Luminal Breast Cancer Cryoablation

Официальное название

Cryoablation for the Treatment of Luminal Early Breast Cancer

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство 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

Первичные конечные точки

• Cryoablation success rate [Срок оценки: 30days after cryoablation]

Вторичные конечные точки (3)

• Proportion of patients who are free of cryoablation related complications per CTCAE v 5.0 [Срок оценки: One day and one week after cryoablation]
• Patient tolerance to cryoablation and surgery [Срок оценки: 60 days after cryoablation]
• Analyze the impact of broadening the inclusion criteria comparing to previous trials [Срок оценки: 36 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hospital Universitario Lucus Augusti — Lugo

Публикации

• 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

Идентификаторы

NCT: NCT07447414 · 2025/476

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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