Ribociclib for HR-positive HER2-negative Metastatic 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: Ribociclib 400mg, Ribociclib 600mg, Ribociclib 600mg.
- 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
- Япония
- 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
Phase Ib/II Trial of Ribociclib Plus Anastrozole in Patients With Hormone Receptor-Positive, HER2-Negative Metastatic or Recurrent Breast Cancer
Обзор
This document outlines an investigator-initiated Phase Ib/II clinical trial in Japan, focusing on the combination therapy of ribociclib and anastrozole for patients with hormone receptor-positive (HR-positive), HER2-negative metastatic or recurrent breast cancer. The trial aims to evaluate the efficacy (specifically, overall response rate) and safety of this combination in the Japanese patient population. Nagoya City University is the sponsor of this trial, with funding provided by Novartis Pharma K.K.. Study Design and Endpoints: The trial is structured into two parts: * Phase Ib: The primary endpoint for this phase is tolerability, which is assessed by dose-limiting toxicities (DLT). Secondary endpoints include pharmacokinetics (PK) of the drugs, as well as the incidence of adverse events (AE) and serious adverse events (SAE). * Phase II: The primary endpoint for Phase II is the Overall Response Rate (ORR), which will be determined by a blinded central imaging review based on RECIST version 1.1 criteria. Secondary endpoints encompass PK (for the initial 20 patients), ORR as assessed by the investigator, progression-free survival (PFS), overall survival (OS), and the overall incidence of adverse events
Вмешательства
- Препарат Ribociclib 400mg
phase 1b cohort 1 - Препарат Ribociclib 600mg
Phase 1b cohort 2 - Препарат Ribociclib 600mg
phase 2
Первичные конечные точки
- Phase 1b part: Dose Limiting Toxicity [Срок оценки: From enrollment to the end of treatment at 4 weeks]
- Phase 2 part: Overall response rate [Срок оценки: From enrollment to the end of treatment at 24 weeks]
Вторичные конечные точки (5)
- Phase 1b part: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Срок оценки: From enrollment to the end of treatment at 4 weeks]
- Phase 1b part: Peak Plasma Concentration (Cmax) [Срок оценки: From enrollment to the end of treatment at 4 weeks]
- Phase 2 part: Overall Response Rate [Срок оценки: From enrollment to the end of treatment at 24 weeks]
- Phase 2 part: PFS [Срок оценки: Time Frame: From enrollment to the end of treatment at 24 weeks]
- Phase 2 part: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Срок оценки: From enrollment to the end of treatment at 24 weeks]
Критерии участия
Критерии включения
- Histologically confirmed invasive breast cancer.
- Hormone receptor-positive (ER positive and/or PgR positive) and HER2-negative disease:
ER positive: ≥1% positive cells or Allred score ≥3.
PgR positive: ≥1% positive cells or Allred score ≥3.
HER2 negative: IHC 0, 1+, or 2+ with no ISH amplification.
- Advanced or recurrent breast cancer (unresectable, recurrent, or Stage IV).
- Age ≥18 years at registration.
- ECOG Performance Status of 0-1.
Критерии исключения
- Symptomatic visceral metastases or deemed unsuitable for endocrine therapy.
- Prior endocrine therapy or chemotherapy for metastatic/recurrent disease.
- Prior CDK4/6 inhibitor exposure (perioperative or metastatic setting).
- Adjuvant endocrine therapy within 35 days before study start.
- Active malignancy other than allowed exceptions (e.g., resected skin cancers, ≥5-year disease-free cancers).
- Hypersensitivity to ribociclib, anastrozole, or their components (including soy/peanut allergy, sugar intolerances).
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Последовательный дизайн
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Япония · 1 центр
- Nagoya City University — Nagoya
Идентификаторы
NCT: NCT07164976 · NCU-002-Ribo(M)