What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as chemotherapy, radiotherapy, and surgery, have a range of side effects. Chemotherapy often leads to alopecia (hair loss), fatigue, nausea, peripheral neuropathy, and increased risk of infections. Radiotherapy can cause skin irritation, fatigue, and lymphedema. Surgical options like lumpectomy or mastectomy may result in pain, infection, and lymphedema. Cryoablation, a less common treatment that involves freezing the tumor, generally has fewer side effects but can include localized pain, swelling, and potential damage to surrounding tissues. Each treatment's side effects vary in severity and frequency among patients.

What prior FDA approvals exist?

The FDA has approved various treatments for breast cancer, including surgical options like lumpectomy and mastectomy, systemic therapies such as chemotherapy, hormone therapy, and targeted therapies like trastuzumab for HER2-positive breast cancer. While cryoablation is being studied for its efficacy and safety in early-stage breast cancer, it is not yet a standard FDA-approved treatment. Other minimally invasive techniques, such as radiofrequency ablation and focused ultrasound, are also under investigation but have not yet received widespread FDA approval for breast cancer treatment.

What other types of research exist?

Promising novel alternatives to cryoablation for breast cancer patients include: 1) Immunotherapy, such as checkpoint inhibitors (e.g., pembrolizumab) which enhance the body's immune response against cancer cells. 2) Targeted therapy, including HER2 inhibitors (e.g., trastuzumab) for HER2-positive breast cancer. 3) PARP inhibitors (e.g., olaparib) for patients with BRCA mutations. 4) Advanced radiation techniques like stereotactic body radiotherapy (SBRT) which precisely targets tumors with minimal damage to surrounding tissue. These alternatives offer new avenues for effective treatment with potentially improved outcomes.

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Cryoablation

Cryoablation vs Lumpectomy for Early Stage Breast Cancer (COOL-IT Trial)

N/A

Recruiting

Led By Heather Garrett, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

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

Must have

Oncotyping will be performed on T1b+Allred<6/8 and T1c tumors. Oncotype score in this subset of patients must be <26 to be included in the trial.

Mass must be visible on ultrasound and >5 mm from skin and chest wall muscles.

Must not have

Positive axillary lymph nodes as assessed by axillary ultrasound, axillary sampling, or axillary sentinel node procedure.

Presence of BRCA 1 and/or BRCA 2 mutation.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 5 years.

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the safety and effectiveness of cryoablation, a method that freezes and kills cancer cells, in patients with low risk, early stage breast cancer. It aims to see if cryoablation can be a better alternative to the usual surgery. Cryoablation has been successfully used to treat various types of solid tumors, including breast carcinomas, and is considered a less invasive alternative to surgical treatment.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from cryoablation may include pain at the treatment site, bruising or bleeding under the skin, infection risk at the probe insertion point. Lumpectomy might cause temporary swelling or tenderness in the breast area as well as risks associated with surgery such as infection.

Eligibility Criteria

Inclusion Criteria

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

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My breast cancer has an Oncotype score below 26.

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

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

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I am 50 years old or older.

Exclusion Criteria

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

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

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I have a BRCA 1 or BRCA 2 gene mutation.

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I have had breast cancer before.

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My scans show DCIS outside the area planned for treatment.

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My doctor recommends chemotherapy before surgery.

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I have had breast augmentation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 5 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 5 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 5 years. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Randomized Controlled Trial: Ipsilateral breast cancer recurrence (IBTR) in the treated breast.

Safety Lead-In: Number of treatment-related complications

Secondary study objectives

Overall survival (OS)

Proportion of patients who are free of serious treatment-related complications

Proportion of patients who demonstrate disease-free survival (DFS)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Rescue Arm: LumpectomyExperimental Treatment1 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 InExperimental Treatment1 Intervention

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

Group III: CryoablationExperimental Treatment1 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: LumpectomyActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lumpectomy

2017

Completed Phase 2

~740

0 / 10Eligibility 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 treats breast cancer by freezing the tumor, causing ice crystals to form inside the cancer cells, which disrupts cell membranes and induces cell death. This method is minimally invasive and aims to preserve surrounding healthy tissue, potentially leading to fewer complications and a quicker recovery compared to traditional surgery. Lumpectomy, another common treatment, involves surgically removing the tumor and a small margin of surrounding tissue, aiming to eliminate cancer while conserving as much of the breast as possible. Chemotherapy uses drugs to kill rapidly dividing cancer cells throughout the body, which is crucial for treating metastatic or high-risk cancers. Hormone therapy targets hormone receptor-positive breast cancers by blocking hormones like estrogen that fuel cancer growth. Understanding these mechanisms helps patients and doctors choose the most appropriate treatment based on the cancer's characteristics and the patient's overall health and preferences.