Cryoablation for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of cryoablation for certain types of breast cancer. Cryoablation freezes and destroys cancer cells. The study will collect data on cancer recurrence rates and observe long-term health outcomes. It suits women aged 70 or older with a specific type of early-stage breast cancer, characterized by small, hormone-sensitive tumors. Participants should not show any signs of cancer spreading to the lymph nodes. As an unphased trial, this study allows participants to contribute to valuable research that could enhance future treatment options.
What prior data suggests that the ProSense® Cryoablation System is safe for treating low-risk early-stage breast cancer?
A previous study demonstrated that the ProSense® Cryoablation System showed promise for treating low-risk, early-stage breast cancer. Most side effects were minor, including swelling, bruising, and mild pain, and they typically resolved on their own. The study also found that only 3.1% of patients experienced cancer recurrence over five years. This suggests the treatment is generally well-tolerated and safe for older women with this type of breast cancer.12345
Why are researchers excited about this trial?
Unlike traditional treatments for low-risk, early-stage breast cancer, which typically involve surgery or radiation, the ProSense® Cryoablation System offers a minimally invasive alternative. This treatment uses extreme cold to precisely target and destroy cancer cells, potentially reducing recovery time and minimizing damage to surrounding healthy tissue. Researchers are excited about this approach because it could lead to fewer side effects and a quicker return to daily activities for patients, making it a promising option in the fight against breast cancer.
What evidence suggests that the ProSense® Cryoablation System is effective for low-risk early-stage breast cancer?
Studies have shown that the ProSense® Cryoablation System, which participants in this trial will receive, effectively treats low-risk, early-stage breast cancer, particularly in women aged 70 and older. Research indicates that cryoablation works best for tumors 1.5 cm or smaller. This method involves freezing cancer cells and has succeeded in 100% of certain breast cancers up to 2.5 cm. Specifically, a key study found that 96.39% of patients with this type of breast cancer did not experience a local recurrence within five years. Overall, these results suggest that cryoablation is a promising option for managing early-stage breast cancer in older women.25678
Are You a Good Fit for This Trial?
This trial is for women aged 70 or older with a single, small (1.5 cm or less), low-risk early-stage breast cancer that tests positive for estrogen and progesterone receptors but negative for HER2. The tumor must be visible on ultrasound, lymph nodes must not show signs of cancer, and participants need to be taking hormone therapy.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo the ProSense® Cryoablation procedure for local treatment of low-risk early-stage breast cancer
Follow-up
Participants are monitored for recurrence rates and other outcomes, including safety and effectiveness, for up to 5 years post-treatment
Long-term Outcomes Assessment
Linkage to claims data to assess long-term outcomes such as surgeries, imaging procedures, biopsies, and mortality
What Are the Treatments Tested in This Trial?
Interventions
- ProSense® Cryoablation System
Trial Overview
The study is testing the safety and effectiveness of ProSense® Cryoablation—a procedure that freezes and destroys breast tumors—used alongside standard hormone therapy in eligible patients. Researchers will track recurrence rates and long-term outcomes over five years.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
FDA-Approved cryoablation procedure for the indicated population
Find a Clinic Near You
Who Is Running the Clinical Trial?
IceCure Medical Ltd.
Lead Sponsor
Citations
IceCure Medical's ProSense® Cryoablation Granted FDA ...
"With the ProSense® Cryoablation System, we are giving women with low-risk, early-stage breast cancer the choice to freeze their cancer, not ...
Cryoablation for breast cancer: a narrative review of advances ...
cryoablation is most effective for early-stage, low-risk breast cancer patients, particularly when the tumor size is ≤1.5 cm. The procedure ...
US Food and Drug Administration
This study evaluated ProSenseTM's safety and efficacy in treating early-stage, low-risk breast cancer in women aged 60 and above.
4.
ctv.veeva.com
ctv.veeva.com/study/post-marketing-study-for-early-stage-low-risk-breast-cancer-treatment-using-prosense-r-cryoablationPost-Marketing Study for Early-Stage Low-Risk Breast Cancer ...
This clinical trial is designed to collect additional data on the safety and effectiveness of cryoablation when used as part of routine clinical ...
5.
evtoday.com
evtoday.com/news/four-studies-evaluate-icecures-prosense-cryoablation-system-to-treat-breast-cancerFour Studies Evaluate IceCure's ProSense Cryoablation ...
The key finding was that percutaneous cryoablation was successful in 100% of luminal cancers up to 2.5 cm. Additionally, complete tumoral ...
Cryoablation Without Excision for Early-Stage Breast Cancer
The ICE3 trial evaluated the safety and efficacy of cryoablation in women aged ≥60 years with low-risk, early-stage breast cancers, ...
7.
evtoday.com
evtoday.com/news/fda-authorizes-icecures-prosense-cryoablation-for-early-stage-breast-cancerFDA Authorizes IceCure's ProSense Cryoablation for Early ...
ICE3 results showed a 3.1% local recurrence rate at 5 years. Most adverse events, including edema, bruising, hematoma, and mild pain, resolved ...
Cryoablation: a less invasive choice for tumor destruction ...
5 year-results for the ICE3 clinical study provided evidence to assess the safety and efficacy for the ProSense® cryotherapy treatment of low-risk, early-stage ...
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