Luminal Breast Cancer Cryoablation (LUBRECA)

April 15, 2026 updated by: Lucía Graña López

Cryoablation for the Treatment of Luminal Early Breast Cancer

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Lugo
      • Lugo, Lugo, Spain, 27003
        • Recruiting
        • Hospital Universitario Lucus Augusti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Breast cancer
Early stage luminal breast cancers up to 2 cm
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cryoablation success rate
Time Frame: 30days after cryoablation
Absence of tumor cells in a surgical specimen
30days after cryoablation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who are free of cryoablation related complications per CTCAE v 5.0
Time Frame: One day and one week after cryoablation
One day and one week after cryoablation
Patient tolerance to cryoablation and surgery
Time Frame: 60 days after cryoablation
Physicians Global Assessment to measure quality of life (0-10)
60 days after cryoablation
Analyze the impact of broadening the inclusion criteria comparing to previous trials
Time Frame: 36 months
Subgroup analysis: comparing the efficacy of cryoablation in tumors: ≤ 1.5 cm / 1.5-2 cm; grade I-II / grade III; invasive ductal/ others (mucinous, cribriform, tubular, papillary, micropapillary...); proliferation index (ki67) ≤ 20% / 21-50% / > 50%.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lucía Graña López

Investigators

  • Principal Investigator: Lucía Graña López, PhD, Hospital Universitario Lucus Augusti

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

February 23, 2026

First Submitted That Met QC Criteria

February 26, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/476

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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