TNBC - Triple-Negative Breast CancerNCT07828652
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)
An observational study of TNBC - Triple-Negative Breast Cancer, run by Yeon Hee Park.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- TNBC - Triple-Negative Breast Cancer
- What is being tested?
- Medical record use research
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 14 Sep 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: about 2000 population with TNBC
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
- Conditions
- TNBC - Triple-Negative Breast Cancer
- Being tested
- Medical record use research
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical record use researchOther
Medical record use research
What is being measured
The primary outcome is the main question the study is designed to answer.
primary purpose
Evaluate pathologic complete response, pCR,ypT0N0
Measured: 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)
Measured: until 2027.12.31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start14 Sep 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TNBC - Triple-Negative Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeon Hee Park
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yeon Hee Park, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828652
- Sponsor's protocol ID
- 2026-08-063
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07828652
- Acronym / sponsor ID
- 2026-08-063
- Conditions
- TNBC - Triple-Negative Breast Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Yeon Hee ParkUniversity, hospital or other
- Study start
- 14 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- about 2000 population with TNBC
Key inclusion criteria (3 listed)
- Age of 19 years or older at the start of treatment
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical record use researchMedical record use research | Other | – |
Primary outcome
primary purpose
Time frame: until 2027.12.31
Evaluate pathologic complete response, pCR,ypT0N0
1 secondary outcome
Outcome Measure
Time frame: until 2027.12.31
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: Undecided
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A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC)
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RecruitingPhase 3
Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of TNBC - Triple-Negative Breast Cancer, run by Yeon Hee Park.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yeon hee Park, MD,phD (82-10-9933-1780, yoenh.park@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary purpose (time frame: until 2027.12.31). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.