Breast Cancer early breast cancer
Conditions
Interventions
Abemaciclib for 2-year
C000590451
abemaciclib
Sponsors
Nozawa Kazuki
Nagoya City University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed invasive breast cancer. 2.ctDNA-positive after completion of definitive local/systemic therapy. 3.Definitive breast surgery performed; axillary node status confirmed. 4.HR-positive, HER2-negative disease. 5.Tumor and nodal status meet predefined pathological risk criteria. 6.ECOG PS 0 - 1. 7.No bilateral breast cancer.
Exclusion criteria
Exclusion criteria: 1.Active double cancer, except for completely resected or long-term disease-free cases. 2.Prior use of CDK4/6 inhibitors. 3.Major surgery within 14 days before registration. 4.Active infection requiring systemic therapy. 5.Active gastrointestinal ulcer. 6.Poorly controlled hypertension despite adequate medications. 7.Symptomatic heart failure, unstable angina, or clinically significant arrhythmias. 8.Myocardial infarction within the past year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ctDNA clearance rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Invasive disease free survival rate 2.Distant recurrence free survival rate 3.Incidence of adverse events 4.Lead time from ctDNA positivity to clinical recurrence 5.ctDNA clearance rate (at completion of abemaciclib therapy) | — |
Contacts
Public ContactKazuki Nozawa
Nagoya City University
Outcome results
None listed