Cryoablation - Safety Lead In for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Washington University School of Medicine, Saint Louis, MO
Breast Cancer+2 More
Endocare SlimLine Cryoprobe - Device
Eligibility
18+
Female
What conditions do you have?
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Study Summary

This trial studies the efficacy and safety of cryoablation in patients with low risk, early stage breast cancer. Cryoablation is a method of killing a tumor by freezing it. The standard approach for patients with this kind of cancer is a lumpectomy. This study will review the safety of the cryoablation procedure initially, followed by comparing cryoablation to lumpectomy in order to see if the cryoablation results in better disease control, complication rates, and quality of life.

Eligible Conditions

  • Breast Cancer
  • Neoplasms, Breast

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: At 5 years.

Day 31
Proportion of patients who are free of serious treatment-related complications
Safety Lead-In: Number of treatment-related complications
At 5 years.
Randomized Controlled Trial: Ipsilateral breast cancer recurrence (IBTR) in the treated breast.
Through 5 years.
Overall survival (OS)
Proportion of patients who demonstrate disease-free survival (DFS)

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Lumpectomy
1 of 3
Cryoablation - Safety Lead In
1 of 3
Cryoablation
1 of 3
Active Control
Experimental Treatment

256 Total Participants · 3 Treatment Groups

Primary Treatment: Cryoablation - Safety Lead In · No Placebo Group · N/A

Cryoablation - Safety Lead In
Device
Experimental Group · 1 Intervention: Endocare SlimLine Cryoprobe · Intervention Types: Device
Cryoablation
Device
Experimental Group · 1 Intervention: Endocare SlimLine Cryoprobe · Intervention Types: Device
Lumpectomy
Procedure
ActiveComparator Group · 1 Intervention: Lumpectomy · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 5 years.
Closest Location: Washington University School of Medicine · Saint Louis, MO
Photo of washington university school of medicine  1Photo of washington university school of medicine  2Photo of washington university school of medicine  3
2004First Recorded Clinical Trial
55 TrialsResearching Breast Cancer
1465 CompletedClinical Trials

Eligibility Criteria

Age 18+ · Female Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a Oncotype score of at least 26.
You have a minimum age of 50 years.
You are able to understand and willing to sign an IRB-approved written informed consent document.
You have invasive ductal carcinoma of the breast of luminal type A (ER/PR positive, Her-2 negative) that is grade 1 or 2 with intraductal component <25%
The mass must be visible on ultrasound and >5 mm from skin and chest wall muscles.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.