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

Johns Hopkins Medicine

Status: Withdrawn

Conditions: Invasive Ductal Carcinoma, Breast

Treatments: Procedure: Cryoablation

Study type: Interventional

Funder types: Other

Identifiers

NCT03523299

SIB16134

IRB00077843 (Other Identifier)

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Cryoablation

Experimental group

Description:

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).

Treatment:

Procedure: Cryoablation

Control

No Intervention group

Description:

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).