Post-Marketing Study for Early-Stage Low-Risk Breast Cancer Treatment Using ProSense® Cryoablation (ChoICE Trial)

Post Marketing Data Collection on Use of ProSense® Cryoablation System With Adjuvant Endocrine Therapy for the Treatment of Patients With Low-Risk, Early-Stage Breast Cancer (ChoICE Trial)

The FDA has granted marketing authorization for the ProSense® Cryoablation System for the local treatment of patients aged 70 years or older with low-risk early-stage breast cancer who are also receiving adjuvant hormone therapy.

This clinical trial is designed to collect additional data on the safety and effectiveness of cryoablation when used as part of routine clinical care. Specifically, the study will evaluate recurrence rates following the procedure for up to 5 years post-treatment.

In addition, linkage to claims data will be used to assess long-term outcomes, including breast cancer-related surgeries, mammograms and other breast imaging procedures, breast biopsies, and all-cause mortality.

Inclusion Criteria:

1. Provision of a signed and dated informed consent form.

2. Age ≥70

3. Diagnosis of invasive ductal breast carcinoma (IDC) by core needle biopsy, meeting the following criteria:

   • Unifocal primary disease
   • Tumor size ≤1.5 cm in greatest diameter
   • Estrogen receptor positive, Progesterone receptor positive, and HER2 negative
   • Low-risk tumor biology, defined as Ki67<15% or confirmed by genomic testing. In cases where Ki67 is ≥15%, low-risk status must be confirmed by genomic testing, which will prevail.

4. Lesions must be sonographically visible at the time of treatment

5. Clinically negative lymph node (N0).

Exclusion Criteria:

1. Presence of lobular carcinoma.
2. Presence of microinvasion or invasive breast carcinoma with extensive intraductal component (EIC), defined as DCIS component comprising ≥25%.
3. Evidence of lymphovascular invasion.
4. Presence of multifocal and/or multicentric breast cancer.
5. Presence of multifocal suspicious calcifications.
6. Presence of inflammatory features.
7. Previous ipsilateral breast radiation
8. Neoadjuvant endocrine treatment is provided to reduce the tumor size.
9. Prior or concurrent neoadjuvant chemotherapy, biological therapy, or other targeted neo-therapies.
10. Prior en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer.
11. Allergy to local anesthesia.
12. Any other reason defined as inoperable declared by a physician.