TAO-Towards Optimal (Neo)Adjuvant Systemic Therapy of Stage III Triple-negative 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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Breast Cancer. 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
- Нидерланды
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This prospective, national, multi-centre study will include patients with stage III triple-negative breast cancer (TNBC) who are planned to start with standard (neo)adjuvant systemic treatment. The study will gather clinico-pathological, treatment and follow-up information of participating patients through Dutch databases. Participating patients will be asked to complete cancer specific and more generic quality of life questionnaires at nine time points during and after their anticancer treatment in a mobile application. For all patients who have consented to additional blood collection, to assess the course of dynamic ctDNA during (neo)adjuvant chemotherapy and its relation with outcome, two tubes will be collected at four different time points.
Первичные конечные точки
- To determine the effects of the standard (neo)adjuvant systemic treatment on health-related quality of life (HRQoL) for patients with stage III TNBC. Questionnaire 1. [Срок оценки: Up to 36 months after surgery]
- To determine the effects of the standard (neo)adjuvant systemic treatment on health-related quality of life (HRQoL) for patients with stage III TNBC. Questionnaire 2. [Срок оценки: Up to 36 months after surgery]
- To determine the effects of the standard (neo)adjuvant systemic treatment on health-related quality of life (HRQoL) for patients with stage III TNBC. Questionnaire 3. [Срок оценки: Up to 36 months after surgery]
Вторичные конечные точки (12)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Срок оценки: Up to 24 months after start treatment]
- Cognitive functioning - Questionnaire [Срок оценки: Up to 36 months after surgery]
- Cognitive functioning - ASC (Amsterdam Cognition Scan) [Срок оценки: Up to 36 months after surgery]
- Oral health related quality of life (QoL) - EORTC-QLQ-OH15 [Срок оценки: Up to 36 months after surgery]
- Oral health related quality of life (QoL) - Xerostomia Inventory [Срок оценки: Up to 36 months after surgery]
- Oral health related quality of life (QoL) - Oral Impact on Daily Performance index [Срок оценки: Up to 36 months after surgery]
- Oral health related quality of life (QoL) - oral self-care questionnaire [Срок оценки: Up to 36 months after surgery]
- Resource use - Dutch hospital data (DHD) [Срок оценки: Up to 36 months after surgery]
- Costs - Dutch hospital data (DHD) [Срок оценки: Up to 36 months after surgery]
- Resource use - iMTA Medical Consumption Questionnaire (iMCQ) [Срок оценки: Up to 36 months after surgery]
- Resource use - iMTA Productivity Cost Questionnaire (iPCQ) [Срок оценки: Up to 36 months after surgery]
- Overall survival (OS) [Срок оценки: Up to 36 months after surgery]
Критерии участия
Критерии включения
- Patients aged 18 years or older
- Histologically confirmed adenocarcinoma of the breast
- Assumed clinical or pathological stage III (TNM) breast cancer
- Breast tumor must be:
- HER2-negative: i.e. either score 0 or 1 at immunohistochemistry or score 2 at immunohistochemistry and negative at in situ hybridization (ISH, CISH or FISH)
- Hormone receptor negative i.e. an estrogen receptor (ER) of <10% and progesterone receptor (PR) of <10%.; or in case of a histological grade III tumor an ER of <50% and a PR of <50%.
- Patients are planned to receive the complete standard of care in the Netherlands; neo-adjuvant chemotherapy according to local practise
- Participating patients have to be able to use a mobile phone, tablet, laptop and/or computer and understand the Dutch language
Критерии исключения
- Evidence of distant metastases. Staging examinations should have been performed according to Dutch national guidelines.
- Patients who are only treated systemically in the adjuvant setting
- Participation in another clinical study with an treatment intervention during the course of this study.
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 · 7 центров
- Medical spectrum Twente — Enschede
- Amsterdam University Medical Center — Amsterdam
- The Netherlands Cancer Institute — Amsterdam
- Amphia — Breda
- UMCG — Groningen
- Maastricht University Medical Center — Maastricht
- ErasmusMC — Rotterdam
Идентификаторы
NCT: NCT06931769 · M24TAO