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Набор скоро начнётся NCT07098507

De-escalation in Axillary Surgery for Early-stage Breast Cancer

Без фазы С лечением Omitting Sentinel Lymph Node Biopsy in Early-stage Breast Cancer

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: sentinel lymph node biopsy, omission of sentinel lymph node biopsy.
Кому может быть актуально
Состояния в реестре: Omitting Sentinel Lymph Node Biopsy in Early-stage Breast Cancer. Базовые параметры: от 55 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Хорватия
Следующий шаг
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Официальное название

Real-world Integration of De-Escalation in Axillary Surgery for Postmenopausal, Early Stage HR+HER2- Breast Cancer Patients

Обзор

The goal of this clinical trial is to determine if the omission of sentinel lymph node biopsy is safe for early-stage breast cancer patients in our institution (Clinical Hospital Centre Rijeka). Targeted group are postmenopausal patients, older than 55 years, diagnosed with hormone-receptor-positive breast cancer, with primary tumour less than 3 cm and unaffected axilla on clinical exam and axillary ultrasound. The main questions we aim to answer are: * if this treatment de-escalation affects patient oncological outcomes (cancer recurrence)? * if this treatment de-escalation affects patient clinical outcomes (early and late complications related to axillary surgery)? * if this omission of pathological examination of sentinel lymph node affects recommendations on postoperative treatments (irradiation and systemic therapy)? Researchers will compare outcomes between participants submitted to sentinel lymph node biopsy and participants in whom the procedure is omitted to answer those questions. Participants will be asked to: * decide in which group they wish to participate * visit the clinic for checkups and tests once every 6 months in first two years and yearly thereafter up to 5 years

Вмешательства

  • Процедура sentinel lymph node biopsy
    As sentinel lymph node biopsy is still a standard of care in early-stage breast cancer surgery, it represents the intervention in the standard of care arm
  • Процедура omission of sentinel lymph node biopsy
    omission of sentinel lymph node biopsy is the intervention in the experimental arm

Первичные конечные точки

  • Isolated regional recurrence free survival [Срок оценки: 5 years]
  • Disease free survival [Срок оценки: 5 years]
Вторичные конечные точки (6)
  • Isolated regional recurrence rate [Срок оценки: 5 years]
  • Any invasive recurrence rate [Срок оценки: 5 years]
  • Rate of adjuvant chemotherapy recommendation in standard and experimental arm [Срок оценки: 5 years]
  • Rate of adjuvant regional nodal irradiation in standard and experimental arm [Срок оценки: 4 years]
  • Rate of early postoperative complications in axilla in standard arm [Срок оценки: 3 years (accrual period)]
  • Rate of late complications of axillary surgery in standard arm [Срок оценки: 5 years]

Критерии участия

Критерии включения

  • newly diagnosed hormone receptor positive, HER2 negative invasive breast cancer or DCIS with microinvasion, histologically confirmed, in postmenopausal patients older than 55 years, with primary tumour up to 3 cm and uninvolved axillary lymph nodes on clinical examination and on axillary ultrasound performed in Clinical Hospital Centre Rijeka. Patients should be eligible for breast conserving surgery and adjuvant whole breast irradiation.

Критерии исключения

  • Patients younger than 55 years of age and/or premenopausal, with cN1-3 status (confirmed cytologically or histologically), or with multiple suspicious lymph nodes on axillary ultrasound, regardless of cytological/histological confirmation.
  • Patients diagnosed with pure breast carcinoma in situ (DCIS) without focal invasion
  • Patients with tumour larger than 3 cm or with cT4 status, with de novo metastatic disease
  • Patients with a breast cancer of HER2+ or triple-negative immunophenotype
  • Patients who have received any type of neoadjuvant systemic therapy before surgery and those who have a previous personal history of invasive breast cancer
  • Patients with extensive multifocal or multicentric breast cancer, patients scheduled for mastectomy, partial breast irradiation or who refuse recommended adjuvant systemic oncological treatment
  • Patients who do not wish to participate in a clinical trial

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Хорватия · 1 центр
  • Clinical Hospital Centre Rijeka — Rijeka

Идентификаторы

NCT: NCT07098507 · 2170-29-02/15-25-2

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗