What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as chemotherapy, radiotherapy, and cryoablation therapy, have various side effects. Chemotherapy can cause hair loss, peripheral neuropathy, fatigue, nausea, and increased infection risk. Radiotherapy may lead to skin irritation, fatigue, and long-term risks like radiation dermatitis and secondary cancers. Cryoablation therapy, which involves freezing tumor cells, is generally well-tolerated but can cause localized pain, swelling, and potential damage to surrounding tissues. These side effects vary in severity and frequency among patients.

What prior FDA approvals exist?

Cryoablation therapy, which involves freezing tumor cells, is being studied as a treatment for invasive ductal breast cancer. While specific FDA approvals for cryoablation in breast cancer are not detailed, other FDA-approved treatments for breast cancer include chemotherapy agents like anthracyclines and taxanes, targeted therapies such as trastuzumab for HER2-positive breast cancer, and hormone therapies like tamoxifen and aromatase inhibitors for hormone receptor-positive breast cancer. These treatments have been pivotal in managing various subtypes of breast cancer.

What other types of research exist?

Promising novel alternatives to cryoablation therapy for breast cancer patients in 2024 include: 1) Immunotherapy, such as PD-1/PD-L1 inhibitors, which enhance the body's immune response against cancer cells. 2) Targeted therapy, including PARP inhibitors for patients with BRCA mutations, which interfere with cancer cell DNA repair mechanisms. 3) Minimally invasive techniques like radiofrequency ablation, which uses heat to destroy tumor cells. These alternatives offer different mechanisms of action and may be suitable based on individual patient profiles and tumor characteristics.

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Cryoablation Therapy for Breast Cancer

Phase 2

Waitlist Available

Research Sponsored by Alliance for Clinical Trials in Oncology

Eligibility Criteria Checklist

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

Must have

Adequate breast size for safe cryoablation. Male breast cancer patients and female breast cancer patients with breasts too small to allow safe cryoablation are not eligible

Unifocal primary invasive ductal breast carcinoma diagnosed by core needle biopsy

Must not have

Patients with lobular carcinoma, multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, or DCIS with microinvasion

Prior or planned neoadjuvant chemotherapy for breast cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 14 days post surgery

Awards & highlights

No Placebo-Only Group

Summary

This study is evaluating whether cryoablation therapy is effective in treating patients with invasive ductal breast cancer.

Who is the study for?

This trial is for individuals with invasive ductal breast cancer confirmed by biopsy, where the tumor is primarily one type of tissue and not larger than 2.0 cm. Participants must not be pregnant or breastfeeding, have no history of similar cancer in the same breast, and should not have received or plan to receive chemotherapy before surgery.

What is being tested?

The study is examining cryoablation therapy—a technique that freezes and destroys tumor cells—as a potential treatment for patients with invasive ductal breast cancer. It's being compared to conventional surgical methods in this phase II trial.

What are the potential side effects?

Cryoablation may cause local pain, redness, bruising at the treatment site, risk of infection, skin numbness or scarring. Conventional surgery could lead to typical surgical risks like bleeding, infection, anesthesia complications and longer recovery time.

Eligibility Criteria

Inclusion Criteria

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

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My breast size is suitable for safe cryoablation treatment.

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

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I have not had, nor am I planning to have, initial chemotherapy for breast cancer.

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My tumor is mostly not made up of duct-like structures.

Exclusion Criteria

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

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My breast cancer is lobular, multifocal, or has spread within the same breast.

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I have had or will have chemotherapy before surgery for breast cancer.

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My tumor is larger than 2.0 cm.

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I have a tumor in the same breast as before.

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I had surgery to remove or examine a lump in my breast for cancer.

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My tumor is more than 25% made up of ductal cells.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 14 days post surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 14 days post surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 days post surgery for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Rate of Complete Tumor Ablation

Secondary study objectives

Negative Predictive Value of MRI

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: Treatment (cryoablation)Experimental Treatment2 Interventions

A cryoprobe is inserted percutaneously under ultrasound guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively. Patients undergo surgical resection and sentinel lymph node biopsy and/or axillary dissection within 28 days after completion of cryoablation. Patients complete the Brief Pain Inventory before and after cryoablation and after surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

therapeutic conventional surgery

2003

Completed Phase 3

~12900

cryosurgery

2007

Completed Phase 3

~110

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 therapy treats breast cancer by freezing and destroying tumor cells, which can be particularly useful for patients seeking less invasive options. Other common treatments include surgery, which physically removes the tumor; chemotherapy, which uses drugs to kill rapidly dividing cancer cells; radiation therapy, which uses high-energy rays to target and kill cancer cells; hormone therapy, which blocks hormones that fuel certain cancers; and targeted therapy, which attacks specific molecules involved in cancer growth. Understanding these mechanisms helps patients and doctors choose the most effective treatment plan tailored to the cancer's characteristics and the patient's needs.

Precision Oncology Framework for Investigation of Exercise As Treatment for Cancer.