Breast Cancer, Breast Cancer Stage IV, Locally Advanced Breast Cancer, Locally Advanced Triple-Negative Breast Carcinoma, Metastatic Breast Cancer, Metastatic Triple-Negative Breast Carcinoma, Triple Negative Breast Cancer, Triple Negative Breast Neoplasms
Conditions
Keywords
metastatic TNBC, metastatic triple negative breast carcinoma, metastatic breast cancer, breast cancer, breast cancer stage IV, triple negative breast cancer, pembrolizumab, cryoablation, Memorial Sloan Kettering Cancer Center, 23-390, locally advanced breast cancer, locally advanced triple negative breast carcinoma, locally advanced triple negative breast cancer
Brief summary
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.
Interventions
DRUGPembrolizumab
Participants will receive Pembrolizumab as part of standard of care treatment.
DEVICECryoablation
Cryoablation is a type of thermal ablation that is a minimally invasive alternative technique to surgical resection.
DEVICEHistotripsy
Histotripsy of the liver is a noninvasive, nonthermal ablation technique that employs high intensity focused ultrasound pulses to mechanically disrupt targeted hepatic tissues- typically liver tumors-via a process known as acoustic cavitation.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in CD4-PD1 from baseline to post-ablation | 6 weeks after cryoablation | Assess changes in CD4-PD1 in the blood after ablation in patients with metastatic or locally advanced triple negative breast cancer (TNBC). |
Countries
United States
Contacts
CONTACTYolanda Bryce, MD
CONTACTLarry Norton, MD
PRINCIPAL_INVESTIGATORYolanda Bryce, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed