Идёт набор NCT06492616

A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence

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: Elacestrant, Anastrozole, Letrozole, Exemestane.
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, Австрия, Бельгия +23
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

Elacestrant Versus Standard Endocrine Therapy in Women and Men With Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer With High Risk of Recurrence-A Global, Multicenter, Randomized, Open-label Phase 3 Study

Обзор

The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.

Вмешательства

Препарат Elacestrant
Administered as oral tablets
Препарат Anastrozole
Administered as oral tablets
Препарат Letrozole
Administered as oral tablets
Препарат Exemestane
Administered as oral tablets
Препарат Tamoxifen
Administered as oral tablets

Первичные конечные точки

Invasive Breast Cancer-Free Survival (IBCFS) [Срок оценки: Up to 5 years]

Вторичные конечные точки (10)

Distant Relapse-Free Survival (DRFS) [Срок оценки: Up to 5 years]
Overall Survival (OS) [Срок оценки: Up to 5 years]
Invasive Disease-Free Survival (IDFS) [Срок оценки: Up to 5 years]
Number of Participants With Adverse Events (AEs) [Срок оценки: Up to 5 years plus 28 days]
Change from Baseline in Global Health Status Quality of Life Scale score, as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) [Срок оценки: Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5]
Change from Baseline in the Physical Functioning Sub-Scale Score as Assessed by EORTC QLQ-C30 [Срок оценки: Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5]
Change From Baseline in the Breast Cancer Endocrine Therapy Symptoms Sub-Scale Score, as Assessed by the EORTC Quality of Life Breast Cancer Questionnaire module (EORTC QLQ-BR42) [Срок оценки: Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5]
Change From Baseline in Side Effects, as Assessed by the Question 168 of the European Organization for the Research and Treatment of Cancer Question Library (EORTC Q168) [Срок оценки: Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5]
Area Under the Plasma Concentration Versus Time Curve at Steady State (AUCss) of Elacestrant [Срок оценки: Predose up to 4 hours postdose]
Maximum Plasma Concentration at Steady State (Cmaxss) of Elacestrant [Срок оценки: Predose up to 4 hours postdose]

Критерии участия

Критерии включения

Histopathologically or cytologically confirmed ER-positive (≥ 10% by immunohistochemistry \[IHC\]), HER2-negative \[IHC = 0, 1+, 2 and in situ hybridization \[ISH\]-negative)\] on tumor biopsy or final surgical pathology specimen early stage resected invasive breast cancer without evidence of recurrence or distant metastases, per local laboratory, according to the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
Participants considered at high risk of recurrence at initial staging
Participants who have received at least 24 months but not more than 60 months of endocrine therapy (AIs or tamoxifen) with or without a CDK 4 and CKD 6 inhibitor (CDK4/6i)
Participants who received prior CDK4/6i or a poly adenosine diphosphate-ribose polymerase (PARP) inhibitor must have already completed or discontinued these treatments.

Критерии исключения

Participants with inflammatory breast cancer
History of any prior (ipsilateral and/or contralateral) invasive breast cancer
Participant with history of malignancy within 3 years of the date of randomization, except for adequately treated basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix
Participants who have had more than a 6-month continuous interruption of prior SoC adjuvant endocrine therapy or who are off current adjuvant endocrine therapy more than 6 months prior to randomization

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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