NCT07011823Not yet recruitingPhase 2
Immune-checkpoint Blockade After Partial Breast Irradiation by Pembrolizumab in Early TNBC
Phase II Trial of Immunochemotherapy and Partial Breast Irradiation in Early TNBC With Immune-cold Tumor Environment (KEY-MELT)
Source: ClinicalTrials.gov · Last updated 10 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 2 Jun 2025
- Start date
- 16 Jul 2025
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Gangnam Severance Hospital
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT07011823
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- From 16 Jul 2025 to the primary completion date, 31 Jul 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients scheduled for surgery without neoadjuvant chemotherapy
- 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
Other illness
- Patients with non-triple-negative breast cancer on tissue biopsy
- Patients with recurrent breast cancer or de novo stage IV disease
Other
- Patients with TILs ≥30% or PD-L1 CPS ≥10 on immunohistochemical staining of biopsy specimens (immune-hot tumor)
- Vulnerable research subjects who are unable to participate voluntarily in the study due to physical/mental disabilities
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.