Идёт набор NCT06966141
A Real World Study of Sacituzumab Govitecan
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 Metastatic, Treatment Outcome. 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
- Китай
- 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 →
Официальное название
A Real World Study: Clinical Outcomes and Safety of Sacituzumab Govitecan in Metastatic HER-2 Negative Breast Cancer Patients
Обзор
Clinical Outcomes and Safety of Sacituzumab Govitecan in Metastatic HER-2 negative Breast Cancer Patients
Первичные конечные точки
- PFS [Срок оценки: Six months after the last patient was enrolled]
- ORR [Срок оценки: Up to approximately 12 weeks]
Критерии участия
Критерии включения
- Male or female aged 18 or above;
- The Eastern Cooperative Oncology Group (ECOG) physical condition score of the United States is ≤2;
- Unresectable or metastatic triple-negative breast cancer confirmed by tumor histology or cytology, and having received at least two systemic treatments previously (at least one of which was for metastatic disease); Or HR+/HER2- (IHC 0, 1+ or IHC 2+/ISH-) unresectable or metastatic breast cancer confirmed by tumor histology or cytology, with previous endocrine therapy and ≥2 lines of systemic therapy (for metastatic disease);
- Receive gosatetuzumab treatment in the advanced stage;
- During the study period, voluntarily abide by this trial protocol and receive regular follow-ups;
- All women of childbearing age, fertile men or their spouses who have no plans for fertility or sperm donation throughout the trial period until 6 months after the last dose, or who voluntarily take effective contraceptive measures.
Критерии исключения
- Pregnant or lactating women;
- Those with acute or chronic infections, or those with other serious diseases at the same time, are judged by the researchers as unsuitable for this study;
- Having suffered from other malignant tumors within 5 years (excluding the following situations: cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid carcinoma; A second primary cancer that has been completely cured and has no recurrence within five years; Researchers have clearly identified which primary tumor source the metastatic foci belong to.
- Those with mental illness or mental disorders, poor compliance and inability to cooperate and describe treatment responses;
- Those with severe organic diseases or major organ failure, such as decompensated heart, lung, liver or kidney failure, which makes them unable to tolerate treatment;
- Patients allergic to gosatetuzumab;
- Patients who changed their treatment regimens after gosatetuzumab treatment due to non-disease progression reasons;
- The researcher believes that the patient has other circumstances that make them unsuitable for participating in this study.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Другое
Центры проведения
Китай · 1 центр
- Fudan University Shanghai Cancer Center — Шанхай
Идентификаторы
NCT: NCT06966141 · WONDER