaciclib treatment
Secondary outcomes (4)
- measure
- Invasive disease-free survival (IDFS)
- timeFrame
- through study completion, an average of 3 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available