triple negaive breast cancer breast cancer, pembrolizumab
Conditions
Interventions
Two cycles of dose dense EC are administered as preoperative chemotherapy, and tumor size is measured by MRI.
If the tumor size has decreased by 40% or less, patients are treated with EC plus pembroli
pembrolizumab
pembrolizumab, de-escalation
Sponsors
Kuba Sayaka
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients diagnosed with invasive breast cancer by needle biopsy or tissue biopsy 2) Stage II patients with tumor diameter less than 3 cm 3) Patients with ER-negative, PgR-negative, HER2-negative breast cancer 4) Patients who can undergo mammography MRI 5) Patients who have not received prior breast cancer chemotherapy 6) Patients who are between 60 and 75 years of age at the time consent is obtained 7) Patients who have given written consent to participate in the study
Exclusion criteria
Exclusion criteria: 1) Patients with multiple lesions 2) Patients with metastatic or recurrent breast cancer 3) Pregnant women and those who may be pregnant or nursing 4) Patients with contraindications to pembrolizumab treatment 5) Patients deemed inappropriate for inclusion in the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR rate and incidence of adverse events including irAE in all patients (CTCAE ver. 5.0) | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of responder group and no-pCR cases among all patients, 3-year recurrence-free survival (all patients, pCR group, no-pCR group), proportion of responder group, pathologic response (grade) in responder, re- search for cut-off value, and incidence of Grade 3 or higher adverse events, incidence of irAEs, completion rate of chemotherapy | — |
Contacts
Public ContactSayaka Kuba
Nagasaki University Hospital
Outcome results
None listed