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Cryoablation vs. Lumpectomy for Early Breast Cancer

This study is comparing two ways to treat early-stage breast cancer: cryoablation (freezing the tumor) and lumpectomy (surgically removing the tumor). The goal is to see if cryoablation is as safe and effective as lumpectomy for certain types of breast cancer. You might be able to join if you are a woman aged 50 or older with a specific type of invasive ductal carcinoma (ER+, Her-2 negative, grade 1 or 2, T1N0M0, 2 cm or less). The study will look at how often breast cancer comes back in the treated breast after 5 years, as well as complication rates and quality of life. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 120 participants. It will compare cryoablation to lumpectomy.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 5 years to assess for breast cancer recurrence.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05505643

Cryoablation vs Lumpectomy in T1 Breast Cancers

Recruiting
NAAges 50+InterventionalTreatment
Washington University School of Medicine
~120 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:Endocare SlimLine CryoprobeLumpectomy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety Lead-In: Number of treatment-related complications
Measured over Assessed from start of treatment through 30 days after cryoablation treatment (estimated to be 31 days)
+1 more outcome measured

Conditions

Breast Cancer
Breast Neoplasm

Explore related trials

Breast CarcinomaOncotype

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

  • Heather Garrett, M.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Heather Garrett, M.D.
[email protected]
636-916-9662
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Safety Lead-In: Number of treatment-related complicationsAssessed from start of treatment through 30 days after cryoablation treatment (estimated to be 31 days)

    Excessive adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0. They are defined as toxicities occurring within 30 days after the cryoablation procedure and are at least possibly related to the cryoablation. These include death, life-threatening adverse events, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or complications related to cryoablation which interfere with adjuvant therapy such that the adjuvant therapy cannot be performed at all or delayed for a period longer than 6 months or which result in unplanned mastectomy.

  • Randomized Controlled Trial: Ipsilateral breast cancer recurrence (IBTR) in the treated breast.At 5 years.

    IBTR defined from date of procedure to date of ipsilateral breast cancer recurrence, with the occurrence of ipsilateral breast tumor recurrence as the event and patients will be censored at the last follow-up.