Actively Recruiting
Cryoablation vs Lumpectomy in T1 Breast Cancers
Led by Washington University School of Medicine · Updated on 2026-02-27
120
Participants Needed
1
Research Sites
473 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
T
The Foundation for Barnes-Jewish Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cryoablation vs Lumpectomy in T1 Breast Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of invasive ductal carcinoma of the breast (ER-, Her-2 negative) that is grade 1 or 2 with intraductal component less than 25%. Tumor must be T1N0M0 (2 cm or less).
- If DCIS is present, it should be less than 25% of the tumor and contiguous with the invasive ductal carcinoma.
- Oncotype testing required for certain tumor sizes; score must be less than 26 to participate.
- At least 50 years old.
- Negative ipsilateral axillary assessment by ultrasound, sentinel lymph node biopsy, or percutaneous axillary node biopsy with no signs of metastatic disease.
- Able to understand and willing to sign informed consent.
You will not qualify if you...
- Indication for neoadjuvant chemotherapy.
- Past history of breast cancer.
- Previous breast augmentation.
- Allergy to local anesthetics.
- Pregnant or lactating; women of childbearing potential must have a negative pregnancy test within 14 days before joining.
- Tumoral involvement of skin or chest wall.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
H
Heather Garrett, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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