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)

NCT07828652 | Not Yet Recruiting

• 1 other identifier: 2026-08-063
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

TNBC - Triple-Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• primary purpose

  Evaluate pathologic complete response, pCR,ypT0N0

  until 2027.12.31

Secondary Outcomes (1)

• Outcome Measure

  until 2027.12.31

Other Outcomes (2)

• Other Outcome Measure

  Until 2027.12.31

• Other Outcome Measure

  until 2027.12.31

Interventions

Medical record use research OTHER

Medical record use research

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

about 2000 population with TNBC

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yeon Hee Park: lead

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Yeon hee Park, MD,phD

CONTACT

82-10-9933-1780; yoenh.park@samsung.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 18, 2026
• Study Start: September 14, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 18, 2026

Record last verified: 2026-09