A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE)

Официальное название

A Randomized, Open-label, Phase III Study of SIM0270 Combined With Everolimus Versus Treatment of Physician's Choice in Patients With CDK4/6 Inhibitors Previously Treated , ER+/HER2- Locally Advanced or Metastatic Breast Cancer

Обзор

This Phase III, randomized, open label, multicenter study will evaluate the efficacy and safety of SIM0270 combined with everolimus compared to physician's choice of treatment in subjects with ER+/HER2- locally advanced or metastatic breast cancer who have had previous treatment with CDK4/6 inhibitor.

Вмешательства

• Препарат SIM0270
  Experimental
• Препарат Everolimus (Afinitor®)
  Experimental and Active comparator
• Препарат Exemestane tablets
  Active Comparator
• Препарат Fulvestrant injection
  Active Comparator

Первичные конечные точки

• Progression free survival(PFS) , as assessed by blinded independent review committee(BIRC) according to RECIST1.1 [Срок оценки: 2 year]

Вторичные конечные точки (12)

• Progression free survival(PFS) , as assessed by investigator according to RECIST1.1 [Срок оценки: 2 year]
• Overall Survival (OS) [Срок оценки: 3 year]
• The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) [Срок оценки: 3 year]
• Blood concentrations [Срок оценки: At five specified time points of the first 6 cycles (each cycle is 28 days)]
• Objective Response Rate (ORR) by investigator [Срок оценки: 2 year]
• Objective Response Rate (DOR) by investigator [Срок оценки: 2 year]
• ORR by BIRC [Срок оценки: 2 year]
• DOR by BIRC [Срок оценки: 2 year]
• Clinical benefit rate(CBR) by investigator [Срок оценки: 2 year]
• CBR by BIRC [Срок оценки: 2 year]
• Time To Progression (TTP) by investigator [Срок оценки: 2 year]
• Time To Progression (TTP) by BIRC [Срок оценки: 2 year]

Критерии участия

Критерии включения

• Subjects with histologically or cytologically confirmed ER+/HER2- locally advanced or metastatic breast cancer
• Subjects must have at least one RECIST 1.1 measurable disease and /or at least 1 lytic or mixed (lytic + sclerotic) bone lesion
• For women who are post menopausal must meet criteria as defined in the protocol.For women who are premenopausal or perimenopausal and for men: treatment with approved LHRH agonist therapy for screening period and the duration of study treatment
• Have disease that has demonstrated progression on or after prior treatment:

• subjects had received 1 to 2 endocrine therapies in the locally advanced or metastatic setting with disease recurrence/disease progression while being treated with adjuvant endocrine therapy for ≥ 24 months and/or endocrine therapy in the locally advanced or metastatic setting, and derived a clinical benefit from therapy
• subjects had received ≤ 1 chemotherapy in the locally advanced or metastatic setting.
• Eastern Cooperative Oncology Group Performance Status 0-1
• Adequate organ function

Критерии исключения

• Prior treatment with a oral selective estrogen receptor degrader (SERD) or other investigational-ER-directed therapy, or any PI3K-AKI-mTOR inhibitors
• Treatment with any investigational therapy within 28 days prior to study treatment.Treatment with moderate/strong CYP3A inhibitors or P-gP inhibitor within 14 days prior to first dose or moderate/strong CYP3A inducer within 28 days prior to first dose
• Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
• Active or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
• Active cardiac disease or history of cardiac dysfunction, as defined in the protocol
• Pregnant or breastfeeding

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

Китай · 60 центров

• The First Affiliated Hispital of Bengbu Medical University — Bengbu
• Anhui Provincial Cancer Hospital — Хэфэй
• The First Affiliated Hispital of Anhui Medical University — Хэфэй
• Maanshan People's Hospital — Maanshan
• Beijing Cancer Hospital — Пекин
• The First Medical Center of PLA Ggeneral Hospital — Пекин
• The First Affiliated Hospital of Chongqing Medical University — Чунцин
• The Second Affiliated Hospital of Chongqing Medical University — Чунцин
• … и ещё 52 центра

Идентификаторы

NCT: NCT06680921 · SIM0270-301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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