Идёт набор NCT06065748

A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)

Фаза III С лечением Estrogen Receptor-Positive, HER2-Negative Advanced 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: Giredestrant, Fulvestrant, Abemaciclib, Palbociclib.
Кому может быть актуально: Состояния в реестре: Estrogen Receptor-Positive, HER2-Negative Advanced 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, Австрия, Бельгия +32
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 Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4/6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy

Обзор

This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.

Вмешательства

Препарат Giredestrant
Giredestrant 30 milligrams (mg) orally (PO) once a day (QD) on Days 1-28 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity.
Препарат Fulvestrant
Fulvestrant 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent 28-day cycle until PD or unacceptable toxicity.
Препарат Abemaciclib
If chosen by the investigator as the CDK4/6i, participants will receive abemaciclib 150 mg PO twice per day (BID) on Days 1-28 of each 28-day cycle until PD or unacceptable toxicity.
Препарат Palbociclib
If chosen by the investigator as the CDK4/6i, participants will receive palbociclib 125 mg PO QD on Days 1-21 of each 28-day cycle until PD or unacceptable toxicity.
Препарат Ribociclib
If chosen by the investigator as the CDK4/6i, participants will receive ribociclib 600 mg PO QD on Days 1-21 of each 28-day cycle until PD or unacceptable toxicity.
Препарат LHRH Agonist
Only pre/perimenopausal female participants and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist locally approved for use in breast cancer on Day 1 of each 28-day treatment cycle.
Диагностический тест FoundationOne Liquid CDx Assay (F1LCDx)
F1LCDx is a next-generation sequencing (NGS)-based in vitro diagnostic test that detects and analyses genomic alterations in circulating cell-free DNA (cfDNA) isolated from plasma derived from the anti-coagulated peripheral whole blood of cancer patients. It will be used to determine the eligibility of participants requiring confirmation of ESR1 mutation status (mutation detected \[ESR1m\] vs. no mutation detected \[ESR1nmd\]).

Первичные конечные точки

Progression-Free Survival (PFS) in the ESR1 mutation (ESR1m) Subgroup [Срок оценки: From randomization to first occurrence of progressive disease (PD) or death (up to 5 years)]
PFS in the Full Analysis Set (FAS) Population [Срок оценки: From randomization to first occurrence of PD or death (up to 5 years)]

Вторичные конечные точки (12)

PFS in the ESR1 no-mutation-detected (ESR1nmd) Subgroup [Срок оценки: From randomization to first occurrence of PD or death (up to 5 years)]
Overall Survival (OS) [Срок оценки: From randomization until death from any cause (up to 5 years)]
Confirmed Objective Response Rate (cORR) [Срок оценки: From randomization until treatment discontinuation (up to 5 years)]
Duration of Response (DOR) [Срок оценки: From the first occurrence of a documented objective response to PD or death (up to 5 years)]
Clinical Benefit Rate (CBR) [Срок оценки: From randomization until treatment discontinuation (up to 5 years)]
Time to Chemotherapy [Срок оценки: From randomization until the start of chemotherapy or death (up to 5 years)]
Time to Confirmed Deterioration (TTCD) in Pain Severity [Срок оценки: From randomization until end of follow-up (up to 5 years)]
TTCD in Pain Presence and Interference [Срок оценки: From randomization until end of follow-up (up to 5 years)]
TTCD in Physical Functioning [Срок оценки: From randomization until end of follow-up (up to 5 years)]
TTCD in Role Functioning [Срок оценки: From randomization until end of follow-up (up to 5 years)]
TTCD in Global Health Status/Quality of Life [Срок оценки: From randomization until end of follow-up (up to 5 years)]
Incidence and Severity of Adverse Events [Срок оценки: From Baseline until 28 days after the final dose of study treatment (up to 5 years)]

Критерии участия

Критерии включения

Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
Documented estrogen receptor-positive (ER+), HER2-negative (HER2-) tumor assessed locally on the most recent tumor biopsy (or an archived tumor sample if a recent tumor sample is not available for testing)
Confirmed ESR1 mutation status (ESR1m versus ESR1nmd) in baseline circulating tumor DNA (ctDNA) through central laboratory testing
Resistance to prior adjuvant endocrine therapy (ET), which is defined as having relapsed with prior standard adjuvant ET, on-treatment after >/=12 months or off-treatment within 12 months of completion. Prior use of adjuvant CDK4/6i is allowed (if relapse occurred >/=12 months since completion).
No prior systemic anti-cancer therapy for advanced disease
Measurable disease as defined per RECIST v.1.1 or non-measurable (including bone-only) disease
Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
For pre/perimenopausal women and for men: willing to undergo and maintain treatment with approved LHRH agonist therapy (as per local guidelines) for the duration of study treatment

Критерии исключения

Prior systemic therapy (e.g., prior chemotherapy, immunotherapy, or biologic therapy) for locally advanced unresectable or metastatic breast cancer
Prior treatment with another SERD (e.g., fulvestrant, oral SERDs) or novel ER-targeting agents
Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
Active cardiac disease or history of cardiac dysfunction
Clinically significant history of liver disease

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