Triple-Negative Breast NeoplasmPhase 2KEY-MELTNCT07011823
Immune-checkpoint Blockade After Partial Breast Irradiation by Pembrolizumab in Early TNBC
A Phase 2 study testing Partial breast-irradiation in people with Triple-Negative Breast Neoplasm, run by Gangnam Severance Hospital.
Trial summary
A single-arm, single-institution study to induce phenotypic changes in the tumor microenvironment by delivering 8Gy partial breast irradiation in immune-cold triple-negative breast cancer confirmed by PD-L1 and TILs. Additional tissue biopsy will be performed following radiation therapy. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Triple-Negative Breast Neoplasm
- What is being tested?
- Partial breast-irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 16 Jul 2025to 31 Jul 2033
- Phase
- Phase 2
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer patients aged 20 years or older with clinical stage IIA or higher on imaging studies
- Patients with triple-negative breast cancer confirmed on tissue biopsy
- Cold immune tumor environment with tumor-infiltrating lymphocytes (TILs) <30% and PD-L1 Combined Positive Score (CPS) <10 on immunohistochemical staining of biopsy specimens
- Patients with no prior history of breast cancer
- Patients with no prior history of chemotherapy or radiation therapy
- Patients scheduled to receive partial breast irradiation
- Patients with ECOG performance status of 0-2
- Patients who voluntarily signed the informed consent form for study participation
Who cannot join
- Patients with non-triple-negative breast cancer on tissue biopsy
- Patients scheduled for surgery without neoadjuvant chemotherapy
- Patients with TILs ≥30% or PD-L1 CPS ≥10 on immunohistochemical staining of biopsy specimens (immune-hot tumor)
- Patients with recurrent breast cancer or de novo stage IV disease
- Patients who have previously received chemotherapy and/or radiation therapy to the ipsilateral breast and chest prior to study participation
- Patients unable to receive neoadjuvant chemotherapy and Pembrolizumab
- Vulnerable research subjects who are unable to participate voluntarily in the study due to physical/mental disabilities
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Soong June Bae, M.D.,Ph.D. contact
About this study
Official title: Phase II Trial of Immunochemotherapy and Partial Breast Irradiation in Early TNBC With Immune-cold Tumor Environment (KEY-MELT)
A single-arm, single-institution study to induce phenotypic changes in the tumor microenvironment by delivering 8Gy partial breast irradiation in immune-cold triple-negative breast cancer confirmed by PD-L1 and TILs. Additional tissue biopsy will be performed following radiation therapy. Subsequently, neoadjuvant chemotherapy including Pembrolizumab will be administered to evaluate whether pathological complete response rates are improved.
Read the detailed description
A single-arm, single-institution study to induce phenotypic changes in the tumor microenvironment by delivering 8Gy partial breast irradiation in immune-cold triple-negative breast cancer confirmed by PD-L1 and TILs. Additional tissue biopsy will be performed following radiation therapy.
Subsequently, under the supervision and management of breast surgery and medical oncology research teams, standard neoadjuvant chemotherapy for triple-negative breast cancer including pembrolizumab, paclitaxel, carboplatin, doxorubicin, and cyclophosphamide (KeyNote-522 regimen) will be administered, followed by surgical treatment.
Pathological complete response status in surgical specimens will be confirmed and reported by the pathologist.
Pathological examination and spatial multiplex analysis will be performed on biopsy and surgical specimens to explore biomarkers with significant changes.
As secondary end-points, disease-free survival and overall survival will be assessed.
- Conditions
- Triple-Negative Breast Neoplasm
- Being tested
- Partial breast-irradiation
- Keywords
- Immune-cold microenvironment, Triple-negative breast cancer, Partial Breast Irradiation, Pembrolizumab, KeyNote-522, Immunochemotherapy
- 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.
Partial breast-irradiationRadiation
First, 8Gy partial breast irradiation will be delivered in immune-cold triple-negative breast cancer (TNBC) confirmed by PD-L1 and TILs.
Sequentially, standard neoadjuvant chemotherapy for triple-negative breast cancer including pembrolizumab, paclitaxel, carboplatin, doxorubicin, and cyclophosphamide (KeyNote-522 regimen) will be administered, followed by surgical treatment.
| Study group | Role | What they receive |
|---|---|---|
| Immunochemotherapy including pembrolizumab after partial breast-irradiation | Experimental | First, 8Gy partial breast irradiation will be delivered in immune-cold triple-negative breast cancer (TNBC) confirmed by PD-L1 and TILs.
Sequentially, standard neoadjuvant chemotherapy for triple-negative breast cancer including pembrolizumab, paclitaxel, carboplatin, doxorubicin, and cyclophosphamide (KeyNote-522 regimen) will be administered, followed by surgical treatment. Receives: Radiation: Partial breast-irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response
Measured: Within 3 weeks after surgical treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start16 Jul 2025 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Triple-Negative Breast NeoplasmStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung Gwe Ahn, Gangnam Severance Hospital
- Investigators
- Sung Gwe Ahn, Principal investigator, M.D.,Ph.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011823
- Sponsor's protocol ID
- 3-2025-0070
- Acronym
- KEY-MELT
- Status last verified
- Jun 2025
- First submitted
- 2 Jun 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Schmid P, Cortes J, Dent R, McArthur H, Pusztai L, Kummel S, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Im SA, Untch M, Fasching PA, Mouret-Reynier MA, Foukakis T, Ferreira M, Cardoso F, Zhou X, Karantza V, Tryfonidis K, Aktan G, O'Shaughnessy J; KEYNOTE-522 Investigators. Overall Survival with Pembrolizumab in Early-Stage Triple-Negative Breast Cancer. N Engl J Med. 2024 Nov 28;391(21):1981-1991. doi: 10.1056/NEJMoa2409932. Epub 2024 Sep 15.
PubMed 39282906
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Immunochemotherapy and Partial Breast Irradiation in Early TNBC With Immune-cold Tumor Environment (KEY-MELT)
- ClinicalTrials.gov ID
- NCT07011823
- Acronym / sponsor ID
- KEY-MELT / 3-2025-0070
- Conditions
- Triple-Negative Breast Neoplasm
- Keywords
- Immune-cold microenvironment, Triple-negative breast cancer, Partial Breast Irradiation, Pembrolizumab, KeyNote-522, Immunochemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 16 Jul 2025 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2033 (estimated)
- First posted
- 10 Jun 2025 (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.
A single-arm, single-institution study to induce phenotypic changes in the tumor microenvironment by delivering 8Gy partial breast irradiation in immune-cold triple-negative breast cancer confirmed by PD-L1 and TILs. Additional tissue biopsy will be performed following radiation therapy. Subsequently, neoadjuvant chemotherapy including Pembrolizumab will be administered to evaluate whether pathological complete response rates are improved.
Detailed description
A single-arm, single-institution study to induce phenotypic changes in the tumor microenvironment by delivering 8Gy partial breast irradiation in immune-cold triple-negative breast cancer confirmed by PD-L1 and TILs. Additional tissue biopsy will be performed following radiation therapy.
Subsequently, under the supervision and management of breast surgery and medical oncology research teams, standard neoadjuvant chemotherapy for triple-negative breast cancer including pembrolizumab, paclitaxel, carboplatin, doxorubicin, and cyclophosphamide (KeyNote-522 regimen) will be administered, followed by surgical treatment.
Pathological complete response status in surgical specimens will be confirmed and reported by the pathologist.
Pathological examination and spatial multiplex analysis will be performed on biopsy and surgical specimens to explore biomarkers with significant changes.
As secondary end-points, disease-free survival and overall survival will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immunochemotherapy including pembrolizumab after partial breast-irradiation | Experimental | Radiation: Partial breast-irradiationFirst, 8Gy partial breast irradiation will be delivered in immune-cold triple-negative breast cancer (TNBC) confirmed by PD-L1 and TILs. Sequentially, standard neoadjuvant chemotherapy for triple-negative breast cancer including pembrolizumab, paclitaxel, carboplatin, doxorubicin, and cyclophosphamide (KeyNote-522 regimen) will be administered, followed by surgical treatment. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Breast cancer patients aged 20 years or older with clinical stage IIA or higher on imaging studies
- Patients with triple-negative breast cancer confirmed on tissue biopsy
- Cold immune tumor environment with tumor-infiltrating lymphocytes (TILs) <30% and PD-L1 Combined Positive Score (CPS) <10 on immunohistochemical staining of biopsy specimens
- Patients with no prior history of breast cancer
- Patients with no prior history of chemotherapy or radiation therapy
Key exclusion criteria (7 listed)
- Patients with non-triple-negative breast cancer on tissue biopsy
- Patients scheduled for surgery without neoadjuvant chemotherapy
- Patients with TILs ≥30% or PD-L1 CPS ≥10 on immunohistochemical staining of biopsy specimens (immune-hot tumor)
- Patients with recurrent breast cancer or de novo stage IV disease
- Patients who have previously received chemotherapy and/or radiation therapy to the ipsilateral breast and chest prior to study participation
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 |
|---|---|---|
| Partial breast-irradiationFirst, 8Gy partial breast irradiation will be delivered in immune-cold triple-negative breast cancer (TNBC) confirmed by PD-L1 and TILs. Sequentially, standard neoadjuvant chemotherapy for triple-negative breast cancer including pembrolizumab, paclitaxel, carboplatin, doxorubicin, and cyclophosphamide (KeyNote-522 regimen) will be administered, followed by surgical treatment. | Radiation | Immunochemotherapy including pembrolizumab after partial breast-irradiation |
Primary outcome
Pathologic complete response
Time frame: Within 3 weeks after surgical treatment
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 10 Jun 2025.
- Background: PubMed 39282906Schmid P, Cortes J, Dent R, McArthur H, Pusztai L, Kummel S, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Im SA, Untch M, Fasching PA, Mouret-Reynier MA, Foukakis T, Ferreira M, Cardoso F, Zhou X, Karantza V, Tryfonidis K, Aktan G, O'Shaughnessy J; KEYNOTE-522 Investigators. Overall Survival with Pembrolizumab in Early-Stage Triple-Negative Breast Cancer. N Engl J Med. 2024 Nov 28;391(21):1981-1991. doi: 10.1056/NEJMoa2409932. Epub 2024 Sep 15.
- Individual participant dataSharing planned: Undecided
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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.
Soong June Bae, M.D.,Ph.D. contact
Sung Gwe Ahn principal investigator
M.D.,Ph.D.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Partial breast-irradiation in people with Triple-Negative Breast Neoplasm, run by Gangnam Severance Hospital.
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 8 inclusion and 7 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 10 Jun 2025. 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.
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?
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 Sung Gwe Ahn, M.D.,Ph.D. (+82220193370, asg2004@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic complete response (time frame: Within 3 weeks after surgical treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07011823, which also lists 1 linked publication.
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 10 Jun 2025.