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

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 Overview

• Status: Withdrawn
• Conditions: Invasive Ductal Carcinoma, Breast
• Intervention / Treatment: Procedure: Cryoablation

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cryoablation; 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; 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.; Other Names: cryosurgery; cryotherapy
NO_INTERVENTION: Control; 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?

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

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Investigators: Principal Investigator: Cesar Santa-Maria, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 22, 2018
• Primary Completion (ACTUAL): August 1, 2019
• Study Completion (ACTUAL): August 1, 2019

Study Registration Dates

• First Submitted: April 5, 2018
• First Submitted That Met QC Criteria: May 1, 2018
• First Posted (ACTUAL): May 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 21, 2019
• Last Update Submitted That Met QC Criteria: August 19, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: breast cancer; cryoablation; invasive ductal carcinoma
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Breast Diseases; Neoplasms, Ductal, Lobular, and Medullary; Breast Neoplasms; Carcinoma, Ductal; Carcinoma, Ductal, Breast
• Other Study ID Numbers: SIB16134; IRB00077843 (OTHER: JHMIRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No