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

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Invasive Ductal Carcinoma, Breast

Interventions

CryoablationPROCEDURE

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 1 day after cryoablation

Immune response

Immunohistochemical analysis of biomarkers in blood and resected tissue

Time frame: One week after lumpectomy

Cosmetic outcome

Change in appearance based on distortion and volume loss of the breast

Time frame: 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

Time frame: 7-10 days after lumpectomy

Data from ClinicalTrials.gov

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