Breast Cancer, Cancer of the Breast
Conditions
Brief summary
This is a subject registry study of patients who undergo cryoablation for their breast cancer after being determined not to be surgical candidates. Data collected as part of this registry will be used to assess the safety of percutaneous ultrasound-guided cryoablation in this population as well as provide long-term follow-up of subjects who received cryoablation.
Interventions
DEVICECryoablation
Takes place at single time point.
Sponsors
Washington University School of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligibility Criteria: * Diagnosis of breast cancer. * Mass must be visible on ultrasound and \> 5 mm from skin. * Not undergoing surgery, because: * Patient has a medical condition that would not allow sedation or general anesthesia * Surgery is not clinically indicated due to unresectable and/or metastatic disease * Surgery is not clinically indicated for another reason * Patient declines surgery * At least 18 years old. * Able to understand and willing to sign an IRB-approved written informed consent document.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who are free of serious treatment related complications per CTCAE v 5.0 | Through 3 year follow-up |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients who demonstrate progression-free survival (PFS) | At 3 year follow-up |
| Proportion of patients who demonstrate disease-free survival (DFS) | At 3 year follow-up |
| Proportion of patients who demonstrate overall survival (OS) | At 3 year follow-up |
Countries
United States
Contacts
CONTACTHeather Garrett, M.D.
PRINCIPAL_INVESTIGATORHeather Garrett, M.D.
Washington University School of Medicine
Outcome results
None listed