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)

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorYeon Hee Park

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Retrospective

Treatments tested in this trial

  • Medical record use research

    Other intervention

    Medical record use research

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

primary purpose

Evaluate pathologic complete response, pCR,ypT0N0

Time frame
until 2027.12.31

Secondary outcomes

1

Outcome Measure

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

Time frame
until 2027.12.31

Other outcomes

1

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)

Time frame
Until 2027.12.31
2

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)

Time frame
until 2027.12.31

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yeon Hee Park

Lead sponsor

Samsung Medical Center

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: