RECRUITING

Cryoablation vs Lumpectomy in T1 Breast Cancers

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04-03
Study Completion:2031-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05505643

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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).
  2. * 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.
  3. * At least 50 years of age.
  4. * Mass must be visible on ultrasound and \>5 mm from skin and chest wall muscles.
  5. * Able to understand and willing to sign an IRB-approved written informed consent document.
  1. * Indication for neoadjuvant chemotherapy.
  2. * Presence of BRCA 1 and/or BRCA 2 mutation.
  3. * Prior history of breast cancer.
  4. * Breast augmentation.
  5. * Allergy to local anesthetics.
  6. * Pregnant or lactating. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
  7. * DCIS present beyond the proposed ablation zone on MRI, mammography, or ultrasound.
  8. * Positive axillary lymph nodes as assessed by axillary ultrasound, axillary sampling, or axillary sentinel node procedure.

Contacts and Locations

Study Contact

Heather Garrett, M.D.
CONTACT
636-916-9662
hvgarrett@wustl.edu

Principal Investigator

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

Study Locations (Sites)

Washington University School of Medicine
Saint Louis, Missouri, 63110
United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-03
Study Completion Date2031-10-31

Study Record Updates

Study Start Date2024-04-03
Study Completion Date2031-10-31

Terms related to this study

Keywords Provided by Researchers

  • breast cancer
  • cryoablation
  • lumpectomy

Additional Relevant MeSH Terms

  • Breast Cancer
  • Breast Neoplasm