Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07447414

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Breast Cancer Breast Cancer (Early Breast Cancer) Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Lucus Augusti

Lugo, 27003, Spain

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

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

Primary outcomes

  1. Cryoablation success rate

    Time frame: 30days after cryoablation

    Absence of tumor cells in a surgical specimen

Secondary outcomes

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

    Time frame: One day and one week after cryoablation

  2. Patient tolerance to cryoablation and surgery

    Time frame: 60 days after cryoablation

    Physicians Global Assessment to measure quality of life (0-10)

  3. 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%.

Study contacts

Contact information is provided by the study sponsor or research team.

Lucía Graña López, PhD

CONTACT

[email protected]

0034982296234

Sponsors and collaborators

Lead sponsor

Lucía Graña López

Other

Registry information

Official study title

Cryoablation for the Treatment of Luminal Early Breast Cancer

Acronym: LUBRECA

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 3, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.