Breast NeoplasmsPhase 2NCT03492918
Pembrolizumab and Paclitaxel in Hypermutated Breast Cancer
A Phase 2 study testing Pembrolizumab, paclitaxel in people with Breast Neoplasms, run by Yonsei University at 1 site in South Korea.
Trial summary
Abbreviated Title: Pembrolizumab in hypermutated breast cancer Trial Phase: II Clinical Indication: Hormone receptor-positive metastatic breast cancer Trial Type: Interventional Type of control: None Route of administration: Intravenous Trial Blinding: None Treatment Groups: Pembrolizumab plus Paclitaxel Number of… Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Pembrolizumab, paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Mar 2022to 19 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with histologically or cytologically confirmed premenopausal or postmenopausal, hormone receptor-positive, stage IV breast cancer.
- Definition of hormone receptor positivity: nuclear staining of tumor cells for ER or PR between 1% and 100% on immunochemical staining using a tumor sample (ASCO/CAP guideline 2020).
- Patients who have given written informed consent for this clinical study.
- Patients who have not received systemic cytotoxic chemotherapy in the metastatic setting. Hormone therapy and anti-HER2 targeted therapy are not limited; however, patients are excluded if an anti-HER2 agent and a cytotoxic chemotherapeutic agent were used together as first-line therapy. (Patients who have received a PARP inhibitor are eligible for enrollment.)
- Patients over 19 years of age as of the date of written informed consent.
- Patients who meet the criteria for hypermutation based on whole-exome sequencing.
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- Criteria for hypermutation: the number of nonsynonymous mutations is initially set at 70 or more, and is adjusted to the value corresponding to the top 20% or higher through interim analysis performed for every 30 cases. That is, the standard may change approximately every 30 cases.
- Patients with a metastatic tumor that can be biopsied for whole-exome sequencing. Biopsy of a breast or axillary lymph node tumor is also allowed for patients with local recurrence after surgery or with stage IV disease from diagnosis.
- Patients with one or more measurable lesions based on RECIST v1.1. Biopsied tissue is considered a measurable lesion if not resected.
- Patients whose disease progression has been confirmed since the most recent treatment (not applicable at the prescreening stage; i.e., tissue biopsy is possible while maintaining the existing treatment).
- Patients with an expected life span of 12 weeks or more.
- ECOG performance status of 0 to 1.
- Patients whose organ function eligibility test, conducted within 14 days prior to the start of treatment, meets the criteria summarized in Table 2 below.
- Table 2. Adequate Organ Function Laboratory Values
- In the case of women of childbearing potential, a negative pregnancy reaction confirmed by a urine or serum pregnancy test within 72 hours prior to the first administration of the study drug. If the urine test is positive or negative but difficult to confirm, a serum pregnancy test is required.
- For women of childbearing potential, willingness to use an appropriate method of contraception as described in Appendix 3 by day 180 after the last dose of the investigational drug.
- Note: If abstinence is the subject's routine lifestyle and preferred method of contraception, that method is also permitted.
Who cannot join
- Women of childbearing potential who have a positive urine pregnancy test within 72 hours prior to the first administration of the study drug (see criterion 7). If the urine test cannot be confirmed as negative, a serum pregnancy test must be performed. In this case, if the serum pregnancy test is positive, the subject must be excluded from the study.
- Has a history of prior treatment with agents targeting anti-PD-1, anti-PD-L1, or anti-PD-L2, or other stimulatory or co-inhibitory T-cell receptors (e.g., CTLA-4, OX40, CD137).
- Has received prior systemic therapy, including the study drug, within 4 weeks before the first dose [for kinase inhibitors or other short half-life drugs, if a period of at least 5 half-lives has not elapsed before randomization]. However, enrollment is permitted even within 4 weeks if 5 half-lives have elapsed and the adverse effects of the prior systemic therapy have completely resolved.
- Has received prior radiation therapy within 2 weeks before the start of treatment. Subjects must have recovered from all radiation-related toxicity, must not require corticosteroids, and must not have developed radiation pneumonitis. A 1-week washout period is permitted for palliative radiation (≤2 weeks of radiation therapy) for non-CNS disease.
- Has received a live vaccine within 30 days before the first dose of the investigational drug.
- -Note: Seasonal influenza vaccines are generally inactivated influenza virus vaccines and are therefore permitted for study participation. However, intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines and are not permitted for study participation.
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- Is currently participating in a clinical trial, or has participated in a clinical trial of an investigational drug and received investigational treatment or used an investigational medical device within 4 weeks before the first dose of the investigational drug.
- -Note: Subjects currently participating in an observational study may be enrolled in this trial if 4 weeks have elapsed since the last study drug administration.
- Has been diagnosed with immunodeficiency, or is chronically receiving systemic steroid therapy (at a dose exceeding the equivalent of 10 mg prednisone daily) or any other form of immunosuppressive therapy within 7 days before the first dose of the study drug.
- Has a known additional invasive malignancy that is progressing or has required active treatment within the past 2 years.
- Note: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the cervix who have been treated with curative intent are not subject to this exclusion.
- Has active central nervous system (CNS) metastases and/or carcinomatous meningitis; such subjects are excluded from the trial. Subjects previously treated for brain metastases may participate if they are stable (no evidence of disease progression on imaging for at least 4 weeks before the first dose of the study drug and neurological symptoms have returned to baseline), have no new or enlarging brain metastases, and will not require steroids for at least 7 days before study treatment. Carcinomatous meningitis is excluded regardless of clinical stability.
- Has a history of hypersensitivity to pembrolizumab or its excipients.
- Has hypersensitivity (grade 2 or higher peripheral neuropathy) or a contraindication to paclitaxel or its excipients.
- Has an active autoimmune disease that has required systemic treatment within the past 2 years (e.g., use of disease-modifying agents, corticosteroids, or immunosuppressive drugs); such subjects are excluded. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
- Has clinically significant cardiovascular disease (including unstable angina, myocardial infarction, stroke, and transient ischemic attack) or uncontrolled hypertension (SBP > 140 mmHg or DBP > 90 mmHg despite medication), as judged by the investigator, that occurred within 24 weeks before study participation.
- Has active non-infectious pneumonitis or a history of non-infectious pneumonitis; such subjects are excluded.
- Has an active infection requiring systemic treatment; such subjects are excluded.
- Has a history of immunodeficiency virus (HIV 1/2 or HTLV-1 antibody).
- Has active hepatitis B (HBs antigen +) or hepatitis C (anti-HCV antibody +) on laboratory testing within 180 days before the first dose of the study drug.
- However, enrollment is permitted if the following are demonstrated within 60 days before the first dose of the study drug:
- For HBs antigen +: enrollment is permitted if the subject is inactive without treatment (HBV DNA < 20 IU/mL), or if the viral load is undetectable while on antiviral therapy (HBV DNA < 20 IU/mL).
- For anti-HCV antibody +: enrollment is permitted if an HCV RNA PCR test is performed and is negative. However, subjects who are anti-HCV antibody + and have not undergone HCV RNA PCR testing are not eligible for enrollment.
- Has current active tuberculosis.
- Has any condition, treatment, or laboratory abnormality that could confound the study results or interfere with the subject's participation for the entire duration of the study, or is, in the investigator's opinion, otherwise unsuitable for participation in the study.
- Has a psychiatric disorder or substance abuse disorder that would interfere with the requirements of the clinical study.
- Is a woman who is currently pregnant or breastfeeding, or a woman of childbearing potential who is unwilling to continuously use an effective method of contraception from the time of the prescreening or screening visit through 180 days after the last dose of the study drug.
- Has received an allogeneic tissue/solid organ transplant.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei Cancer Center at Yonsei University Health System
Seoul, 03722
About this study
Official title: Phase II Trial of Pembrolizumab in Combination With Paclitaxel in the Hormone Receptor-positive Metastatic Breast Cancer With High Tumor Mutational Burden Selected by Whole Exome Sequencing: Korean Cancer Study Group Trial (KCSG BR20-16)
Abbreviated Title: Pembrolizumab in hypermutated breast cancer Trial Phase: II Clinical Indication: Hormone receptor-positive metastatic breast cancer Trial Type: Interventional Type of control: None Route of administration: Intravenous Trial Blinding: None Treatment Groups: Pembrolizumab plus Paclitaxel Number of trial subjects: Approximately 200 patients will be prescreened with whole exome sequencing. Then 52 patients will be enrolled in the treatment phase.
Estimated enrollment period: 12 months Estimated duration of trial: The sponsor estimates that the trial will require approximately 48 months from the time the first subject signs the informed consent until the last subject's last visit.
Duration of Participation: 12 months Estimated average length of treatment per patient: 8 months
- Conditions
- Breast Neoplasms
- Being tested
- Pembrolizumab, paclitaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pembrolizumab, paclitaxelDrug
Also called Keytruda
Enrolled patients received pembrolizumab (200 mg every 3 weeks) plus paclitaxel (80 mg/m² on days 1, 8, and 15 of a 28-day cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Pembrolizumab was administered up to 35 cycles if patient showed persistent clinical response. According to pre-specified dose modification guidelines, dose reduction of weekly paclitaxel was permitted for management of toxicities. Dose modification of pembrolizumab was not permitted.
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab + Paclitaxel | Experimental | Patients with hormone receptor-positive metastatic breast cancer identified as hypermutated (nonsynonymous mutations ≥ 70 per tumor) by whole exome sequencing receive pembrolizumab 200 mg as an intravenous infusion every 3 weeks (up to 35 cycles), in combination with paclitaxel 80 mg/m² administered as an intravenous infusion on Days 1, 8, and 15 of each 28-day cycle. Receives: Drug: Pembrolizumab, paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator-assessed objective response rate (ORR)
ORR was defined as the proportion of patients showing a complete response (CR) or partial response (PR) over the total patient population.
Measured: Tumour assessment was performed at baseline and every 8 weeks (+/- 7 days) based on appropriate imaging studies, such as computed tomography (CT) scans or magnetic resonance imaging (MRI) scans until progressive disease based on RECIST criteria version 1
Secondary outcomes (5)
progression-free survival (PFS)
PFS was calculated from the first date of paclitaxel and pembrolizumab administration to the date of disease progression confirmed by imaging studies or patients' death.
Measured: through study completion
overall survival (OS)
OS was defined from the start date of paclitaxel plus pembrolizumab administration to patients' death or to last follow-up date
Measured: through study completion
duration of response (DoR)
DoR was defined as the time from the first documentation of objective response (CR or PR) to radiographic disease progression or death from any cause
Measured: through study completion
clinical benefit rate (CBR)
CBR was defined as the proportion of patients with CR, PR or stable disease lasting ≥24 weeks
Measured: 24 weeks
safety
Safety was assessed based on National Cancer Institute - Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0)
Measured: through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start31 Mar 2022
- Primary completion19 Jun 2026
- Study completion19 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492918
- Sponsor's protocol ID
- 4-2018-0264
- Status last verified
- Oct 2026
- First submitted
- 1 Apr 2018
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Pembrolizumab in Combination With Paclitaxel in the Hormone Receptor-positive Metastatic Breast Cancer With High Tumor Mutational Burden Selected by Whole Exome Sequencing: Korean Cancer Study Group Trial (KCSG BR20-16)
- ClinicalTrials.gov ID
- NCT03492918
- Acronym / sponsor ID
- 4-2018-0264
- Conditions
- Breast Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 19 Jun 2026 (actual)
- Study completion
- 19 Jun 2026 (actual)
- First posted
- 10 Apr 2018 (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.
Abbreviated Title: Pembrolizumab in hypermutated breast cancer Trial Phase: II Clinical Indication: Hormone receptor-positive metastatic breast cancer Trial Type: Interventional Type of control: None Route of administration: Intravenous Trial Blinding: None Treatment Groups: Pembrolizumab plus Paclitaxel Number of trial subjects: Approximately 200 patients will be prescreened with whole exome sequencing. Then 52 patients will be enrolled in the treatment phase.
Estimated enrollment period: 12 months Estimated duration of trial: The sponsor estimates that the trial will require approximately 48 months from the time the first subject signs the informed consent until the last subject's last visit.
Duration of Participation: 12 months Estimated average length of treatment per patient: 8 months
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab + Paclitaxel | Experimental | Drug: Pembrolizumab, paclitaxelPatients with hormone receptor-positive metastatic breast cancer identified as hypermutated (nonsynonymous mutations ≥ 70 per tumor) by whole exome sequencing receive pembrolizumab 200 mg as an intravenous infusion every 3 weeks (up to 35 cycles), in combination with paclitaxel 80 mg/m² administered as an intravenous infusion on Days 1, 8, and 15 of each 28-day cycle. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Female patients with histologically or cytologically confirmed premenopausal or postmenopausal, hormone receptor-positive, stage IV breast cancer.
- Definition of hormone receptor positivity: nuclear staining of tumor cells for ER or PR between 1% and 100% on immunochemical staining using a tumor sample (ASCO/CAP guideline 2020).
- Patients who have given written informed consent for this clinical study.
- Patients who have not received systemic cytotoxic chemotherapy in the metastatic setting. Hormone therapy and anti-HER2 targeted therapy are not limited; however, patients are excluded if an anti-HER2 agent and a cytotoxic chemotherapeutic agent were used together as first-line therapy. (Patients who have received a PARP inhibitor are eligible for enrollment.)
- Patients over 19 years of age as of the date of written informed consent.
Key exclusion criteria (28 listed)
- Women of childbearing potential who have a positive urine pregnancy test within 72 hours prior to the first administration of the study drug (see criterion 7). If the urine test cannot be confirmed as negative, a serum pregnancy test must be performed. In this case, if the serum pregnancy test is positive, the subject must be excluded from the study.
- Has a history of prior treatment with agents targeting anti-PD-1, anti-PD-L1, or anti-PD-L2, or other stimulatory or co-inhibitory T-cell receptors (e.g., CTLA-4, OX40, CD137).
- Has received prior systemic therapy, including the study drug, within 4 weeks before the first dose [for kinase inhibitors or other short half-life drugs, if a period of at least 5 half-lives has not elapsed before randomization]. However, enrollment is permitted even within 4 weeks if 5 half-lives have elapsed and the adverse effects of the prior systemic therapy have completely resolved.
- Has received prior radiation therapy within 2 weeks before the start of treatment. Subjects must have recovered from all radiation-related toxicity, must not require corticosteroids, and must not have developed radiation pneumonitis. A 1-week washout period is permitted for palliative radiation (≤2 weeks of radiation therapy) for non-CNS disease.
- Has received a live vaccine within 30 days before the first dose of the investigational drug.
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 |
|---|---|---|
| Pembrolizumab, paclitaxelAlso: KeytrudaEnrolled patients received pembrolizumab (200 mg every 3 weeks) plus paclitaxel (80 mg/m² on days 1, 8, and 15 of a 28-day cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Pembrolizumab was administered up to 35 cycles if patient showed persistent clinical response. According to pre-specified dose modification guidelines, dose reduction of weekly paclitaxel was permitted for management of toxicities. Dose modification of pembrolizumab was not permitted. | Drug | Pembrolizumab + Paclitaxel |
Primary outcome
Investigator-assessed objective response rate (ORR)
Time frame: Tumour assessment was performed at baseline and every 8 weeks (+/- 7 days) based on appropriate imaging studies, such as computed tomography (CT) scans or magnetic resonance imaging (MRI) scans until progressive disease based on RECIST criteria version 1
ORR was defined as the proportion of patients showing a complete response (CR) or partial response (PR) over the total patient population.
5 secondary outcomes
progression-free survival (PFS)
Time frame: through study completion
overall survival (OS)
Time frame: through study completion
duration of response (DoR)
Time frame: through study completion
clinical benefit rate (CBR)
Time frame: 24 weeks
safety
Time frame: through study completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab, paclitaxel in people with Breast Neoplasms, run by Yonsei University at 1 site in South Korea.
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 17 inclusion and 28 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: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator-assessed objective response rate (ORR) (time frame: Tumour assessment was performed at baseline and every 8 weeks (+/- 7 days) based on appropriate imaging studies, such as computed tomography (CT) scans or magnetic resonance imaging (MRI) scans until progressive disease based on RECIST criteria version 1). 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 13 Oct 2026.