Standard care. Surgery, radiation and systemic therapy, chosen by stage and receptor status. Cryoablation on its own is authorized in the United States for one defined group: in October 2025 the FDA granted marketing authorization to IceCure's ProSense system for early-stage, low-risk breast cancer in women aged 70 or older with ER-positive, PR-positive, HER2-negative tumors of 1.5 cm or smaller, used with adjuvant endocrine therapy. That authorization covers cryoablation alone. In triple-negative disease, intravenous (IV) checkpoint blockade gives systemic drug exposure.
Ablation alone. Local treatment of the tumor; any immune effect of ablation alone is not established in patients.
This approach. Image-guided ablation of the breast tumor, by pulsed electric field (PEF) ablation in most cases and cryoablation in some, combined in the same session with a multi-agent intratumoral immunotherapy injected into the ablation bed. It is used across stages and receptor types, under physician review. In our clinical observations, a systemic immune response occurs beyond the treated tumor.
Rationale. Hormone-receptor-positive tumors are usually immune-quiet; triple-negative tumors often do not respond to checkpoint drugs given alone. WCI's rationale is that ablation exposes the tumor's antigens and that the injected agents drive an immune response to them at the site. This is what we see in our clinical observations.
The procedure, step by step
Guidance. Ultrasound-guided percutaneous access to the breast tumor.
Ablation. PEF delivers electrical pulses through the single needle, without heat; where cryoablation is used, cryoprobes form an ice ball around the tumor. Lethal cell kill occurs in the inner zone, where tissue falls below −40 °C. More than one freeze–thaw cycle is used to maximize cell death and antigen release. Dying cells release damage-associated molecular patterns (ATP, HMGB1, calreticulin) and intact protein antigens.
Intratumoral immunotherapy. A multi-agent combination is injected into the ablation bed, through the same needle after PEF or through a second needle after cryoablation. The combination is chosen from the tumor's biology (ER, PR, HER2 including HER2-low, Ki-67, BRCA, PD-L1, TROP-2) and from prior treatment.
Setting and time. About an hour for the procedure under conscious sedation, and about two hours of recovery. Most procedures are outpatient under conscious sedation; general anesthesia or an overnight stay is rarely required.
Follow-up. Imaging at 6 to 8 weeks (PET/CT, MRI or ultrasound as appropriate). Repeat procedures as indicated; the number of treatments is decided with the patient's physician. The patient's home oncology team is kept informed throughout.
Agents. The injected immunotherapy is a multi-agent combination. The agents and doses are set per patient by the treating physician.
The immune conversion cycle, in clinical terms. Ablation disrupts the tumor and exposes its full antigen repertoire, not a pre-selected subset. The injected immunotherapy then remodels the tumor microenvironment, priming, recruiting and activating immune cells and releasing the brakes on them. Immune-mediated lysis exposes further antigens, which re-prime the response (epitope spreading), producing a broader, polyclonal, systemic response with memory, converting a cold tumor hot. This is WCI’s stated rationale, in Dr. Goodyear’s framing, borne out in our clinical observations.
Evidence, and its limits. In mice with colorectal tumors and no ablation, anti-CTLA-4 injected into a tumor reached about 14 times the day-7 level of IV dosing in that tumor; the untreated tumor received no more than with IV dosing, and half the dose reached the blood within an hour [1]. That is mouse data in a colorectal model; it does not test ablation or show a distant-site effect. In a 2024 mouse model of triple-negative breast cancer, cryoablation of the primary tumor altered the immune microenvironment at distant sites [2]. Image-guided breast cryoablation as a technique dates to a 2004 multi-institutional pilot [3]. There is no randomized trial of cryoablation combined with intratumoral immunotherapy in breast cancer. The case under 'What the records show' is a case record, not a series with a denominator.
Sources[1] Meyblum L, et al. J Immunother Cancer 2023. PMID 37949616.[2] Sardela de Miranda F, et al. 2024. PMID 39703517 (mouse model of triple-negative breast cancer).[3] Sabel MS, et al. 2004. PMID 15123465 (multi-institutional pilot, image-guided breast cryoablation).