Liquid-nitrogen cryoablation for small luminal breast tumors
Official title: Cryoablation for the Treatment of Luminal Early Breast Cancer
Run by Hospital Universitario Lucus Augusti · NCT07447414 · Data updated 2026-11-12
This trial will try liquid-nitrogen cryoablation to destroy small (≤2 cm) luminal breast cancers in postmenopausal women before surgical removal.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | Women only |
| Enrollment | 140 (estimated) |
| Sponsor | Hospital Universitario Lucus Augusti Academic / other |
| Locations | 1 site (Lugo, Lugo) |
| Status | Recruiting |
| Started | April 8, 2026 |
| Main results expected | September 2028 |
| Study ends | December 2028 |
| Registry record updated | April 16, 2026 |
| Trial ID | NCT07447414 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Postmenopausal women with a single ER/PR-positive, HER2-negative invasive breast tumor ≤2 cm by imaging, no suspicious axillary nodes, and who are candidates for surgery.
✕Probably not a fit
Patients with invasive lobular carcinoma, extensive in situ component, multifocal or multicentric disease, axillary or distant metastases, contraindications to contrast mammography, or who are not surgical candidates are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective study will enroll 140 postmenopausal women with a single invasive luminal (ER/PR-positive, HER2-negative) breast tumor up to 2 cm and no suspicious axillary nodes on ultrasound. Participants will receive percutaneous cryoablation using liquid nitrogen delivered with the Prosense® system. After ablation, patients will undergo radio-guided surgical resection and axillary evaluation, and the surgical specimen will be examined for any remaining viable tumor cells. Cryoablation and surgery side effects, tolerance, and follow-up treatments will be recorded according to usual clinical practice.
Why it matters
Potential benefit: If successful, cryoablation could destroy tumors with a minimally invasive procedure and might reduce the extent of surgery or support future non-surgical options.
How similar studies have gone: Smaller single-center studies of breast cryoablation have shown promising tumor destruction and low complication rates, but larger prospective trials are limited and the approach is not yet standard care.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Postmenopausal women diagnosed with invasive breast cancer by core needle biopsy or vacuum-assisted biopsy * Unifocal * Lesion ≤ 2 cm (on ultrasound and contrast enhanced mammography) * No axillary lymphadenopathy on ultrasound * No axillary lymph node involvement on ultrasound. * Luminal tumor (estrogen and/or progesterone receptor positive) * HER2 negative * Signed informed consent Exclusion Criteria: * Infiltrating lobular carcinoma * Extensive in situ component * Multifocality or multicentricity * Contraindication for contrast mammography * Not candidate for surgery * Distant metastasis -
Where it's running
-
Hospital Universitario Lucus Augusti
Lugo, Lugo, Spain Recruiting
Study contacts
- Principal investigator: Lucía Graña López, PhD — Hospital Universitario Lucus Augusti
- Study coordinator: Lucía Graña López, PhD
- Email: grana.lopez.lucia@gmail.com
- Phone: 0034982296234
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.