A Prospective, Multicenter Registry to Observe the Treatment Patterns, Clinical Outcomes, and Decision-Making in Patients With Early Breast Cancer Eligible for EndoPredict® Testing
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, Breast Adenocarcinoma. 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
- Греция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Обзор
The study is planned to observe and document the therapeutic decision-making process, treatment protocols, and clinical outcomes in patients with luminal breast cancer, whether they have undergone EndoPredict® testing or not
Подробное описание
PRELUDE is a prospective, multicenter, non-interventional registry designed to describe real-world treatment decision-making, treatment patterns, and long-term clinical outcomes in patients with luminal (ER-positive/HER2-negative) early breast cancer who are eligible for EndoPredict® testing, including patients who do and do not undergo the test.
The registry will be conducted at approximately 10-20 sites across Greece (with the option to add sites outside Greece if needed) and aims to enroll up to 2,000 eligible participants within 3 years. Participants may be enrolled after surgical histopathology results are available and before commencement of adjuvant endocrine treatment, and will be followed prospectively once per year for up to 10 years after surgery.
The study aims to assess 5- and 10-year clinical outcomes and to evaluate these outcomes according to EndoPredict® (EP/EPclin) risk groups or scores among patients who undergo testing, in a real-world setting. The registry will also examine which patient and disease characteristics (e.g., age, menopausal status, nodal status, histopathology, EPclin score) will influence adjuvant treatment decisions, in the context of evolving therapeutic standards and recently introduced adjuvant options.
Первичные конечные точки
- Distant relapse free survival (DRFS) [Срок оценки: 5- and 10-years]
- Overall Survival (OS) [Срок оценки: 5- and 10-years]
- Distant relapse free interval (DRFI) [Срок оценки: 5- and 10-years]
- Proportion of adjuvant chemotherapy administration and association with baseline clinicopathologic characteristics and EPclin score [Срок оценки: Up to 2 months post-operatively]
Вторичные конечные точки (7)
- Local relapse free survival (LRFS) [Срок оценки: 5- and 10-years]
- Performance of EndoPredict (assessed with DRFS) in specific population subgroups [multifocal-multicentric disease (MFMC), node-positive, pre-menopausal women] [Срок оценки: 5- and 10-years]
- Performance of EndoPredict (assessed with DRFI) in specific population subgroups [multifocal-multicentric disease (MFMC), node-positive, pre-menopausal women] [Срок оценки: 5- and 10-years]
- OS in specific sub-groups (MFMC, node-positive, pre-menopausal women) [Срок оценки: 5- and 10-years]
- DRFS in specific sub-groups (MFMC, node-positive, pre-menopausal women) [Срок оценки: 5- and 10-years]
- DRFI in specific sub-groups (MFMC, node-positive, pre-menopausal women) [Срок оценки: 5- and 10-years]
- LRFS in specific sub-groups (MFMC, node-positive, pre-menopausal women) [Срок оценки: 5- and 10-years]
Критерии участия
Критерии включения
- Age ≥ 18 years old.
- Histological diagnosis of invasive breast cancer.
- T1-T3 tumor size.
- 0-3 positive axillary lymph nodes.
- Documented ER-positive tumor by immunohistochemistry (≥1% or Allred Score: ≥3/8 or H-score: ≥50/ 300)
- Documented HER2-negative tumor by immunohistochemistry and/or in situ hybridization
- Subject with signed and dated informed consent form.
Критерии исключения
- History of another primary malignancy within the last 5 years, except for resected non-melanoma skin cancer.
- Pre-operative chemotherapy administered.
- Subject without signed and dated informed consent form.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Греция · 13 центров
- "Elena Venizelou" General Hospital, Department of Surgery — Athens
- "Prolipsis" Center, Breast Unit — Athens
- Henry Dunant Hospital Center, 3rd Breast Surgical Department — Athens
- Laiko Hospital, National and Kapodistrian University of Athens, Medical School — Athens
- Mediterraneo Hospital, Breast Clinic — Athens
- Metropolitan General Hospital, 3rd Breast Clinic — Cholargós
- Metropolitan General Hospital, 4th Breast Clinic — Cholargós
- "Apollonio-Theotokos" General Clinic, Department of Surgery — Larissa
- … и ещё 5 центров
Идентификаторы
NCT: NCT07389408 · 84/18.03.2025