Comparing cryoablation and lumpectomy for early-stage breast cancer
COOL-IT: Cryoablation vs Lumpectomy in T1 Breast Cancers: A Randomized Controlled Trial With Safety Lead-in
NA · Washington University School of Medicine · NCT05505643
This study is testing whether freezing tumors with cryoablation is a safe and effective alternative to the standard surgery called lumpectomy for women with early-stage breast cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 50 Years and up |
| Sex | Female |
| Sponsor | Washington University School of Medicine (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT05505643 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the safety and effectiveness of cryoablation, a technique that freezes tumors, in treating low-risk, early-stage breast cancer compared to the standard lumpectomy procedure. It focuses on patients diagnosed with invasive ductal carcinoma of the breast, specifically Luminal type A, and aims to assess disease control, complication rates, and quality of life outcomes. The study will initially review the safety of cryoablation before making direct comparisons with lumpectomy outcomes.
Who should consider this trial
Good fit: Ideal candidates are women aged 50 and older with early-stage, low-risk invasive ductal carcinoma that meets specific oncotype criteria.
Not a fit: Patients requiring neoadjuvant chemotherapy or those with a history of breast cancer are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a less invasive treatment option for patients with early-stage breast cancer, potentially improving their quality of life.
How similar studies have performed: While cryoablation is a novel approach in this context, similar studies have shown promise in other applications, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
St Louis, Missouri
- Washington University School of Medicine — St Louis, Missouri, United States (RECRUITING)
Study contacts
- Principal investigator: Heather Garrett, M.D. — Washington University School of Medicine
- Study coordinator: Heather Garrett, M.D.
- Email: hvgarrett@wustl.edu
- Phone: 636-916-9662
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Breast Neoplasm, breast cancer, cryoablation, lumpectomy