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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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
70 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 years
  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study checks the safety and how well ProSense® cryoablation, a treatment that freezes cancer, works in routine care. It is for people age 70 or older with early-stage, low-risk breast cancer who also receive hormone therapy. It will track whether cancer comes back for up to 5 years and use health insurance records to study longer-term outcomes.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Sign and date a form agreeing to join the study.
  • Be age 70 or older.
  • Have invasive ductal breast cancer, which starts in a milk duct and spreads outside it, confirmed by a needle biopsy.
  • Have one cancer site, with a tumor no larger than 1.5 cm.
  • Have cancer that is estrogen receptor positive, progesterone receptor positive, and HER2 negative. These tests show which hormones and proteins may help the cancer grow.
  • Have low-risk cancer based on a Ki67 score below 15% or tumor gene testing. If Ki67 is 15% or higher, gene testing must confirm low risk.
  • The tumor must be visible on ultrasound at treatment.
  • Have no signs of cancer in nearby lymph nodes on a clinical exam.

Who can't join

  • Have lobular cancer, which starts in milk-making glands; cancer with only tiny areas of spread outside a duct; or invasive cancer with at least 25% DCIS, cancer still inside the ducts.
  • Have cancer in blood vessels or lymph vessels, or cancer in more than one spot in the breast.
  • Have suspicious calcium deposits in more than one spot, or signs of inflammation in the breast.
  • Have had radiation to the breast being treated.
  • Receive hormone treatment before the procedure to shrink the tumor, or have had or are receiving chemotherapy, biological therapy, or other targeted treatment before the procedure.
  • Have had an open surgical biopsy that removed tissue in one piece, or a lumpectomy, to diagnose or treat this cancer.
  • Have an allergy to local anesthesia, the medicine used to numb the treatment area.
  • A doctor says you cannot have surgery for another reason.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (2)

CA

TN