About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
about 2000 population with TNBC
Trial design
Other
Retrospective
Treatments tested in this trial
Medical record use research
Other interventionMedical record use research
Treatment groups
Trial outcomes
Primary outcomes
primary purpose
Evaluate pathologic complete response, pCR,ypT0N0
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)
Other outcomes
Other Outcome Measure
Analysis of event-free survival in real-world practice of neoadjuvant therapy including pembrolizumab in patients with triple-negative breast cancer (TNBC)
Other Outcome Measure
Analysis of adverse events, etc., in real-world practice of neoadjuvant therapy including pembrolizumab in patients with triple-negative breast cancer (TNBC)
Locations
Sponsors and contacts
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Yeon Hee Park
Lead sponsor
Samsung Medical Center
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options: