Pilot Study to Define the Immune Response Following Cryoablation of Invasive Breast Cancer
- Conditions
- Invasive Ductal Carcinoma, Breast
- Interventions
- Procedure: Cryoablation
- Registration Number
- NCT03523299
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cryoablation 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).
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events [safety] 1 day after cryoablation Assessed via phone call with participant and including any participant-reported adverse events, such as pain, bruising, bleeding, swelling, and skin changes
Immune response One week after lumpectomy Immunohistochemical analysis of biomarkers in blood and resected tissue
Cosmetic outcome Change from one month to one year after lumpectomy Change in appearance based on distortion and volume loss of the breast
Tumor margin status [effectiveness] 7-10 days after lumpectomy Assessment of whether excised tumor's margins are positive or negative for cancer, and whether re-excision is required
- Secondary Outcome Measures
Name Time Method