NCT07447414

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
28mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Apr 2026Dec 2028

First Submitted

Initial submission to the registry

February 23, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 8, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

2.4 years

First QC Date

February 23, 2026

Last Update Submit

April 15, 2026

Conditions

Breast CancerBreast Cancer (Early Breast Cancer)

Keywords

CryoablationLiquid nitrogenCryosurgeryPercutaneous treatment

Outcome Measures

Primary Outcomes (1)

  • Cryoablation success rate

    Absence of tumor cells in a surgical specimen

    30days after cryoablation

Secondary Outcomes (3)

  • Proportion of patients who are free of cryoablation related complications per CTCAE v 5.0

    One day and one week after cryoablation

  • Patient tolerance to cryoablation and surgery

    60 days after cryoablation

  • Analyze the impact of broadening the inclusion criteria comparing to previous trials

    36 months

Study Arms (1)

Breast cancer

OTHER

Early stage luminal breast cancers up to 2 cm

Device: Cryoablation with liquid nitrogen (Prosense® system)

Interventions

Cryoablation with liquid nitrogen (Prosense® system)DEVICE

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

Breast cancer

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Infiltrating lobular carcinoma
  • Extensive in situ component
  • Multifocality or multicentricity
  • Contraindication for contrast mammography
  • Not candidate for surgery
  • Distant metastasis -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Lucus Augusti

Lugo, Lugo, 27003, Spain

RECRUITING

Related Publications (1)

  • Fine 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: 39283572BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ablation TechniquesSurgical Procedures, Operative

Study Officials

  • Lucía Graña López, PhD

    Hospital Universitario Lucus Augusti

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucía Graña López, PhD

CONTACT

0034982296234grana.lopez.lucia@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief of the Breas Unit

Study Record Dates

First Submitted

February 23, 2026

First Posted

March 3, 2026

Study Start

April 8, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)