Cryoablation for Early-Stage Breast Cancer

(DCIS Trial)

Overseen By Dennis R Holmes, M.D.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Glendale Adventist Medical Center d/b/a Adventist Health Glendale

Disqualifiers: Prior DCIS, Invasive breast cancer, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 1 day

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called cryoablation, which involves freezing breast tumors. The researchers aim to determine if this method can effectively treat early-stage invasive breast cancer and small areas of DCIS (a non-invasive breast condition) as a less invasive alternative to surgery. The trial seeks participants with a DCIS size of 2 cm or less, confirmed through a needle biopsy, who have never had breast cancer or certain treatments in the same breast before. As an unphased trial, it offers a unique opportunity to explore innovative treatment options for breast cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that cryoablation is safe for early-stage breast cancer?

Research has shown that cryoablation, a method of freezing tumors, is generally safe for treating early-stage breast cancer. In past studies, patients handled the procedure well, with few complications, and many expressed high satisfaction.

One study found that cryoablation successfully controlled tumors in 73% of cases, with no major complications. The appearance of the breast after treatment was also satisfactory. Another study indicated that cryoablation is a promising non-surgical option for early-stage breast cancer, with fewer health issues related to the procedure.

Overall, the safety data for cryoablation suggest it is a well-tolerated treatment option with minimal side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Cryoablation is unique because it offers a minimally invasive alternative to surgery for early-stage breast cancer, specifically DCIS (ductal carcinoma in situ). Unlike traditional surgical options, cryoablation uses extreme cold to destroy cancerous cells, which could potentially lead to fewer side effects and quicker recovery times. Researchers are excited about this treatment because it could make managing early-stage breast cancer less disruptive to patients' lives while still being effective.

What evidence suggests that cryoablation is effective for early-stage breast cancer?

Research has shown that cryoablation, a procedure that freezes tumors, works well for early-stage breast cancer. Studies indicate it successfully controls tumors in about 73% of cases without causing major problems. Patients find it safe, easy to handle, and are generally very satisfied. This trial tests cryoablation as an alternative to surgery for small areas of DCIS, a non-invasive type of breast cancer, with encouraging results. Overall, it offers a less invasive and more affordable option compared to traditional surgery. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with a condition called Ductal Carcinoma In Situ (DCIS) in the breast, who haven't had surgery or radiation on the same breast. They should not be pregnant or have been pregnant in the last 6 months and must have enough breast volume for cryoablation. The DCIS should span 2 cm or less as seen on mammography or MRI.

Inclusion Criteria

I have never had radiation therapy on the same breast.

Adequate breast volume and skin clearance to permit cryoablation as assessed by Dr. Holmes. This excludes males and females with breasts too small to allow safe cryoablation

I have never had breast cancer or DCIS in the same breast before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cryoablation to achieve complete ablation of DCIS

1 day

1 visit (in-person)

Follow-up

Participants are monitored for completeness of ablation and recurrence of DCIS

6 months

Post-cryoablation core biopsy at 6 months

Long-term follow-up

Participants are monitored for recurrence of invasive breast cancer

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Cryoablation

Trial Overview

The trial is testing cryoablation, which involves freezing tumor cells as an alternative to traditional surgery. It's being studied to see if it can completely destroy small areas of DCIS without needing surgical removal.

How Is the Trial Designed?

Group I: Cryoablation Experimental Treatment 1 Intervention

Phase I, single-arm study to evaluate the ability of cryoablation to achieve complete ablation of DCIS in the cryoablation zone of necrosis as a potential alternative to surgery.

Cryoablation is already approved in United States, European Union for the following indications:

Approved in United States as Cryoablation for:

• Liver cancer
• Kidney cancer
• Bone cancer
• Pain management

Approved in European Union as Cryoablation for:

• Liver cancer
• Kidney cancer
• Bone cancer
• Pain management

Who Is Running the Clinical Trial?

Glendale Adventist Medical Center d/b/a Adventist Health Glendale

Lead Sponsor

Trials

3

Recruited

1,200+

Helen Rey Breast Cancer Research Foundation

Collaborator

Trials

1

Recruited

30+

Doterra Healing Hands Foundation

Collaborator

Trials

1

Recruited

30+

California Oncology Research Institute

Collaborator

Trials

1

Recruited

30+

Published Research Related to This Trial

In a study involving 15 women with small breast nodules, percutaneous cryoablation effectively achieved complete necrosis of the treated lesions in 14 out of 15 cases, demonstrating its efficacy as a treatment option.

The procedure, guided by imaging techniques and performed by experienced operators, resulted in excellent oncological and cosmetic outcomes, highlighting its potential as a minimally invasive alternative to traditional surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous local ablation of unifocal subclinical breast cancer: clinical experience and preliminary results of cryotherapy. Manenti, G., Perretta, T., Gaspari, E., et al.[2022]

Percutaneous ultrasound-guided breast cryoablation is a safe and effective minimally invasive procedure that uses extreme cold to destroy targeted breast tissue, requiring only local anesthesia and taking less than 45 minutes.

The technique is specifically indicated for treating primary breast cancer, and the paper discusses the mechanism of cell death, procedural techniques, and expected follow-up imaging results after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Breast Cancer Cryoablation. Ward, RC., Lourenco, AP., Mainiero, MB.[2020]

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 for liver metastases from breast cancer showed a high technical success rate of 92% and an effectiveness rate of 87.1% at one month after treatment, indicating it is a promising option for local tumor control.

The procedure was found to be safe, with no major complications reported, and it preserved quality of life in patients, as evidenced by stable symptoms and functioning scales at three months post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous cryoablation of liver metastases from breast cancer: initial experience in 17 patients. Zhang, W., Yu, H., Guo, Z., et al.[2015]

This study aims to evaluate the safety of cryoablation in 10 patients with painful bone and soft tissue tumors, focusing on the prevalence of severe adverse events within 4 weeks post-treatment.

The effectiveness of cryoablation will also be assessed 4 weeks after the procedure, providing insights into its potential as a pain management option for patients who have not responded to other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Percutaneous Cryoablation in Patients with Painful Bone and Soft Tissue Tumors: A Single Center Prospective Study (SCIRO-1502). Iguchi, T., Sakurai, J., Hiraki, T., et al.[2017]

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 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]

CT-guided percutaneous cryoablation demonstrated a 100% efficacy rate for renal cell carcinoma lesions smaller than 7 cm, making it a promising treatment option for patients who may not be suitable for surgery.

The procedure had a technical success rate of 100% with manageable complications (18% incidence), all of which were reversible, and no patients experienced renal failure or significant changes in kidney function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of CT-guided percutaneous cryoablation for renal cell carcinoma. Georgiades, CS., Hong, K., Bizzell, C., et al.[2008]

Cryoablation for treating breast fibroadenomas was well tolerated in a study involving 310 procedures across 53 sites, with only minor complications reported immediately after the treatment.

At 6 and 12 months post-procedure, the majority of fibroadenomas showed significant volume reduction, excellent cosmetic outcomes, and high patient satisfaction, indicating the procedure's efficacy and acceptability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progressive adoption of cryoablative therapy for breast fibroadenoma in community practice. Edwards, MJ., Broadwater, R., Tafra, L., et al.[2004]

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]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11194206/

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1051044315006983

Percutaneous Image-Guided Cryoablation of Breast Cancer

Complete local tumor control was noted in 73% of patients (mean follow-up, 8 mo). No major complications were noted. The cosmetic outcome was satisfactory.

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39436590/

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Ultrasound-guided cryoablation was effective and safe in early BC patients. The procedure was well-tolerated, with low morbidity and high patient satisfaction.

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tcr.amegroups.org

tcr.amegroups.org/article/view/97072/html

Cryoablation for breast cancer: a narrative review of advances ...

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

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05218044

NCT05218044 | Cryoablation as a Minimally Invasive ...

Cryoablation or tumor freezing is a percutaneous, office-based procedure that is emerging as a minimally invasive, cost-effective alternative to surgery that is ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11496432/

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Our pilot study showed that ultrasound-guided cryoablation is a promising nonsurgical alternative for treating early-stage BC.

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US Food and Drug Administration

This study evaluated ProSense™'s safety and efficacy in treating early-stage, low-risk breast cancer in women aged 60 and above. The trial ...