NCT05505643 Cryoablation vs Lumpectomy in T1 Breast Cancers
| NCT ID | NCT05505643 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Washington University School of Medicine |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-04-03 |
| Primary Completion | 2033-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2024-04-03 with a primary completion date of 2033-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 (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.
Contact & Investigator
Heather Garrett, M.D.
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT05505643 clinical trial?
This trial is open to female participants only, aged 50 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05505643 currently recruiting?
Yes, NCT05505643 is actively recruiting participants. Contact the research team at hvgarrett@wustl.edu for enrollment information.
Where is the NCT05505643 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT05505643 clinical trial?
NCT05505643 is sponsored by Washington University School of Medicine. The principal investigator is Heather Garrett, M.D. at Washington University School of Medicine. The trial plans to enroll 120 participants.
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