Идёт набор NCT05894239

A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer

Фаза III С лечением 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: Inavolisib, Phesgo, Placebo, Taxane-based Chemotherapy.
Кому может быть актуально: Состояния в реестре: Metastatic 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, Бразилия +24
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 in Combination With Phesgo Versus Placebo in Combination With Phesgo As Maintenance Therapy After First Line Induction Therapy in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer

Обзор

This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).

Вмешательства

Препарат Inavolisib
Participants will receive an inavolisib tablet to be taken orally (PO), once a day (QD), on Days 1-21 of each 21-day cycle, beginning on Day (D) 1 of Cycle (C) 1 of maintenance treatment.
Препарат Phesgo
Phesgo will be administered to participants subcutaneously every 3 weeks (Q3W) on D1 of each 21-day cycle.
Препарат Placebo
Inavolisib-matching tablet taken PO QD on Days 1-21 of each 21-day cycle, beginning on D1 C1 of maintenance treatment.
Препарат Taxane-based Chemotherapy
During the induction therapy phase, the investigator's choice of taxane-based chemotherapy will be administered after Phesgo.
Препарат Optional Endocrine Therapy of Investigator's Choice
Optional endocrine therapy (ET) is allowed at the discretion of the investigator, based on the standard of care. Allowed ETs are tamoxifen, or one of the specified third-generation aromatase inhibitor (AI \[anastrozole, letrozole, or exemestane\]), or fulvestrant. The investigator will determine and supply the appropriate luteinizing hormone-releasing hormone (LHRH) agonist locally approved for use in breast cancer. The LHRH agonist will be administered according to local prescribing information

Первичные конечные точки

Investigator-Assessed Progression-Free Survival (PFS) [Срок оценки: Up to approximately 40 months]

Вторичные конечные точки (8)

Overall Survival (OS) [Срок оценки: Up to approximately 111 months]
Investigator-Assessed Objective Response Rate (ORR) [Срок оценки: Up to approximately 111 months]
Investigator-Assessed Duration of Response (DOR) [Срок оценки: Up to approximately 111 months]
Investigator-Assessed Clinical Benefit Rate (CBR) [Срок оценки: Up to approximately 111 months]
Investigator-Assessed PFS2 [Срок оценки: Up to approximately 111 months]
Mean and Mean Changes from Baseline Score in Function and Health-Related Quality of Life (HRQoL) [Срок оценки: Day 1 of Cycles 1 and 2 and beyond, 30-day safety follow up visit, post-treatment tumor assessment follow-up with PRO collection and survival follow up visit every 6 months (up to 111 months). Each cycle is 21 days.]
Percentage of Participants with Adverse Events [Срок оценки: Day 1 until 30 days after the final dose of study treatment (up to approximately 111 months). Each cycle is 21 days.]
Plasma Concentration of Inavolisib at Specified Timepoints [Срок оценки: Day 1 of Cycles 1 and 4. Each cycle is 21 days.]

Критерии участия

Критерии включения

Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection
Confirmation of HER2 biomarker eligibility based on valid results from central testing of tumor tissue documenting HER2-positivity
Confirmation of PIK3CA-mutation biomarker eligibility based on valid results from central testing of tumor tissue documenting PIK3CA-mutated tumor status
Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of >= 6 months
LVEF (left ventricular ejection fraction) of at least 50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
Adequate hematologic and organ function prior to initiation of study treatment

Критерии исключения

Prior treatment in the locally advanced or metastatic setting with any PI3K, AKT, or mTOR inhibitor or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway
Any prior systemic non-hormonal anti-cancer therapy for locally advanced or metastatic HER2-positive breast cancer prior to initiation of induction therapy
History or active inflammatory bowel disease
Disease progression within 6 months of receiving any HER2-targeted therapy
Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
Participants with active HBV infection
Clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis
Symptomatic active lung disease, including pneumonitis or interstitial lung disease
Any history of leptomeningeal disease or carcinomatous meningitis
Serious infection requiring IV antibiotics within 7 days prior to Day 1 of Cycle 1
Any concurrent ocular or intraocular condition that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition
Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye

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

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