Cryoablation for Breast Cancer

Recruiting at 1 trial location

Overseen By Heather Garrett, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Surgical candidates, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called cryoablation for individuals with breast cancer who cannot or choose not to undergo surgery. Cryoablation uses extreme cold to destroy cancer cells, and researchers aim to determine its long-term safety and effectiveness. Participants will undergo imaging for up to three years to collect data on their health and the treatment's impact on their quality of life. This trial suits patients diagnosed with breast cancer whose tumors are visible on ultrasound and who are not candidates for surgery due to medical conditions or personal choice. As a Phase 2 trial, the study measures how well cryoablation works in an initial, smaller group, allowing participants to contribute to important research.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that cryoablation is safe for breast cancer patients?

Research has shown that cryoablation is a safe and effective treatment for breast cancer. This method has succeeded in treating patients with early-stage, advanced, and inoperable breast cancer. Cryoablation works by freezing and killing cancer cells, and patients have generally tolerated it well.

One study found that cryoablation for early-stage breast cancer resulted in excellent cancer control. Another study confirmed its safety, with patients experiencing only minor side effects. This treatment is also known for its good cosmetic results, meaning the breast looks more natural after the procedure.

Overall, cryoablation is a proven safe alternative to surgery for those who cannot undergo traditional operations. Studies consistently support its use, showing it to be a reliable option with few reported side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Cryoablation is unique because it offers a non-surgical approach to treating breast cancer by using extreme cold to target and kill cancer cells. Unlike traditional treatments like surgery, radiation, or chemotherapy, cryoablation is minimally invasive and can be performed with just an ultrasound-guided needle, reducing recovery time and potential complications. Researchers are excited because this method could improve quality of life for patients who are not candidates for surgery, offering a promising alternative with fewer side effects.

What evidence suggests that cryoablation is effective for breast cancer?

Research has shown that cryoablation, the treatment under study in this trial, effectively treats breast cancer. Studies have found it can completely destroy tumors in 90% of cases. When combined with hormonal therapy and radiation, the success rate can approach 100%. Another study found that cryoablation works as well as breast-conserving surgery, achieving a 98% success rate. This makes cryoablation a strong option for treating breast cancer in patients who cannot undergo surgery. ^{1 6 7 8 9}

Who Is on the Research Team?

Heather Garrett, M.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

Inclusion Criteria

You have been diagnosed with breast cancer.

The patient is medically unable to receive sedation or general anesthesia.

Surgery is not recommended because the disease cannot be removed and/or has spread.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Pre-procedural Imaging Evaluation

Pre-procedural imaging evaluation to assess suitability for cryoablation

Cryoablation Treatment

Participants receive ultrasound-guided percutaneous cryoablation for breast cancer

Follow-up

Participants are monitored for safety and effectiveness after cryoablation with follow-up imaging at 6 months, 12 months, and annually until 3 years post-procedure

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Cryoablation

How Is the Trial Designed?

Group I: Cryoablation Experimental Treatment 1 Intervention

Following pre-procedural imaging evaluation, patients will receive ultrasound-guided percutaneous cryoablation as part of their routine treatment of their breast cancer. Follow up imaging (if tolerated) will be performed at 6 months and 12 months and annually thereafter for until 3 years post-procedure. Data will be collected on patient demographics, disease characteristics, treatment, treatment complications, follow-up imaging, response (for 3 years post-procedure), and quality of life.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11912063/

Cryoablation for breast cancer: a narrative review of ... Cryoablation has been proven to be a unique and effective approach for treating early-stage, advanced, and inoperable breast cancer patients.

2. sirweb.org sirweb.org/for-press/cryoablation-highly-effective-for-breast-cancer-patients-with-large-tumors/

Cryoablation highly effective for breast cancer patients with ... When combined with hormonal therapy and radiation, patients can have nearly 100% of their tumors destroyed. If the tumors do grow, patients can ...

3. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2025.1469684/full

Cryoablation in the treatment of early breast cancer In breast cancer, cryoablation has demonstrated a complete ablation rate of 90%, indicating its effectiveness in achieving tumor control without ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1076633224004513

Defining Breast Cryoablation Treatment Success: A Guide ... Recent ICE3 trial of breast cryoablation for breast cancer demonstrated 98% success rate, similar to breast-conserving surgery. However, ICE3 and other ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.e13105

Percutaneous cryoablation of breast cancer metastases Patient data including demographics, cancer treatment history and outcomes were extracted by chart review after IRB approval.

6. eurradiolexp.springeropen.com eurradiolexp.springeropen.com/articles/10.1186/s41747-024-00515-4

Ultrasound-guided cryoablation of early breast cancer These studies concluded that cryoablation is an effective and safe treatment. Consistent with these literature data, in our pilot study ...

7. icecure-medical.com icecure-medical.com/blog/cryoablation-for-breast-cancer-evidence-to-date/

Cryoablation for Breast Cancer - Evidence to date The study concluded that cryoablation for early-stage breast cancer is an effective and safe treatment with excellent cosmetic outcomes and ...

8. onclive.com onclive.com/view/liquid-nitrogen-based-cryoablation-leads-to-high-rfs-rate-in-low-risk-early-stage-breast-cancer

Liquid Nitrogen–Based Cryoablation Leads to High RFS ... Liquid nitrogen–based cryoablation elicited a 5-year local RFS rate of 96.39% in patients with low-risk, early-stage breast cancer.

9. ajronline.org ajronline.org/doi/10.2214/AJR.24.31392

Cryoablation of Primary Breast Cancer in Patients Ineligible ... Results from the aforementioned trials have shown that cryoablation is a safe and efficacious alternative to surgery for treatment of breast cancer in this ...