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Идёт набор NCT07368998

To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer

Фаза II 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: Inavolisib, Fulvestrant.
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
США, Аргентина, Австралия, Бельгия, Мексика +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

A Phase II, Randomized, Open-Label Study Evaluating Two Inavolisib Dose Levels in Combination With Fulvestrant in Participants With PIK3CA-Mutated, HR-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

Обзор

The purpose of this study is to evaluate the efficacy and safety of inavolisib in combination with fulvestrant compared with inavolisib in combination with fulvestrant in participants with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer (LA/mBC) in the post-cyclin-dependent kinase inhibitor (CDKi) setting.

Вмешательства

  • Препарат Inavolisib
    Participants will receive Inavolisib as per the schedule given in the protocol.
  • Препарат Fulvestrant
    Participants will receive Fulvestrant as per the schedule given in the protocol.

Первичные конечные точки

  • Percentage of Participants With Objective Response Rate (ORR) [Срок оценки: Up to approximately 2 years]
  • Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) [Срок оценки: Up to approximately 2 years]
Вторичные конечные точки (10)
  • Duration of Response (DOR) [Срок оценки: Up to approximately 2 years]
  • Time to Response (TTR) [Срок оценки: Up to approximately 2 years]
  • Progression-free Survival (PFS) [Срок оценки: Up to approximately 2 years]
  • Percentage of Participants With Treatment Discontinuation due to Adverse Events [Срок оценки: Up to approximately 2 years]
  • Number of Participants Reporting Presence, Frequency, Severity and/or Degree of Interference With Daily Activities of Symptomatic Treatment Toxicities as Assessed by NCI Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) [Срок оценки: Up to approximately 2 years]
  • Percentage of Participants Reporting Presence and Frequency of Selected Hyperglycemia Symptoms as Assessed by European Organisation for Research and Treatment of Cancer (EORTC) IL382 [Срок оценки: Up to approximately 2 years]
  • Percentage of Participants Reporting Each Response Option at Each Time Point for the Treatment Side-Effect Bother Item General Population, Question 5 (GP5) From the Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire [Срок оценки: Up to approximately 2 years]
  • Change from Baseline in Symptomatic Treatment-Related Toxicities as Assessed Through use of the PRO-CTCAE [Срок оценки: Baseline, Up to approximately 2 years]
  • Change from Baseline in Selected Hyperglycemia Symptoms as Assessed by EORTC IL382 [Срок оценки: Baseline, Up to approximately 2 years]
  • Change from Baseline in Treatment Side-effect Bother as Assessed Through use of the FACT-G GP5 Item [Срок оценки: Baseline, Up to approximately 2 years]

Критерии участия

Критерии включения

  • Documented ER +/ HER2- tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
  • Disease progression after or during treatment with a combination of CDK4/6i and endocrine therapy: <= 1 prior lines of systemic therapy in the locally advanced (recurrent or progressed) or metastatic setting
  • Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
  • Participants for whom endocrine-based therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines
  • Confirmation of biomarker eligibility: presence of >= 1 study-eligible PIK3CA mutation
  • Life expectancy of > 6 months
  • Ability, in the investigator's judgment, and willingness to comply with all study -related procedures, including completion of patient-reported outcomes

Критерии исключения

  • Metaplastic breast cancer
  • Prior treatment with chemotherapy in the recurrent locally advanced/metastatic setting
  • Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
  • Prior treatment with PI3K/Akt/mTOR inhibitors in the recurrent locally advanced/metastatic setting
  • Requirement for daily supplemental oxygen
  • Symptomatic active lung disease, including pneumonitis

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

Аргентина · 6 центров
  • Instituto de Oncologia de Rosario — Rosario
  • Centro Oncologico Korben — Ciudad Autonoma Buenos Aires
  • Hospital Privado - Centro Medico de Córdoba — Córdoba
  • Centro Oncologico Riojano Integral (CORI) — La Rioja
  • Hospital Provincial del Centenario — Rosario
  • Centro Oncológico de Excelencia — San Juan
Бельгия · 4 центра
  • Cliniques Universitaires St-Luc — Brussels
  • Jessa Zkh (Campus Virga Jesse) — Hasselt
  • UZ Leuven Gasthuisberg — Leuven
  • Clinique Ste-Elisabeth — Namur
Мексика · 4 центра
  • Hospital Civil de Guadalajara Fray Antonio Alcalde — Guadalajara
  • RENATI INNOVATION S.A.P.I. de C.V — Guadalajara
  • Centro de Infusion Tratamiento e Investigacion Oncologica S DE R — Queretaro Qro
  • CENEIT Oncologicos — Mexico City
Испания · 4 центра
  • Hospital Universitari Vall d'Hebron;Oncology — Barcelona
  • Hospital Universitario San Cecilio — Granada
  • Hospital Universitario 12 De Octubre — Madrid
  • Hospital Clinico Universitario de Valencia — Valencia
Turkey (Türkiye) · 4 центра
  • Bagcilar Medipol Mega Universitesi Hastanesi — Bağcılar
  • Adana Baskent University Hospital — Adana
  • Memorial Ankara Hastanesi — Ankara
  • Medical Park Seyhan Hospital — Seyhan
США · 3 центра
  • Los Angeles Cancer Network — Los Angeles
  • Cancer Specialists of North Florida — Jacksonville
  • Astera Cancer Care East Brunswick — East Brunswick
Австралия · 3 центра
  • Blacktown Hospital — Blacktown
  • Coffs Harbour Health Campus — Coffs Harbour
  • Bendigo Cancer Centre — Bendigo
Великобритания · 3 центра
  • Blackpool Victoria Hospital — Blackpool
  • Princess Alexandra Hospital — Harlow
  • Mount Vernon Cancer Centre — Northwood, Middlesex

Идентификаторы

NCT: NCT07368998 · WO46063 · 2025-522805-39-00

Первоисточники (государственные реестры)

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