Clinical trial · Interventional
A Study of Pembrolizumab and Ablation (Cryoablation or Histotripsy) in People With Breast Cancer
Does Ablation (Cryoablation or Histotripsy) Boost Immune Response Improving the Benefits of Pembrolizumab in Patients With Metastatic or Locally Advanced Triple Negative Breast Cancer?
NCT06246968CI-TRIAL-00112105recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
Participants will have a confirmed diagnosis of metastatic breast cancer and will receive pembrolizumab in combination with ablation (cryoablation or histotripsy) OR pembrolizumab alone. Participants will be randomly assigned.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer Stage IV | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Locally Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Locally Advanced Triple-Negative Breast Carcinoma | Triple-Negative Breast Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Triple-Negative Breast Carcinoma | Triple-Negative Breast Carcinoma | CURATED_BROADER | 0.78 |
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
| Triple Negative Breast Neoplasms | Triple-Negative Breast Carcinoma | ALIAS |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryoablation | Device | — | UNRESOLVED |
| Histotripsy | Device | — | UNRESOLVED |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pembrolizumab + Ablation (Cryoablation or Histotripsy)
- description
- Participants will have a diagnosis of metastatic triple negative breast cancer or locally advanced inoperable triple negative breast cancer. Participants will be randomized 2 (ablation arm): 1 (no ablation arm).
- interventionNames
- Drug: Pembrolizumab
- Device: Cryoablation
- Device: Histotripsy
- type
- ACTIVE_COMPARATOR
- label
- Pembrolizumab
- description
- Participants will have a diagnosis of metastatic triple negative breast cancer or locally advanced inoperable triple negative breast cancer. Participants will be randomized 2 (ablation arm): 1 (no ablation arm).
- interventionNames
- Drug: Pembrolizumab
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Patients ≥ 18 years of age
* Confirmed histologic diagnosis of metastatic TNBC or locally advanced inoperable TNBC
* 1 site amenable cryoablation of at least 1.5 cm in size as determined by an Interventional Radiologist. Eligible cryoablation sites include (but not limited to) soft tissue, liver, lung, and bone as determined by an Interventional Radiologist to be safest and most feasible.
* Physically fit (clinically eligible) to undergo ablation as per usual clinical practice
* Per clinical guidelines, women of childbearing age should use effective contraception during treatment with pembrolizumab and for at least 4 months after the last dose of the drug, which will be assessed and monitored by, and the responsibility of, the patient's medical oncologist (not study investigators or research team) as pembrolizumab is standard of care. Memorial Sloan Kettering Cancer Center Pregnancy Standards will be followed prior to ablation. That is, female patients that are 11-50 years of age and of childbearing potential will undergo a pregnancy test within 2 weeks (15 days) before ablation. Pregnancy test will not be required in patients with bilateral oophorectomy, bilateral salpingectomy, bilateral salpingectomy-oophorectomy, hysterectomy, menopause (no menses ≥ 1 year prior to treatment or after completion of all treatment), or surgical sterilization (i.e. tubal ligation or blockage), with documentation of permanent exemptions in CIS ("Pregnancy Testing Exemption").
* Pembrolizumab therapy (200 mg every 3 weeks) planned as part of standard of care as first, second, or third line of therapy
* Eligible for PD-1 inhibitor per the patient's medical oncologist, with planned treatment with PD-1 inhibitor per the patient's medical oncologist. Additional systemic therapy is per the patient's medical oncologist. The following systemic therapy will be accepted (the timing of the systemic therapy relative to pembrolizumab and ablation is not restricted):
* Capecitabine (Xeloda, available as a generic drug)
* Carboplatin (Paraplatin, available as a generic drug)
* Cisplatin (Platinol, available as a generic drug)
* Cyclophosphamide (Cytoxan, available as a generic drug)
* Docetaxel (Taxotere)
* Doxorubicin (Adriamycin, available as a generic drug)
* Pegylated liposomal doxorubicin (Doxil)
* Epirubicin (Ellence, available as a generic drug)
* Eribulin (Halaven)
* Fluorouracil (5-FU, Adrucil, available as a generic drug)
* Gemcitabine (Gemzar, available as a generic drug)
* Ixabepilone (Ixempra)
* Methotrexate (available as a general drug)
* Nab-paclitaxel (Abraxane)
* Paclitaxel (Taxol, available as a generic drug)
* Vinorelbine (Navelbine, available as a generic drug)
Exclusion Criteria:
* Patient not eligible for PD-1 inhibitor per the patient's medical oncologist
* No disease amenable for ablation
* Pembrolizumab therapy not planned as part of standard of careReferences
Publications (0)
Data not yet available
No reference posted for this study.