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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 14 days post surgery

Awards & highlights

Study Summary

This trial is studying whether cryoablation therapy, which kills tumor cells by freezing them, is an effective treatment for 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of Complete Tumor Ablation

Secondary outcome measures

Adverse Events

Negative Predictive Value of MRI

Pain Assessment

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

~12270

cryosurgery

2007

Completed Phase 3

~110

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor

512 Previous Clinical Trials

217,539 Total Patients Enrolled

74 Trials studying Breast Cancer

40,044 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,054 Total Patients Enrolled

939 Trials studying Breast Cancer

1,543,261 Patients Enrolled for Breast Cancer

Rache M. Simmons, MDStudy ChairWeill Medical College of Cornell University

1 Previous Clinical Trials

664 Total Patients Enrolled

1 Trials studying Breast Cancer

664 Patients Enrolled for Breast Cancer

Media Library

Cryoablation Therapy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT00723294 — Phase 2

Breast Cancer Research Study Groups: Treatment (cryoablation)

Breast Cancer Clinical Trial 2023: Cryoablation Therapy Highlights & Side Effects. Trial Name: NCT00723294 — Phase 2

Cryoablation Therapy (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00723294 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many different hospitals are participating in this clinical trial?

"Currently, this study is recruiting patients at 16 different sites. These locations include Indianapolis, Wynnewood and Cincinnati, as well as other places. If you enroll in the study, it may be helpful to choose the clinic nearest you to minimize travel requirements."

Answered by AI

Has FDA cleared traditional surgery as a treatment method?

"This surgical intervention is in Phase 2 clinical trials, meaning that while there is some evidence supporting its safety, none exists yet to suggest efficacy. Our team has rated it a 2."

Answered by AI

Are people still being accepted into the research program?

"No, this particular clinical trial is not seeking patients at the moment. Although, it is worth mentioning that there are 2698 other trials with open recruitment. This study was first posted on September 1st, 2008 and received its last update June 30th, 2017."

Answered by AI