Clinical trial · Observational
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)
NCT07828652CI-TRIAL-00126437not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| TNBC - Triple-Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Medical record use research | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- primary purpose
- timeFrame
- until 2027.12.31
- description
- Evaluate pathologic complete response, pCR,ypT0N0
Secondary outcomes (1)
- measure
- Outcome Measure
- timeFrame
- until 2027.12.31
- description
- Analysis of overall survival (OS), in real-world practice of neoadjuvant therapy including pembrolizumab in patients with triple-negative breast cancer (TNBC)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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 surgeryReferences
Publications (0)
Data not yet available
No reference posted for this study.