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Cryoablation vs Lumpectomy in T1 Breast Cancers

Recruiting

COOL-IT: Cryoablation vs Lumpectomy in T1 Breast Cancers: A Randomized Controlled Trial With Safety Lead-in

Who can join

Ages 50 and older · Women

Full eligibility criteria
Inclusion Criteria:

* Diagnosis of invasive ductal carcinoma of the breast (ER , Her-2 negative) that is grade 1 or 2 with intraductal component \<25%. Must be T1N0M0 (2 cm or less).
* If DCIS is present in the biopsy specimen it should be \<25% of the tumor and should be contiguous with the IDC. (i.e. DCIS should not be a separate tumor from the IDC).
* Oncotyping will be performed on T1b+Allred\<6/8 and T1c tumors. Oncotype score in this subset of patients must be \<26 to be included in the trial.
* At least 50 years of age.
* Negative ipsilateral axillary assessment as determined either by (1) negative axillary ultrasound (2) negative sentinel lymph node biopsy or (3) negative percutaneous axillary node biopsy with no further clinical or imaging concern for nodal metastatic disease.
* Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

* Indication for neoadjuvant chemotherapy.
* Prior history of breast cancer.
* Breast augmentation.
* Allergy to local anesthetics.
* Pregnant or lactating. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
* Tumoral involvement of skin or chest wall.

About the study

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.

What is being tested

Sponsor: Washington University School of Medicine · Participants: 120 · Started: Apr 3, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT05505643

Locations in the U.S.

MissouriWashington University School of Medicine, St Louis

Conditions

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.