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Идёт набор NCT04486495

Minimal Invasive Axillary Staging and Treatment After Neoadjuvant Systemic Therapy in Node Positive Breast Cancer

— Наблюдательное Breast Cancer Neoadjuvant Therapy Lymph Node Metastases

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Breast Cancer, Neoadjuvant Therapy, Lymph Node Metastases. Базовые параметры: от 18 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
Нидерланды
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

Minimal Invasive Axillary Staging and Treatment After Neoadjuvant Systemic Therapy in Node Positive Breast Cancer (MINIMAX): a Dutch Multicenter Observational Study to Gain Insight in Less and More Invasive Axillary Staging and Treatment in Relation to Oncologic Safety and Quality of Life to Develop Evidence-based Guidelines.

Обзор

Today, the majority of clinically node positive (cN+) breast cancer patients is treated with neoadjuvant systemic therapy (NST). Axillary staging and treatment after NST in cN+ patients are areas of controversy. Patients with a pathological complete response (pCR) of the axillary lymph nodes are not expected to benefit from axillary lymph node dissection (ALND). Hence, less invasive axillary staging procedures are being introduced to avoid unnecessary ALND. However, evidence supporting the safety of replacing ALND by less invasive techniques in terms of oncologic safety and impact on quality of life (QoL) is lacking.

Подробное описание

The MINIMAX is a multicenter registry study that includes node positive breast cancer patients, who are treated with NST (chemotherapy and ± immunotherapy), in order to gain insight in the oncologic safety and impact on QoL of less and more invasive axillary staging and treatment strategies.

Patients who are included in this study will complete Patient Reported Outcome Measures (PROMs) at baseline (time of diagnosis), and 1 and 5 years after diagnosis to assess impact on QoL.

A database will be built by the Netherlands Cancer Registry. Data on patient-, tumor-, pre-NST staging-, post-NST staging- and treatment-characteristics will be retrieved from patients' records by trained data registrars of the Netherlands Comprehensive Cancer Organisation (IKNL) using electronic case report forms (eCRFs). Five-year survival and recurrence will be evaluated to determine oncologic safety.

The results will be incorporated in the national guidelines. In case of an equilibrium between less and more invasive strategies, the data of this study will at least be extremely suitable to be used in the shared decision making process.

Первичные конечные точки

  • Disease free survival (DFS) [Срок оценки: 5 years]
  • Breast cancer specific survival (BCSS) [Срок оценки: 5 years]
  • Overall survival (OS) [Срок оценки: 5 years]
  • Axillary recurrence rate (ARR) [Срок оценки: 5 years]
  • Quality of life, as measured by EQ-5D-5L [Срок оценки: Baseline, and 1 and 5 years after baseline]
  • Quality of life, as measured by Quality of Life Questionnaire Core 30 Items (QLQ-C30) and QLQ-BR23 [Срок оценки: Baseline, and 1 and 5 years after baseline]
  • Quality of life, as measured by BREAST-Q, which includes the following domains: satisfaction with breasts, psychosocial well being, physical well being, sexual well being. [Срок оценки: Baseline, and 1 and 5 years after baseline]

Критерии участия

Критерии включения

  • Female patient with unilateral invasive breast cancer and cN1-3
  • Pathologically proven positive axillary lymph node
  • Planned to undergo neoadjuvant chemotherapy (± immunotherapy), followed by staging and treatment of the breast and axilla

Критерии исключения

  • Clinically node negative breast cancer before NST
  • Bilateral invasive breast cancer
  • Neoadjuvant endocrine therapy
  • Distant metastases (including oligometastatic disease)
  • History of invasive breast cancer
  • Other malignancies, except for basal/squamous cell skin cancer, and in situ carcinoma of the cervix or breast
  • Axillary surgery or radiotherapy before NST (this includes SLNB prior to NST)

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Нидерланды · 35 центров
  • Jeroen Bosch Hospital — 's-Hertogenbosch
  • Northwest Clinics — Alkmaar
  • The Netherlands Cancer Institute — Amsterdam
  • Gelre Hospital — Apeldoorn
  • Rijnstate Hospital — Arnhem
  • Red Cross Hospital — Beverwijk
  • Alexander Monro Hospital — Bilthoven
  • Amphia Hospital — Breda
  • … и ещё 27 центров

Идентификаторы

NCT: NCT04486495 · 2020-12518

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗