Идёт набор NCT06839001

CRYoablation for Small Tumors As Local Treatment - SIX Trial

Фаза III С лечением Breast Cancer Breast Neoplasm

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: cryoablation, Breast Surgery (Lumpectomy or Mastectomy).
Кому может быть актуально: Состояния в реестре: Breast Cancer, Breast Neoplasm. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Бразилия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Cryoablation Versus Breast Surgery in the Local Treatment of Early-Stage Breast Cancer - Six Trial

Обзор

To demonstrate the non-inferiority of cryoablation compared to breast surgery for the local treatment of early-stage breast cancer and to conduct a cost-minimization analysis comparing direct costs between treatments.

Подробное описание

This study compares cryoablation with breast surgery for the treatment of early-stage breast cancer (T1N0M0), evaluating locoregional recurrence, cost-minimization, and disease-free survival.

The primary objective is to demonstrate the non-inferiority of cryoablation compared to breast surgery for local treatment of early-stage breast cancer over five years, as well as to perform a cost-minimization analysis to compare the direct costs of both treatments over one year.

The secondary objectives include assessing locoregional recurrence at one year, evaluating disease-free survival and overall survival over five years, analyzing circulating tumor cells (CTCs) as prognostic factors and for monitoring cryoablation at baseline (study inclusion), six months, and twelve months, measuring patient satisfaction one year after randomization using the Breast-Q questionnaire, and assessing quality of life using the EQ-5D questionnaire.

Cryoablation is a nonsurgical, minimally invasive technique that destroys tumor tissue through cyclic freezing and thawing using cryoprobes. This process induces cellular death without requiring hospitalization, allowing for faster recovery.

Additionally, the study incorporates a de-escalated and personalized approach to breast cancer treatment by omitting sentinel lymph node biopsy, integrating ultrahypofractionated radiotherapy, and utilizing liquid biopsy.

Вмешательства

Процедура cryoablation
Two devices can be used to perform cryoablation: Cryocare® and ProSense IceCure®: * Cryocare® - This procedure utilizes two types of gases: argon gas for freezing and helium gas for thawing. * ProSense IceCure® - This procedure uses extremely low temperatures generated by liquid nitrogen (LN2) to freeze and destroy the target tissue, without the need for an additional gas.
Процедура Breast Surgery (Lumpectomy or Mastectomy)
Surgery can be performed as lumpectomy or mastectomy and axillary surgery, preferably sentinel lymph node biopsy.

Первичные конечные точки

Locoregional recurrence (LRR) [Срок оценки: 5 years]
Cost-minimization [Срок оценки: 1 year]

Вторичные конечные точки (6)

Locoregional recurrence (LRR) [Срок оценки: 1 year]
Disease-free survival (DFS) [Срок оценки: 5 years]
Overall Survival (OS) [Срок оценки: 5 years]
Circulating tumor cells (CTCs) [Срок оценки: 1 year]
Patient satisfaction [Срок оценки: 1 month]
EQ-5D questionnaire [Срок оценки: 1 year]

Критерии участия

Критерии включения

Unifocal primary invasive breast carcinoma
Tumor size ≤ 2.0 cm (T1)
Complete pathological report (including results for ER, PR, HER2, Ki-67, and FISH report for the ERBB2 gene, if necessary)
Lesion visible on ultrasound
Surgical treatment would be the first option, regardless of immunohistochemistry results