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

NCT03523299 | Withdrawn

• 2 other identifiers: SIB16134IRB00077843
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Invasive Ductal Carcinoma, Breast

Keywords

invasive ductal carcinoma; breast cancer; cryoablation

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Cryoablation

EXPERIMENTAL

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

Control

NO INTERVENTION

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).

Interventions

Cryoablation PROCEDURE

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.

Also known as: cryosurgery, cryotherapy

Cryoablation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

MeSH Terms

Conditions

Carcinoma, Ductal, Breast; Breast Neoplasms

Interventions

Cryosurgery; Cryotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Therapeutics

Study Officials

• Cesar Santa-Maria, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: May 14, 2018
• Study Start: May 22, 2018
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: August 21, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share