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Recruiting NCT07447414

Luminal Breast Cancer Cryoablation

No phase Interventional Breast Cancer Breast Cancer (Early Breast Cancer)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cryoablation with liquid nitrogen (Prosense® system).
Who it may be relevant to
Registry conditions: Breast Cancer, Breast Cancer (Early Breast Cancer). Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Cryoablation for the Treatment of Luminal Early Breast Cancer

Overview

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.

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 cover

Primary outcome measures

  • Cryoablation success rate [Time frame: 30days after cryoablation]
Secondary outcome measures (3)
  • Proportion of patients who are free of cryoablation related complications per CTCAE v 5.0 [Time frame: One day and one week after cryoablation]
  • Patient tolerance to cryoablation and surgery [Time frame: 60 days after cryoablation]
  • Analyze the impact of broadening the inclusion criteria comparing to previous trials [Time frame: 36 months]

Eligibility criteria

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 -

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Hospital Universitario Lucus Augusti — Lugo

Publications

  • 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 Recurrenc PMID 39283572

Identifiers

NCT: NCT07447414 · 2025/476

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗