What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as chemotherapy, radiotherapy, and hormone therapy, are associated with a range of side effects. Chemotherapy can cause alopecia (hair loss), nausea, fatigue, and peripheral neuropathy. Radiotherapy often leads to skin irritation, fatigue, and in some cases, lymphedema. Hormone therapy may result in hot flashes, joint pain, and an increased risk of osteoporosis. Cryoablation, a less common treatment, primarily causes localized pain and swelling at the treatment site. Overall, while these treatments are effective, they come with a variety of side effects that can impact patients' quality of life.

What prior FDA approvals exist?

Cryoablation, which involves the destruction of cancer cells using extreme cold, is an emerging treatment for breast cancer. While specific FDA approvals for cryoablation in breast cancer are limited, other minimally invasive treatments have been approved. For instance, the FDA has approved various systemic therapies such as hormone therapies (e.g., tamoxifen, aromatase inhibitors), targeted therapies (e.g., trastuzumab for HER2-positive breast cancer), and immunotherapies (e.g., pembrolizumab). These treatments offer non-surgical options for managing breast cancer, similar to the minimally invasive nature of cryoablation.

What other types of research exist?

Promising novel alternatives to cryoablation for breast cancer treatment in 2024 include: 1) Targeted therapies such as HER2 inhibitors (e.g., trastuzumab) and CDK4/6 inhibitors (e.g., palbociclib), which specifically target cancer cell growth pathways. 2) Immunotherapy, including checkpoint inhibitors like pembrolizumab, which enhance the body's immune response against cancer cells. 3) Advanced surgical techniques, such as oncoplastic surgery, which combine tumor removal with cosmetic breast reconstruction. These alternatives provide diverse options for personalized treatment plans.

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Procedure

Cryoablation for Breast Cancer

N/A

Waitlist Available

Research Sponsored by IceCure Medical Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Estrogen receptor-positive, progesterone receptor-positive, HER2 negative

Diagnosis of invasive ductal breast carcinoma by core needle biopsy, meeting the following criteria:

Must not have

Presence of luminal B pathology

Presence of microinvasion, or invasive breast carcinoma with extensive intraductal component (EIC)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years for aes and up to 5 years for saes

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if using extreme cold to freeze and kill cancer cells can treat early-stage breast cancer without needing surgery. Cryoablation is a promising non-operative therapy for low-risk breast cancer, showing complete ablation of the target zone in early-stage cases.

Who is the study for?

This trial is for women aged 50 or older with early-stage breast cancer. Eligible participants have a single, small tumor (≤1.5 cm) that's visible on an ultrasound and has certain characteristics: it must be invasive ductal carcinoma, not too aggressive (Nottingham grade 1-2), hormone receptor-positive, HER2 negative, and suitable for cryoablation treatment.

What is being tested?

The Ice3 Trial is testing the effectiveness of using a technique called cryoablation with the Ice-Sense3TM/ProSenseTM system to treat low-risk small breast cancers without performing lumpectomy surgery. The goal is to see if this approach can prevent the cancer from coming back locally or spreading elsewhere.

What are the potential side effects?

Cryoablation may cause side effects such as pain at the treatment site, bruising, skin numbness or frostbite-like effects due to freezing temperatures used during the procedure. There might also be risks associated with not removing the tumor surgically.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is positive for estrogen and progesterone receptors but negative for HER2.

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I have been diagnosed with invasive ductal breast cancer through a biopsy.

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My tumor is 1.5 cm or smaller in all dimensions.

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I am 50 years old or older.

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My breast cancer is low or intermediate grade.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My breast cancer is classified as luminal B.

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My breast cancer has begun to spread beyond the ducts.

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I have received chemotherapy before or during surgery for breast cancer.

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I had surgery to remove or biopsy a lump in my breast for cancer diagnosis or treatment.

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My breast cancer is present in multiple areas of the same or both breasts.

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I have lobular carcinoma.

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My cancer is either not driven by estrogen and progesterone, or it is HER2 positive.

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My breast cancer is aggressive based on its Nottingham score.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years for aes and up to 5 years for saes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years for aes and up to 5 years for saes

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for aes and up to 5 years for saes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

local Inbreast Breast Tumor Recurrence (IBTR) rate

Secondary study objectives

Adverse events

Breast Cancer Survival.

Breast cosmetics satisfaction

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: single arm, open labelExperimental Treatment1 Intervention

Early stage Breast cancers up to 1.5cm

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ice-Sense3TM/ ProSenseTM

2014

N/A

~210

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cryoablation involves the application of extreme cold to destroy cancer cells by causing ice crystal formation within the cells, leading to cell membrane rupture and cell death. This minimally invasive method is particularly useful for small, localized tumors. Other common treatments include endocrine therapy, which blocks hormones that fuel certain breast cancers; chemotherapy, which uses cytotoxic drugs to kill rapidly dividing cells; and targeted therapy, which attacks specific molecules involved in cancer growth and spread. Understanding these mechanisms helps patients comprehend how treatments work, their potential side effects, and the rationale behind choosing a specific therapy based on their cancer type and stage.