Идёт набор NCT06790693

A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, 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: Inavolisib, Placebo, CDK4/6i, Letrozole.
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, Бразилия, Канада +15
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 III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

Обзор

This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer (ABC).

Вмешательства

Препарат Inavolisib
Participants will receive oral inavolisib once daily (QD).
Препарат Placebo
Participants will receive oral placebo QD.
Препарат CDK4/6i
Participants will receive CDK4/6i on either Days 1-21 or Days 1-28 of each 28-day cycle.
Препарат Letrozole
Participants will receive oral letrozole QD.

Первичные конечные точки

Progression-Free Survival (PFS) [Срок оценки: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 7 years)]

Вторичные конечные точки (12)

Overall Survival (OS) [Срок оценки: From randomization to death from any cause (up to 7 years)]
Investigator-assessed Objective Response Rate (ORR) [Срок оценки: Up to 7 years]
Investigator-assessed Duration of Response (DOR) [Срок оценки: From the first occurrence of a confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 7 years)]
Investigator-assessed Clinical Benefit Rate (CBR) [Срок оценки: Up to 7 years]
Time to Confirmed Deterioration (TTCD) in Pain [Срок оценки: From baseline until end of follow-up (up to 7 years)]
TTCD in Physical Function [Срок оценки: From baseline until end of follow-up (up to 7 years)]
TTCD in Role Function [Срок оценки: From baseline until end of follow-up (up to 7 years)]
TTCD in Global Health Status [Срок оценки: From baseline until end of follow-up (up to 7 years)]
Percentage of Participants with Adverse Events [Срок оценки: From baseline until end of follow-up (up to 7 years)]
Number of Participants Reporting Presence, Frequency, Severity, and/or Degree of Interference with Daily Function of Symptomatic Treatment Toxicities Assessed by NCI Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) [Срок оценки: Up to 7 years]
Number of Participants Reporting Each Response Option for Treatment Side-effect Bother Single-item General Population, Question 5 (GP5) from the Functional Assessment of Cancer Therapy-General Questionnaire; (FACT-G) [Срок оценки: Up to 7 years]
Change from Baseline in Symptomatic Treatment Toxicities as Assessed Through use of the PRO-CTCAE [Срок оценки: Baseline up to 7 years]

Критерии участия

Критерии включения

Women or men with histologically or cytologically confirmed carcinoma of the breast
Documented ER-positive and/or progesterone receptor-positive tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
Documented HER2-negative tumor according to ASCO/CAP guidelines
De-novo HR+ , HER2- ABC, or, alternatively, relapsed HR+ , HER2- ABC after at least 2 years of standard neoadjuvant/adjuvant endocrine therapy without disease progression during that treatment and disease-free interval of at least 1 year since the completion of that treatment
Participants who have bilateral breast cancers which are both HR-positive and HER2-negative
Confirmation of biomarker eligibility
Consent to provide fresh or archival tumor tissue specimen
Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Adequate hematologic and organ function within 14 days prior to initiation of study treatment

Критерии исключения

Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
Metaplastic breast cancer
Any prior systemic therapy for locally advanced unresectable or metastatic breast cancer
Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
Any history of leptomeningeal disease or carcinomatous meningitis
Known and untreated, or active CNS metastases. Participants with a history of treated CNS metastases are eligible
Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye
Symptomatic active lung disease
History of or active inflammatory bowel disease
Any active bowel inflammation
Prior hematopoietic stem cell or bone marrow transplantation
Treatment with strong cytochrome P450 (CYP) 3A4 inhibitors or strong CYP3A4 inducers within 4 weeks or 5 drug-elimination half-lives, prior to initiation of study treatment

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: Двойное слепое
Основная цель: Лечение