Cryoablation - Safety Lead In for Breast Cancer
Phase-Based Progress Estimates
Effectiveness
Safety
Washington University School of Medicine, Saint Louis, MO
Breast Cancer+2 More
Endocare SlimLine Cryoprobe - DeviceEligibility
18+
Female
What conditions do you have?
Select
Eligibility
18+
Female
What conditions do you have?
Select
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
Other trials for Breast Cancer
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
Other trials for Breast Cancer
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: DeviceCryoablation
Device
Experimental Group · 1 Intervention: Endocare SlimLine Cryoprobe · Intervention Types: DeviceLumpectomy
Procedure
ActiveComparator Group · 1 Intervention: Lumpectomy · Intervention Types: ProcedureTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 5 years.
Closest Location: Washington University School of Medicine · Saint Louis, MO
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 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.
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Conditions
Cancer Related
Treatments