NCT07447414

Luminal Breast Cancer Cryoablation

Cryoablation for the Treatment of Luminal Early Breast Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Lucía Graña López · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

LUBRECA will evaluate the safety and efficacy of cryoablation with liquid nitrogen to treat cT1cN0 luminal breast cancer diagnosed in postmenopausal women

Detailed description

This is a prospective transversal study that will include 140 postmenopausal women with unifocal invasive breast cancer diagnosed with core or vacuum-assisted biopsy, up to 2 cm measured in ultrasound and contrast enhanced mammography, without metastatic lymph nodes in axillary ultrasound, hormone receptor positive and human epidermal factor receptor 2 (HER) negative. Patients with invasive lobular carcinoma, extensive intraductal component, not suitable for surgery or with metastatic disease will be excluded. Participants will receive cryoablation treatment of the tumor and, after, they will undergo radio-guided surgical resection. The presence of residual viable tumoral cells will be evaluated in the surgical specimen. Axillary evaluation during surgery and adjuvant treatment will be planned accordant to the usual clinical practice. Cryoablation and surgery side effects and tolerance will be evaluated.

Conditions

• Breast Cancer
• Breast Cancer (Early Breast Cancer)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-04-08
• Primary completion: 2028-09-01
• Completion: 2028-12-01
• First posted: 2026-03-03
• Last updated: 2026-04-16

Locations

1 site across 1 country: Spain