Recruiting
Luminal Breast Cancer Cryoablation
LUBRECA will evaluate the safety and efficacy of cryoablation with liquid nitrogen to treat cT1cN0 luminal breast cancer diagnosed in postmenopausal women
ClinicalTrials.gov IDNCT07447414
PhaseNA
Enrollment140
SponsorLucía Graña López
AgeNo minimum reported
SexFEMALE
Conditions studied
Breast Cancer, Breast Cancer (Early Breast Cancer)
About this study
LUBRECA will evaluate the safety and efficacy of cryoablation with liquid nitrogen to treat cT1cN0 luminal breast cancer diagnosed in postmenopausal women
Interventions
- Device: Cryoablation with liquid nitrogen (Prosense® system) — The appropriate cryoprobe (10G or 13G) will be selected depending on the size of the tumor. After injecting local anesthesia, the cryoprobe will be inserted along the longest diameter of the lesion. The tip of the needle will be advanced so that the freezing center is located in the middle of the tumor. Two freezing cycles will be performed, separated by a thawing cycle, all three of the same duration, which depends on the size of the tumor. The goal is a freezing volume with a lethal zone covering the lesion and a safety margin of at least 1 cm. Ultrasound allows real-time monitoring of the expansion of the ice ball during cryoablation. To avoid burning the skin, we will inject warm sterile saline solution when the distance between the ice and the skin surface is less than 0.5 cm
Primary outcomes
- Cryoablation success rate (30days after cryoablation)
Eligibility information
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 -
Study locations
- Hospital Universitario Lucus Augusti, Lugo, Lugo 27003 Spain
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-29.