Invasive Ductal Carcinoma, Breast
Conditions
Keywords
invasive ductal carcinoma, breast cancer, cryoablation
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.
Interventions
PROCEDURECryoablation
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.
Sponsors
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed