Идёт набор NCT06926868

A Study of Izalontamab Brengitecan Versus Chemotherapy in Participants With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer Ineligible for Anti-PD(L)1 Drugs (IZABRIGHT-Breast01)

Фаза II / Фаза III С лечением Breast Neoplasms

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: Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine.
Кому может быть актуально: Состояния в реестре: Breast Neoplasms. 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, Бразилия +23
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

IZABRIGHT-Breast01: A Randomized, Open-label, Inferentially Seamless Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer (TNBC) or ER-low, HER2-negative BC Who Are Ineligible for Anti-PD1/PD-L1 Treatment

Обзор

The purpose of this study is to assess the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate against EGFR and HER3 with a topoisomerase inhibitor payload versus treatment of physician's choice (TPC) (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine) for the treatment of first-line metastatic triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative BC patients who are not candidates for anti-PD(L)1 therapy and endocrine therapies.

Вмешательства

Препарат Iza-bren
Specified dose on specified days
Препарат Nab-paclitaxel
Specified dose on specified days
Препарат Paclitaxel
Specified dose on specified days
Препарат Capecitabine
Specified dose on specified days
Препарат Carboplatin
Specified dose on specified days
Препарат Gemcitabine
Specified dose on specified days

Первичные конечные точки

Progression-Free Survival (PFS) [Срок оценки: Approximately 31 months from first participant randomization]

Вторичные конечные точки (12)

Overall Survival (OS) [Срок оценки: Approximately up to 57 months from first participant randomization]
Recommended Phase 3 Dose (RP3D) of BMS-986507 [Срок оценки: Approximately 19 months from first participant randomization]
Number of participants with treatment-related Adverse Events (AEs) [Срок оценки: Approximately up to 57 months from first participant randomization]
Number of participants with laboratory abnormalities [Срок оценки: Approximately up to 57 months from first participant randomization]
Number of participants with serious AEs (SAEs) [Срок оценки: Approximately up to 57 months from first participant randomization]
Number of participants with AEs leading to treatment discontinuation, interruption, dose reduction or dose delay [Срок оценки: Approximately up to 57 months from first participant randomization]
Number of deaths [Срок оценки: Approximately up to 57 months from first participant randomization]
Objective Response (OR) [Срок оценки: Approximately 31 months from first participant randomization]
PFS rate [Срок оценки: Approximately 19 months from first participant randomization]
PFS [Срок оценки: Approximately 31 months from first participant randomization]
Disease control rate (DCR) [Срок оценки: Approximately 31 months from first participant randomization]
Duration of Response (DOR) [Срок оценки: Approximately 31 months from first participant randomization]

Критерии участия

Критерии включения

Histologically or cytologically confirmed and documented locally-advanced, recurrent inoperable, or metastatic TNBC (ER < 1%, PgR < 1%, HER2 IHC 0, 1+, or 2+ with ISH negative for HER2 gene amplification) or ER-low, HER2-negative BC (ER and / or PgR 1% to 10%, HER2 IHC 0, 1+, or 2+ with ISH negative for HER2 gene amplification) per ASCO/CAP criteria, based on the most recently analyzed biopsy or other pathology specimen.
Patients with recurrent disease must have experienced disease relapse at least 6 months after finishing their last therapy with curative intent.
Patients with TNBC must be considered ineligible for 1L chemotherapy combination treatment with an anti-PD-1 or an anti-PD-L1 due to either one of the following criteria:

i) Investigator-determined ineligibility based on PD-L1 negative disease determined and documented prior to trial screening as part of SoC; ii) Has experienced disease relapse between 6 to 12 months after the completion of (neo)adjuvant therapy with an anti-PD(L)1; iii) Has a severe auto-immune disease or other contraindication.

Patients with ER-low, HER2-negative BC must be ineligible, in the opinion of the Investigator, for endocrine therapy-based treatments.
No previous systemic therapy in the locally advanced, recurrent inoperable or metastatic setting (ie incurable setting).
Measurable disease by CT or MRI as per RECIST v1.1.
Other protocol-defined Inclusion/Exclusion criteria 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