Clinical trial · Interventional
Luminal Breast Cancer Cryoablation
Cryoablation for the Treatment of Luminal Early Breast Cancer
NCT07447414CI-TRIAL-00108445LUBRECArecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
LUBRECA will evaluate the safety and efficacy of cryoablation with liquid nitrogen to treat cT1cN0 luminal breast cancer diagnosed in postmenopausal women
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer (Early Breast Cancer) | Malignant Breast Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryoablation with liquid nitrogen (Prosense® system) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Breast cancer
- description
- Early stage luminal breast cancers up to 2 cm
- interventionNames
- Device: Cryoablation with liquid nitrogen (Prosense® system)
Primary outcomes (1)
- measure
- Cryoablation success rate
- timeFrame
- 30days after cryoablation
- description
- Absence of tumor cells in a surgical specimen
Secondary outcomes (3)
- measure
- Proportion of patients who are free of cryoablation related complications per CTCAE v 5.0
- timeFrame
- One day and one week after cryoablation
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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 -
References
Publications (1)
- BACKGROUNDFine RE, Gilmore RC, Tomkovich KR, Dietz JR, Berry MP, Hernandez LE, Columbus KS, Seedman SA, Fisher CS, Han LK, Manahan ER, Hicks RD, Vaidya RP, Curcio LD, Sevrukov AB, Kenler AS, Taback B, Chen M, Miller ME, Gold L, Anglin BV, Aoun HD, Simmons RM, Feldman SM, Boolbol SK. Cryoablation Without Excision for Early-Stage Breast Cancer: ICE3 Trial 5-Year Follow-Up on Ipsilateral Breast Tumor Recurrence. Ann Surg Oncol. 2024 Oct;31(11):7273-7283. doi: 10.1245/s10434-024-16181-0. Epub 2024 Sep 16. PMID 39283572