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Идёт набор NCT05851014

A Study of GB491 in Combination With Letrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer

Фаза III С лечением 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
В протоколе указаны: GB491 combined with Letrozole, Placebo combined with Letrozole.
Кому может быть актуально
Состояния в реестре: Breast Cancer. Базовые параметры: 18 лет — 75 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 →

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Официальное название

A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of GB491 in Combination With Letrozole in Subjects With HR Positive and HER2 Negative Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Received Systemic Therapy in This Disease Setting

Обзор

The main purpose of this study is to evaluate the efficacy and safety of GB491 combined with Letrozole versus placebo combined with Letrozole in the treatment of HR+/HER2- locally advanced or metastatic breast cancer without prior systemic antitumor therapy

Вмешательства

  • Препарат GB491 combined with Letrozole
    Patients were randomized to receive GB491 150 mg orally twice daily, depending on their assignment. Letrozole 2.5 mg orally once a day from the first day of cycle 1 (one cycle every 28 days)
  • Препарат Placebo combined with Letrozole
    Patients were randomized to receive placebo orally twice daily, depending on their assignment. Letrozole 2.5 mg orally once a day from the first day of cycle 1 (one cycle every 28 days)

Первичные конечные точки

  • Investigator-assessed PFS based on RECIST v1.1 [Срок оценки: Approximately 60 months]
Вторичные конечные точки (7)
  • BICR-assessed PFS based on RECIST v1.1. [Срок оценки: Approximately 60 months]
  • OS [Срок оценки: Approximately 60 months]
  • ORR [Срок оценки: Approximately 60 months]
  • DOR [Срок оценки: Approximately 60 months]
  • DCR [Срок оценки: Approximately 60 months]
  • CBR [Срок оценки: Approximately 60 months]
  • Number of Participants With adverse events (AEs) and serious adverse events (SAEs) Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0 [Срок оценки: Approximately 60 months]

Критерии участия

Критерии включения

  • 1\. Age: 18-75 years old;
  • Have a pathologically-confirmed diagnosis of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer;
  • No previous systematic antitumor therapy for locally advanced or metastatic breast cancer;
  • Eastern Cooperative Oncology Group \[ECOG\] 0-1;
  • Have adequate organ and marrow function;
  • Agree to sign the informed consent;

Критерии исключения

  • Systematic treatment with any other CDK4/6 inhibitor；
  • Subjects with known allergy to GB491 or any component of Letrozole；
  • Confirmed diagnosis of HER2 positive disease;
  • Known uncontrolled, or symptomatic central nervous system metastases;
  • Had major surgery (or is expected to require major surgery during the study period), chemotherapy, radiation, any investigational drug, or other antitumor therapy within 4 weeks prior to randomization;
  • Have previously received chemotherapy for locoregionally recurrent or metastatic breast cancer;
  • Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure, or ventricular arrhythmia which need medical intervention；
  • Known history of HIV infection or HIV seropositivity (including HIV antibody positive at the time of screening)

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
Четверное слепое
Основная цель
Лечение

Центры проведения

Китай · 52 центра
  • The First Affiliated Hospital of Bengbu Medical College — Bengbu
  • The First Hospital of Anhui Medical University — Хэфэй
  • Anhui Cancer Hospital — Хэфэй
  • The Second Hosptial of Anhui Medical University — Хэфэй
  • Betjing Tiantan Hosptial，Capital Medical University — Пекин
  • Chinese PLA General Hospial — Пекин
  • The First Affiliated Hospital of Chongqing Medical University — Чунцин
  • Chongqing University Cancer Hospital — Чунцин
  • … и ещё 44 центра

Идентификаторы

NCT: NCT05851014 · GB491-008

Первоисточники (государственные реестры)

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