Pilot Study to Define the Immune Response Following Cryoablation of Invasive Breast Cancer

Study Overview
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Brief Summary
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This study will investigate the safety, feasibility, and immune response associated with cryoablation of early invasive breast cancer prior to lumpectomy. Based on mouse models, the investigators believe that cryoablation will initiate a stronger immune response relative to the control group. Consenting patients will be randomized to one of two arms: standard of care (control) or cryoablation (intervention). Participants will undergo a blood draw at the time of consent. Those in the control arm will continue with their standard of care lumpectomy. The intervention arm will receive cryoablation 2 weeks before their scheduled lumpectomy and undergo a second blood draw before the lumpectomy.

Official Title
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Pilot Study to Define the Immune Response Following Cryoablation of Invasive Breast Cancer

Conditions
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Invasive Ductal Carcinoma, Breast

Intervention / Treatment
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* Procedure: Cryoablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ultrasound visible invasive ductal carcinoma (IDC) diagnosed by core needle biopsy; Tumor visible by ultrasound at time of treatment; Unifocal primary disease; Tumor size between 0.5 cm and 2.0 cm (as measured on ultrasound); Tumor depth ≥ 0.5 cm from the skin or nipple-areola complex; Planned lumpectomy Exclusion Criteria: Pregnant patients Multifocal or metastatic disease Planned neoadjuvant chemotherapy or radiation Extensive ductal carcinoma in situ (DCIS; >25% DCIS component) either diagnosed on core biopsy or strongly suggested by imaging Known allergy to both lidocaine and benzocaine

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryoablation<br>Participants in this arm will receive cryoablation of their breast tumor two weeks before their routine lumpectomy. They will undergo two blood draws: one before cryoablation (at the time of consent) and one after cryoablation (at the time of surgery). | Procedure: Cryoablation<br>* Cryoablation is a non-surgical, minimally invasive freezing procedure used to destroy tumors. In the breast, cryoablation is performed under ultrasound guidance. Due to the analgesic properties of freezing, no IV sedation or anesthesia is required. After administration of local anesthetic, the physician makes a 2-3 mm incision and inserts needle-like cryoprobes into the tumor, commencing a number of freeze-thaw cycles. Then the probe is removed, pressure is applied to the area, and a bandage is placed. The patient leaves the office without stitches and minimal, if any, pain. Any residual pain after the procedure is routinely treated with over the counter analgesics such as acetaminophen.<br>* Other names: cryotherapy;|
| No Intervention: Control<br>Participants in this arm will undergo a blood draw at the time of consent and then will continue with their scheduled lumpectomy (standard of care). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events [safety] | Assessed via phone call with participant and including any participant-reported adverse events, such as pain, bruising, bleeding, swelling, and skin changes | 1 day after cryoablation | 
| Immune response | Immunohistochemical analysis of biomarkers in blood and resected tissue | One week after lumpectomy | 
| Cosmetic outcome | Change in appearance based on distortion and volume loss of the breast | Change from one month to one year after lumpectomy | 
| Tumor margin status [effectiveness] | Assessment of whether excised tumor's margins are positive or negative for cancer, and whether re-excision is required | 7-10 days after lumpectomy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, cryoablation, invasive ductal carcinoma