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Идёт набор NCT05440149

The Postoperative Radiotherapy in N1 Breast Cancer Patients

Фаза III С лечением Radiotherapy 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: No PMRT for mastectomy / No regional RT for BCS, PMRT for mastectomy / WBI + Regional RT for BCS.
Кому может быть актуально
Состояния в реестре: Radiotherapy, Breast Cancer. Базовые параметры: от 19 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
South Korea
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

The Postoperative Radiotherapy After Breast Conserving Surgery or Mastectomy in N1 Breast Cancer Patients: a Prospective, Multicenter, Phase III Clinical Trial

Обзор

This study is a multicenter, randomized, phase 3 clinical trial in patients with breast cancer, randomizing radiotherapy group (postmastectomy radiation therapy (PMRT)/whole breast irradiation plus regional radiotherapy (WBI+regional RT) versus and no PMRT/WBI alone group. This is a non-inferiority study aiming that there is no significant difference in the 7-year disease-free survival rate between the two groups.

Подробное описание

1:1 randomization to the control group and experimental group, stratified by the type of surgery (breast-conserving surgery (BCS) versus mastectomy) and the type of histologic type (triple negative breast cancer (TNBC) versus non-TNBC)

The control group:

* If patients received BCS, WBI+Regional RT * If patients received mastectomy, PMRT

The experimental group:

* If patients received breast conserving surgery, WBI alone * If patients received mastectomy, No PMRT

Вмешательства

  • Лучевая терапия No PMRT for mastectomy / No regional RT for BCS
    * Regional RT includes high-tangent field, and can include undissected axilla. * The definition of high-tangent is that the upper margin of the radiotherapy field located within 2 cm of the humeral head to include axillary levels I and II. * Both hypofractionated and conventionally fractionated radiation therapy are allowed, and 3-dimensional or intensity modulated radiotherapy are allowed. The electron beam can also be used.
  • Лучевая терапия PMRT for mastectomy / WBI + Regional RT for BCS
    * Regional RT includes high-tangent field, and can include undissected axilla. * The definition of high-tangent is that the upper margin of the radiotherapy field located within 2 cm of the humeral head to include axillary levels I and II. * Both hypofractionated and conventionally fractionated radiation therapy are allowed, and 3-dimensional or intensity modulated radiotherapy are allowed. The electron beam can also be used.

Первичные конечные точки

  • Disease-Free Survival [Срок оценки: 7-Year]
Вторичные конечные точки (3)
  • Locoregional-Recurrence Free Survival [Срок оценки: 7-Year]
  • Distant Metastases Free Survival [Срок оценки: 7-Year]
  • Overall Survival [Срок оценки: 7-Year]

Критерии участия

Критерии включения

  • Patients aged 19 years or older.
  • A female patient who underwent breast-conserving surgery or mastectomy for invasive breast cancer.
  • Patient with stage pN1 after surgery on histopathologic examination.
  • However, if mastectomy was performed, 5 or more nodes should be resected in the case of 1 positive node, and axillary lymph node dissection (ALND) should be performed in case of 2 or 3 positive nodes.
  • Patients undergoing or planning to undergo hormone therapy in the case of hormone receptor positive.
  • Patients who have received or are expected to undergo targeted therapy in the case of human epidermal growth factor receptor(HER)-2 positive.
  • Patients with Eastern Cooperative Oncology Group (ECOG) Scale 0-2.
  • Patients who agreed to participate in the study.

Критерии исключения

  • Patients who have received prior \[neoadjuvant\] chemotherapy.
  • Patients receiving radiation therapy for salvage or palliative purposes.
  • Patients with stage T4.
  • Patients with ipsilateral supraclavicular and internal mammary lymph node metastases or distant metastases.
  • Male breast cancer patient.
  • Patients who have previously received radiation therapy to the ipsilateral breast or supraclavicular region.
  • Patients having a history of cancer other than thyroid cancer, cervical carcinoma in situ, or skin cancer.
  • Patients diagnosed with ductal breast carcinoma in situ, lobular carcinoma in situ, phyllodes, metaplastic cancer, or benign tumors based on histological diagnosis.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

South Korea · 1 центр
  • Seoul National University Hospital — Seoul

Публикации

  • Lee TH, Chang JH, Jang BS, Kim JS, Kim TH, Park W, Kim YB, Kim SS, Han W, Lee HB, Shin KH. Protocol for the postoperative radiotherapy in N1 breast cancer patients (PORT-N1) trial, a prospective multicenter, randomized, controlled, non-inferiority trial of patients receiving breast-conserving surgery or mastectomy. BMC Cancer. 2022 Nov 16;22(1):1179. doi: 10.1186/s12885-022-10285-0. PMID 36384573

Идентификаторы

NCT: NCT05440149 · 0720222005

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗