Real-world Treatment Outcomes and Safety of Neoadjuvant Pembrolizumab-containing Therapy in Patients With Triple-negative Breast Cancer: Korean Nationwide Multicenter Study (Pembro-Real World)

N/ANot Yet RecruitingNCT07828652

Yeon Hee Park2,000 enrolled

Overview

The purpose of this study is to evaluate the treatment outcomes and safety of neoadjuvant therapy including pembrolizumab in real-world practice for patients with triple-negative breast cancer (TNBC) in a multi-center study in Korea. In particular, we aim to evaluate the treatment efficacy focusing on the pathologic complete response (pCR) and analyze the association with recurrence rates and survival indicators.

There is a need for research analyzing treatment response, long-term clinical outcomes, and the patterns of short- and long-term immune-related adverse events in TNBC patients who have received neoadjuvant chemotherapy including pembrolizumab in a real-world clinical setting. This study aims to provide real-world evidence by comprehensively analyzing pathological response, recurrence patterns, survival outcomes, and treatment-related adverse events in TNBC patients who received pembrolizumab-based neoadjuvant chemotherapy in actual clinical practice. These findings are expected to provide important evidence for validating clinical trial results in real-world clinical settings and optimizing future treatment strategies for TNBC patients.

Study Type

OBSERVATIONAL

Enrollment

2,000

Conditions

TNBC - Triple-Negative Breast Cancer

Interventions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Age of 19 years or older at the start of treatment * Patients diagnosed with triple-negative breast cancer (TNBC) pathologically * Patients diagnosed with clinical stage II or III ④ Patients who started neoadjuvant chemotherapy including pembrolizumab, paclitaxel, carboplatin, doxorubicin, and cyclophosphamide as preoperative neoadjuvant chemotherapy after July 2022 Exclusion Criteria: * History of other invasive malignancies, either concurrently or in the past (except for cancers where at least 5 years have passed since completion of treatment and there has been no recurrence) ② Patients diagnosed with clinical stage II or III who have a history of previous diagnosis and treatment for invasive breast cancer and have experienced local recurrence * Patients who have not started pembrolizumab treatment concurrently with chemotherapy ④ Cases where assessment of pathological response is impossible due to the absence of surgery

Outcomes

Primary Outcomes

primary purpose

Evaluate pathologic complete response, pCR,ypT0N0

Time frame: until 2027.12.31

Secondary Outcomes

Outcome Measure

Analysis of overall survival (OS), in real-world practice of neoadjuvant therapy including pembrolizumab in patients with triple-negative breast cancer (TNBC)