Идёт набор NCT06016738

OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer

Фаза III С лечением Breast Cancer Advanced Breast Cancer Metastatic Breast Cancer ER Positive 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: Palazestrant, Fulvestrant, Anastrozole, Letrozole.
Кому может быть актуально: Состояния в реестре: Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer, ER Positive 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 +21
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 3 Randomized, Open-Label Study of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 4/6 Inhibitor Therapy (OPERA-01)

Обзор

This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a CDK4/6 inhibitor.

Подробное описание

This is an international, multicenter, randomized, open-label, active-controlled, phase 3 clinical trial. The purpose of this trial is to compare the safety and efficacy of palazestrant (OP-1250) as a single agent to the standard of care endocrine therapy: either fulvestrant or an aromatase inhibitor (anastrozole, letrozole, or exemestane).

This trial is seeking adult participants with ER+, HER2- advanced or metastatic breast cancer whose disease has relapsed or progressed on 1 or 2 prior lines of standard-of-care endocrine therapy for metastatic breast cancer. Prior lines of therapy must include one line of endocrine therapy in combination with a CDK 4/6 inhibitor. In the dose-selection part of the trial, approximately 120 participants will be randomized to one of the two doses of palazestrant or to the standard-of-care endocrine therapy. Thereafter, approximately 390 participants will be randomized to palazestrant at the selected dose or to the standard-of-care endocrine therapy.

Вмешательства

Препарат Palazestrant
Participants will be treated with palazestrant once daily on a 4 week (28 day) cycle. Doses evaluated in the dose-selection part will be 120 mg once daily and 90 mg once daily.
Препарат Fulvestrant
Participants will be treated with fulvestrant on C1D1, C1D15, and then on Day 1 of every subsequent 4 week (28 day) cycle
Препарат Anastrozole
Participants will be treated with anastrozole once daily on a 4 week (28 day) cycle
Препарат Letrozole
Participants will be treated with letrozole once daily on a 4 week (28 day) cycle
Препарат Exemestane
Participants will be treated with exemestane once daily on a 4 week (28 day) cycle

Первичные конечные точки

Dose-Selection Part: Incidence of adverse events [Срок оценки: From Date of Randomization up to 16 weeks]
Dose-Selection Part: Incidence of dose reduction [Срок оценки: From Date of Randomization up to 16 weeks]
Dose-Selection Part: Incidence of drug discontinuation [Срок оценки: From Date of Randomization up to 16 weeks]
Trial: Progression-Free Survival (PFS) [Срок оценки: From Date of Randomization until Disease Progression or Death Due to Any Cause (estimated as up to 2 years)]

Вторичные конечные точки (1)

Trial: Overall Survival (OS) [Срок оценки: From Date of Randomization until Death Due to Any Cause (estimated as up to 4 years)]

Критерии участия

Критерии включения

Adult female or male participants.
ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy.
Evaluable disease (measurable disease or bone-only disease).
Previously received a CDK4/6 inhibitor in combination with an endocrine therapy in the advanced setting. One additional line of ET as a monotherapy is allowed. Duration of the most recent prior ET must be at least 6 months.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate hematologic, hepatic, and renal functions.
Female participants can be pre-, peri- or postmenopausal.
Male and pre- or peri-menopausal female participants must be willing to take a GnRH (or LHRH) agonist.

Критерии исключения

Symptomatic visceral disease, imminent organ failure, or any other reason that makes the participant ineligible for endocrine monotherapy.
Previously received chemotherapy in the advanced/metastatic setting.
Previously received treatment with elacestrant or an investigational estrogen receptor-directed therapy.
History of allergic reactions to study treatment.
Any contraindications to the selected standard-of-care endocrine therapy in the local prescribing information.
Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment.
Clinically significant comorbidities such as significant cardiac or cerebrovascular disease, gastrointestinal disorders that could affect absorption 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: Открытое
Основная цель: Лечение