Clinical trial NCT05505643: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Breast Neoplasm
Keywords: breast cancer
cryoablation
lumpectomy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: The Foundation for Barnes-Jewish Hospital
name: Varian Medical Systems
First posted: 2022-08-18
Enrollment: 256
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The initial 20 participants will be enrolled to a safety lead-in arm receiving cryoablation. The next 236 participants will be randomized in a 1:1 manner to either cryoablation or lumpectomy. Patients initially treated with cryoablation who have evidence of residual or recurrent tumor on follow-up imaging will be crossed over to receive a rescue lumpectomy.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety Lead-In: Number of treatment-related complications
timeFrame: Assessed from start of treatment through 30 days after cryoablation treatment (estimated to be 31 days)
measure: Randomized Controlled Trial: Ipsilateral breast cancer recurrence (IBTR) in the treated breast.
timeFrame: At 5 years.
Secondary outcomes:
measure: Proportion of patients who are free of serious treatment-related complications
timeFrame: Assessed from start of treatment through 30 days after cryoablation treatment (estimated to be 31 days)
measure: Proportion of patients who demonstrate disease-free survival (DFS)
timeFrame: Through 5 years.
measure: Overall survival (OS)
timeFrame: Through 5 years.
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Heather Garrett, M.D.
role: PRINCIPAL_INVESTIGATOR
References: