An observational study in TNBC - Triple-Negative Breast Cancer, sponsored by Yeon Hee Park. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Yeon Hee Park · Observational
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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.
1,219 studies on the registry are indexed under Triple Negative Breast Neoplasms; 445 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 193 across 106 observational studies indexed under Triple Negative Breast Neoplasms.
Browse Triple Negative Breast Neoplasms studies →Yeon Hee Park is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
about 2000 population with TNBC
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age of 19 years or older at the start of treatment
Patients diagnosed with triple-negative breast cancer (TNBC) pathologically
Exclusion Criteria:
History of other invasive , 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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Medical record use research
This study also gives Pembrolizumab. No intervention listed here names it: that was found by reading the record.
primary purpose
Evaluate pathologic complete response, pCR,ypT0N0
Time frame: until 2027.12.31
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 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
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
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Dec 2027, 15 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Triple Negative Breast Neoplasms →
Yeon Hee Park