Pembrolizumab In Older patients with triple-Negative breast cancer for Evaluating Response-guided treatment

JRCT ID: jRCT1071240119

Registered date:28/02/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: triple negaive breast cancer
• Date of first enrollment: 28/02/2025
• Target sample size: 40
• Study type: Interventional

Intervention(s)

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 pembrolizumab, carboplatin, and paclitaxel. If tumor size is smaller than 40%, continue dose-dense chemotherapy.

Outcome(s)

• Primary Outcome: pCR rate and incidence of adverse events including irAE in all patients (CTCAE ver. 5.0)
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 60age old
• Age maximum: <= 75age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kuba Sayaka