Cryoablation vs Lumpectomy for Early Stage Breast Cancer

(COOL-IT Trial)

Recruiting at 1 trial location

Overseen By Heather Garrett, M.D.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: BRCA mutation, Prior breast cancer, Pregnant, others

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

Compensation: Varies

Number of Visits: 8

Duration: Varies based on procedure

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for early-stage breast cancer by freezing the tumor, a process known as cryoablation, using the Endocare SlimLine Cryoprobe. The researchers aim to determine if this method is as effective and safe as the standard surgery, lumpectomy, in controlling the disease and improving quality of life. Women with a specific type of breast cancer, where the tumor is small (2 cm or less) and visible on an ultrasound, may be suitable candidates. The trial will compare the outcomes of cryoablation and lumpectomy to identify which offers better results for patients. As an unphased trial, it provides patients the opportunity to explore innovative treatments that could enhance their quality of life.

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 early stage breast cancer?

Studies have shown that cryoablation, which uses extreme cold to destroy cancer cells, is safe for treating small breast tumors. Research suggests this method works well for early-stage breast cancer, and patients usually tolerate it well. Side effects are few and generally minor, such as bruising or swelling at the treatment site.

In contrast, lumpectomy, the standard surgery to remove a breast tumor, is also generally safe but requires more extensive surgery and a longer recovery time. Both treatments have been thoroughly studied, and evidence shows they are safe options for patients with early-stage breast cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about cryoablation for early-stage breast cancer because it offers a less invasive alternative to traditional surgery like lumpectomy. Cryoablation uses extreme cold to destroy cancer cells, which can be done with local anesthesia and real-time ultrasound guidance, potentially minimizing recovery time and reducing surgical risks. This method also allows for precise targeting of the tumor, preserving more of the surrounding healthy tissue. This approach could revolutionize treatment by making it less daunting and more accessible for patients.

What evidence suggests that this trial's treatments could be effective for early stage breast cancer?

Research has shown that cryoablation, one of the treatments studied in this trial, effectively treats early-stage breast cancer. This method destroys cancer cells by freezing the tumor. Studies have found cryoablation to be a promising option for patients with early-stage breast cancer, offering an alternative to traditional surgery. Participants in this trial may receive cryoablation, which often results in less scarring and fewer complications than surgery. For those exploring their options, cryoablation might offer effective disease control and potentially improve quality of life compared to lumpectomy, the other treatment arm in this trial. ^{1 2 3 4 6}

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?

This trial is for women over 50 with early-stage, low-risk breast cancer (T1N0M0, Luminal A type, ER/PR positive, Her-2 negative) that's visible on ultrasound and not too close to the skin or chest muscles. Participants must have a specific Oncotype score if applicable and can't be pregnant or breastfeeding. They should not have had breast cancer before, no BRCA mutations, no electrical implants incompatible with MRI, and no allergy to local anesthetics.

Inclusion Criteria

My breast cancer has an Oncotype score below 26.

My breast cancer is early stage, hormone receptor positive, HER2 negative, and not aggressive.

My tumor can be seen on an ultrasound and is not too close to my skin or chest muscles.

Exclusion Criteria

My cancer has spread to the lymph nodes in my armpit.

I have a BRCA 1 or BRCA 2 gene mutation.

I have had breast cancer before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Lead-In

Initial safety assessment of cryoablation procedure

31 days

1 visit (in-person)

Treatment

Participants receive either cryoablation or lumpectomy

Varies based on procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

6 month MRI and yearly MRI/mammography

What Are the Treatments Tested in This Trial?

Interventions

• Endocare SlimLine Cryoprobe
• Lumpectomy

Trial Overview The study compares cryoablation—a technique of freezing tumors—with lumpectomy—the standard surgical removal of tumors—in treating T1 stage breast cancer. It aims to assess which method offers better disease control and quality of life while monitoring safety and complication rates.

How Is the Trial Designed?

Group I: Rescue Arm: Lumpectomy Experimental Treatment 1 Intervention

If there is evidence of residual or recurrent tumor on follow-up imaging evaluation (6 month MRI (if can tolerate) and yearly MRI/mammography), patients in the cryoablation safety lead-in and who were randomized to receive cryoablation only will be crossed over to receive a rescue lumpectomy followed by adjuvant treatment based on standard of care.

Group II: Cryoablation - Safety Lead In Experimental Treatment 1 Intervention

Patients will be treated with cryoablation (Day 1) using the Endocare SlimLine Cyroprobe followed by adjuvant treatment.

Group III: Cryoablation Experimental Treatment 1 Intervention

Patients will be treated with cryoablation using the Endocare SlimLine Cyroprobe under real time ultrasound guidance and local anesthesia. The cryoablation consists of a 10 minute freeze phase followed by a 10 minute passive thaw, and ends with a second 10 minute freeze cycle. The freeze-thaw-freeze times may be adjusted at the physician's discretion depending on tumor size.

Group IV: Lumpectomy Active Control 1 Intervention

Lumpectomy will be performed under general anesthesia as per standard operative procedures at Washington University and Siteman Cancer Center.

Endocare SlimLine Cryoprobe is already approved in European Union, United States for the following indications:

Approved in European Union as Cryoablation Therapy for:

• Early-stage breast cancer
• Benign breast tumors (fibroadenomas)

Approved in United States as Cryoablation Therapy for:

• Fibroadenoma (benign breast tumors)
• Investigational for breast cancer

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

The Foundation for Barnes-Jewish Hospital

Collaborator

Trials

43

Recruited

6,600+

Varian Medical Systems

Industry Sponsor

Trials

63

Recruited

3,700+

Dow R. Wilson

Varian Medical Systems

Chief Executive Officer since 2012

MBA from Dartmouth's Amos Tuck School of Business, BA from Brigham Young University

Dr. Deepak Khuntia

Varian Medical Systems

Chief Medical Officer since 2020

MD from the University of Cambridge, PhD from the University of Leicester

Published Research Related to This Trial

In a phase II trial involving 99 patients with early-stage breast cancer, cryoablation successfully ablated 75.9% of tumors, indicating its potential as an effective non-surgical treatment option.

The study also found that magnetic resonance imaging (MRI) had a negative predictive value of 81.2% for detecting residual cancer, suggesting it could be a useful tool in assessing treatment success after cryoablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma: Results from ACOSOG (Alliance) Z1072. Simmons, RM., Ballman, KV., Cox, C., et al.[2022]

In a study involving 102 patients and 124 lesions across 12 centers, the Tailored Freeze technique for cryoablation showed a median tumor volume reduction of 91% after 12 months, with 73% of tumors becoming nonpalpable.

The safety profile of cryoablation was excellent, with only minor complications reported, and 92% of patients expressed good to excellent satisfaction with the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryoablation of benign breast tumors: evolution of technique and technology. Caleffi, M., Filho, DD., Borghetti, K., et al.[2006]

Percutaneous breast cancer cryoablation demonstrated a complete local tumor control rate of 73% over an average follow-up period of 8 months, indicating its efficacy, especially for small ductal tumors under 15 mm.

The procedure was found to be safe, with no major complications reported and satisfactory cosmetic outcomes, suggesting it is a viable option for breast cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous Image-Guided Cryoablation of Breast Cancer: A Systematic Review. Lanza, E., Palussiere, J., Buy, X., et al.[2022]

Cryoablation is a safe and effective primary therapy for breast fibroadenoma, providing durable results that can be replicated in community practices, making it a patient-friendly alternative to traditional heat-based treatments.

Cryolocalization, a new application of cryotechnology, helps create a clear frozen boundary around tumors, which may reduce the chances of leaving cancerous tissue behind during lumpectomy procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryoablation and cryolocalization in the management of breast disease. Whitworth, PW., Rewcastle, JC.[2007]

Cryoablation is a minimally invasive technique for treating breast cancer that allows for breast conservation and is well-visualized during the procedure due to ice formation.

This case study highlights the potential of CT-guided cryoablation to treat breast cancer with lymph node metastasis effectively, using only local anesthesia and/or mild sedation, making it a cost-effective outpatient option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CT-guided cryoablation of both breast cancer and lymph node axillary metastasis. Pusceddu, C., Capobianco, G., Meloni, F., et al.[2020]

Percutaneous cryoablation of breast tumors in 17 patients with metastatic breast cancer was technically successful and resulted in complete regression of the primary lesions in 15 patients, demonstrating its efficacy for local control of tumors.

The procedure was well-tolerated with low complication rates, providing immediate and long-term pain relief for patients, making it a viable option for palliative care in those with limited treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous cryoablation of breast tumours in patients with stable metastatic breast cancer: safety, feasibility and efficacy. Beji, H., Pilleul, F., Picard, R., et al.[2019]

Cryoablation was successfully used to treat two nonpalpable breast cancers in an 85-year-old woman, demonstrating its potential as a treatment option for breast tumors.

The patient was monitored for 18 months using mammograms, ultrasounds, and histological evaluations, indicating that cryoablation can be safely followed by long-term observation without immediate need for tumor resection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unresected Breast Cancer: Evolution of Imaging Findings Following Cryoablation. Bergin, JT., Sisney, GA., Lee, FT., et al.[2020]

Cryoablation is a safe and effective treatment for early-stage breast cancer, particularly for tumors smaller than 1.5 cm, with successful destruction rates for cancers under 1.0 cm.

The presence of noncalcified ductal carcinoma-in-situ (DCIS) can lead to treatment failures, so cryoablation is recommended only for invasive ductal carcinoma with less than 25% DCIS in the biopsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryosurgery of breast cancer. Niu, L., Zhou, L., Xu, K.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05505643

Cryoablation vs Lumpectomy in T1 Breast Cancers This trial studies the efficacy and safety of cryoablation in patients with low risk, early stage breast cancer. Cryoablation is a method of killing a tumor ...

2. 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.

3. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/356058

Cryoablation vs Lumpectomy in T1 Breast Cancers This trial studies the efficacy and safety of cryoablation in patients with low risk, early stage breast cancer. Cryoablation is a method of ...

4. siteman.wustl.edu siteman.wustl.edu/clinical-trial/202302017/

COOL-IT: Cryoablation vs Lumpectomy in T1 Breast Cancers This trial studies the efficacy and safety of cryoablation in patients with low risk, early stage breast cancer. Cryoablation is a method of killing a tumor ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12130041/

Cryoablation in the treatment of early breast cancer Cryoablation has emerged as a promising local treatment technique for early breast cancer, garnering significant interest in recent years.

6. withpower.com withpower.com/trial/phase-breast-cancer-10-2022-0af39

Cryoablation vs Lumpectomy for Early Stage Breast Cancer Research shows that cryoablation, a treatment that uses extreme cold to destroy cancer cells, is safe and effective for small breast tumors, with studies noting ...