Cryoablation Compared to Lumpectomy for the Treatment of Patients with Breast Cancer, COOL-IT Trial

PRIMARY OBJECTIVES:

I. To assess the safety of percutaneous ultrasound-guided cryoablation of T1 breast cancers at Washington University. (Safety Lead-in)

II. To estimate the ipsilateral breast tumor recurrence (IBTR) rate at 5 years after ultrasound-guided percutaneous cryoablation versus (vs.) lumpectomy as primary source control followed by standard adjuvant therapy (Randomized Controlled Trial)

SECONDARY OBJECTIVES:

I. To demonstrate the safety of percutaneous ultrasound-guided cryoablation of T1 breast cancers in an outpatient setting.

II. To compare disease-free survival (DFS) and overall survival (OS) including breast cancer survival in each arm.

EXPLORATORY OBJECTIVES:

I. To quantify the proportion of patients undergoing mastectomy on the treated side at 5 years in each arm.

II. To assess the crossover rate in the cryoablation arm after incomplete ablation.

III. To assess the re-excision rate in the lumpectomy arm.

IV. To describe patient quality of life (QoL) before and after the procedure by BREAST-Q modules – “breast cancer core scale – psychosocial well-being” and “physical well-being: chest.”

V. To describe patient and physician satisfaction with cosmesis at 6 months and then annually for 5 years quantitatively by the BREAST-Q module “satisfaction with breasts” (patient).

VI. To assess the utility of pre and post procedural breast magnetic resonance imaging (MRI) in both arms.

VII. To assess procedural cost comparison of cryoablation vs. lumpectomy.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo ultrasound-guided cryoablation on study. Patients also undergo breast MRI or contrast-enhanced mammography (CEM) at baseline and follow up, and undergo mammography during follow up. Patients with remaining or returned tumor on follow up imaging will be crossed over to Arm II to undergo lumpectomy.

ARM II: Patients undergo lumpectomy on study. Patients also undergo breast MRI or CEM at baseline and follow up, and undergo mammography during follow up.

Patients are followed up at 6 and 12 months and then every 12 months thereafter until 5 years post-procedure or until death, whichever occurs first.