Идёт набор NCT07492641
BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease
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: BGB-43395, Letrozole, Abemaciclib, Palbociclib.
- Кому может быть актуально
- Состояния в реестре: HR+/HER2- 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
- США, Австралия, Китай, Япония, Малайзия +3
- 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
An Open-Label, Randomized, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole Versus CDK4/6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease
Обзор
The purpose of this study is to investigate the efficacy and safety of BGB-43395 in combination with letrozole compared with investigator's choice of cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) in combination with letrozole in patients with advanced or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC) who have not received prior systemic treatment for advanced or metastatic disease.
Вмешательства
- Препарат BGB-43395
Administered orally. - Препарат Letrozole
Administered orally. - Препарат Abemaciclib
Administered orally. - Препарат Palbociclib
Administered orally. - Препарат Ribociclib
Administered orally.
Первичные конечные точки
- Progression-Free Survival (PFS) Determined by Blinded Independent Central Review (BICR) [Срок оценки: Up to approximately 4 years]
Вторичные конечные точки (9)
- Overall Survival (OS) [Срок оценки: Up to approximately 11 years]
- Overall Response Rate (ORR) [Срок оценки: Up to approximately 4 years]
- Duration of Response (DOR) [Срок оценки: Up to approximately 4 years]
- PFS Determined by Investigator [Срок оценки: Up to approximately 4 years]
- Clinical Benefit Rate (CBR) [Срок оценки: Up to approximately 4 years]
- Time to Response (TTR) [Срок оценки: Up to approximately 4 years]
- Number of Participants with Adverse Events (AEs) [Срок оценки: From first dose of study drug up to 30 days after last dose, up to approximately 11 years]
- Change from Baseline in European Organisation for Research and Treatment of Cancer (EORTC)-Item Library (IL)454. [Срок оценки: Baseline and up to approximately 4 years]
- Progression-Free Survival 2 (PFS2) [Срок оценки: Up to approximately 4 years]
Критерии участия
Критерии включения
- Participants must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the informed consent.
- Participants with histologically confirmed locally advanced or metastatic HR+ HER2- breast cancer.
- Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.
- Adequate organ function.
Критерии исключения
- Participants who have received prior systemic treatment in the advanced or metastatic setting.
- Participants who have received prior treatment with any selective cyclin-dependent kinase 4 (CDK4) or cyclin-dependent kinase 2 (CDK2) targeting agent, or any other investigational anticancer drug in any disease setting, except for prior investigational or approved SERDs in the adjuvant setting, provided that disease recurrence occurred more than 12 months after the last dose of endocrine-based therapy.
- Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis.
Note: Other protocol-defined inclusion/exclusion criteria may apply.
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
США · 33 центра
- Alabama Oncology Princeton — Birmingham
- Alaska Oncology and Hematology, Llc — Anchorage
- Ironwood Cancer and Research Centers Chandler Ii — Chandler
- Genesis Cancer and Blood Institute Hot Springs (Harmony Park) — Hot Springs
- Helios Clinical Research the Oncology Institute Fountain Valley — Fountain Valley
- Brcr Coral Springs — Coral Springs
- Florida Clinical Trials Group Plantation — Plantation
- Hematology Oncology Associates of the Treasure Coast — Port Saint Lucie
- … и ещё 25 центров
South Korea · 25 центров
- Inje University Haeundae Paik Hospital — HaeundaeGu
- Dong A University Hospital — Seogu
- Chungbuk National University Hospital — Cheongju-si
- Soon Chun Hyang University Cheonan Hospital — Cheonansi
- Keimyung University Dongsan Hospital — Dalseogu
- Cha Bundang Medical Center, Cha University — BundangGu SeongnamSi
- Korea University Ansan Hospital — DanwonGu AnsanSi
- National Cancer Center (Korea) — IlsandongGu GoyangSi
- … и ещё 17 центров
Япония · 11 центров
- Japan Community Healthcare Organization Kurume General Hospital — Kurumeshi
- National Hospital Organization Hokkaido Cancer Center — Sapporo
- Hyogo Medical University Hospital — Nishinomiyashi
- Social Medical Corporation Hakuaikai Sagara Hospital — Kagoshima
- Tokai University Hospital — Iseharashi
- Nippon Medical School Musashi Kosugi Hospital — Kawasakishi
- Yokohama City University Medical Center — Yokohama
- Mie University Hospital — Tsu
- … и ещё 3 центра
Австралия · 7 центров
- Blacktown Cancer and Haematology Centre — Blacktown
- Wollongong Hospital — Wollongong
- Sunshine Coast University Private Hospital — Birtinya
- Townsville University Hospital — Douglas
- Peter Maccallum Cancer Centre — Melbourne
- Fiona Stanley Hospital — Murdoch
- One Clinical Research — Nedlands
Малайзия · 7 центров
- Pulau Pinang Hospital — George Town
- Hospital Wanita Dan Kanak Kanak Sabah (Hospital Likas) — Kota Kinabalu Sabah
- Hospital Kuala Lumpur — Kuala Lumpur
- University Malaya Medical Centre — Kuala Lumpur
- Sarawak General Hospital — Kuching
- Hospital Picaso — Petaling Jaya
- National Cancer Institute (Institut Kanser Negara) — Putrajaya
Китай · 5 центров
- The Peoples Hospital Affiliated to Fujian University of Traditional Chinese Medicine — Фучжоу
- Cancer Hospital of Shantou University Medical College — Shantou
- Guangxi Medical University Cancer Hospital Wuxiang Branch — Nanning
- Hainan General Hospital — Haikou
- Fudan University Shanghai Cancer Center — Шанхай
Пуэрто-Рико · 1 центр
- Brcr Global Puerto Rico Hato Rey — San Juan
Великобритания · 1 центр
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07492641 · BGB-43395-302 · 2025-523960-19-00