Liquid-nitrogen cryoablation for small luminal breast tumors
Cryoablation for the Treatment of Luminal Early Breast Cancer
This trial will try liquid-nitrogen cryoablation to destroy small (≤2 cm) luminal breast cancers in postmenopausal women before surgical removal.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Sex | Female |
| Sponsor | Hospital Universitario Lucus Augusti Academic / other |
| Locations | 1 site (Lugo, Lugo) |
| Trial ID | NCT07447414 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Lugo, Lugo
- 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
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.