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Can Real-World data match trial results for pembrolizumab in Triple-Negative breast cancer?

NCT ID NCT07828652

Knowledge-focused Sponsor: Yeon Hee Park Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers in Korea are reviewing medical records from about 2,000 patients with triple-negative breast cancer who received pembrolizumab plus chemotherapy before surgery. The study measures how many patients had no detectable cancer left in their breast and lymph nodes at surgery, and tracks recurrence and survival. Because it uses existing records rather than assigning treatments, it reflects how the therapy performs in routine practice rather than in a controlled trial.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pembrolizumab, given with chemotherapy before surgery
What this could lead to
If the real-world results match those seen in earlier trials, this could support broader confidence in using pembrolizumab before surgery for triple-negative breast cancer.
What could go wrong
This study looks back at medical records rather than assigning treatments, so it cannot prove cause and effect. Results may differ from controlled trials because of differences in patients, dosing, and care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 2,000 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

about 2000 population with TNBC

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 surgery

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Conditions

The condition(s) this trial relates to.

triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

TNBC - triple-negative breast cancer

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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