Cryoablation vs Lumpectomy in T1 Breast Cancers

Official title

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

Overview

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.

Interventions

• Device Endocare SlimLine Cryoprobe
  The Endocare(TM) SlimLine (TM) Cryoprobe is a single use, disposable device designed for use with Endocare Cryocare Surgical Systems. Endocare cryoprobes are designed to deliver cold temperatures for cryoablation using high-pressure argon gas circulated through the cryoprobe, followed by active thawing using helium gas. The Cryocare CS Surgical System is intended for use in open, minimally invasive, or endoscopic surgical procedures in the areas of general surgery, urology, gynecology, oncology
• Procedure Lumpectomy
  Patients randomized to cryoablation who experience disease recurrence may undergo crossover to lumpectomy.

Primary outcome measures

• Safety Lead-In: Number of treatment-related complications [Time frame: Assessed from start of treatment through 30 days after cryoablation treatment (estimated to be 31 days)]
• Randomized Controlled Trial: Ipsilateral breast cancer recurrence (IBTR) in the treated breast. [Time frame: At 5 years.]

Secondary outcome measures (3)

• Proportion of patients who are free of serious treatment-related complications [Time frame: Assessed from start of treatment through 30 days after cryoablation treatment (estimated to be 31 days)]
• Proportion of patients who demonstrate disease-free survival (DFS) [Time frame: Through 5 years.]
• Overall survival (OS) [Time frame: Through 5 years.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Washington University School of Medicine — St Louis

Identifiers

NCT: NCT05505643 · 202302017

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗