Cryoablation vs Lumpectomy in T1 Breast Cancers

Not Applicable

Recruiting

• Conditions: Breast Cancer; Breast Neoplasm

• Registration Number: NCT05505643
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-15
• Study First Submitted QC: 2022-08-15
• Study First Posted: 2022-08-18
• Study Start: 2024-04-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-24
• Primary Completion: 2034-04-30
• Study Completion: 2034-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 256

Inclusion Criteria

• Diagnosis of 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%. Must be T1N0M0 (2 cm or less).
• 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.
• Mass must be visible on ultrasound and >5 mm from skin and chest wall muscles.
• 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.
• DCIS present beyond the proposed ablation zone on MRI, mammography, or ultrasound.
• Positive axillary lymph nodes as assessed by axillary ultrasound, axillary sampling, or axillary sentinel node procedure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.
Safety Lead-In: Number of treatment-related complications	Assessed 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.

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	Through 5 years.	OS is defined from date of procedure to date of death or date of last follow up if none of the recurrence events occur.
Proportion of patients who are free of serious treatment-related complications	Assessed 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.
Proportion of patients who demonstrate disease-free survival (DFS)	Through 5 years.	DFS is defined as the time from procedure to time of ipsilateral recurrence, contralateral recurrence, regional recurrence or distant metastasis, or date of last follow-up if none of the recurrence events occur.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States