Меню
Набор скоро начнётся NCT07556848

A Study of 9MW2821 Versus Chemotherapy in Participants With Previously Treated Locally Advanced or Metastatic Triple-Negative Breast Cancer

Фаза III С лечением Locally Advanced or Metastatic Triple-negative 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: 9MW2821, Chemotherapy.
Кому может быть актуально
Состояния в реестре: Locally Advanced or Metastatic Triple-negative Breast Cancer. Базовые параметры: 18 лет — 75 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
Китай
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

A Randomized, Open-label, Phase 3 Study to Evaluate 9MW2821 Versus Investigator's Choice of Chemotherapy in Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer Who Have Previously Received Taxane-based Chemotherapy With or Without Immunotherapy and an Antibody-drug Conjugate With a Topoisomerase Inhibitor Payload

Обзор

The purpose of this study is to compare the efficacy and safety of 9MW2821 versus investigator's choice of chemotherapy in participants with locally advanced or metastatic triple-negative breast cancer who have previously received taxane-based chemotherapy with or without immunotherapy and an antibody-drug conjugate with a topoisomerase inhibitor payload

Вмешательства

  • Препарат 9MW2821
    Subjects will receive intravenous (IV) infusion of 9MW2821 as per protocol
  • Препарат Chemotherapy
    Participants will receive investigator's choice of chemotherapy determined prior to randomization from 1 of the 4 allowed regimens as per protocol: eribulin, or vinorelbine or capecitabine or gemcitabine.

Первичные конечные точки

  • Overall Survival [Срок оценки: Up to approximately 2 years]
Вторичные конечные точки (7)
  • Objective Response Rate per investigator [Срок оценки: Up to approximately 2 years]
  • Duration of Response per investigator [Срок оценки: Up to approximately 2 years]
  • Time to response per investigator [Срок оценки: Up to approximately 2 years]
  • Disease Control Rate per investigator [Срок оценки: Up to approximately 2 years]
  • Progression Free Survival per investigator [Срок оценки: Up to approximately 2 years]
  • Incidence of adverse events [Срок оценки: Up to approximately 2 years]
  • Incidence of Anti-Drug Antibody (ADA) [Срок оценки: Up to approximately 2 years]

Критерии участия

Критерии включения

  • Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form.
  • Male or female subjects aged 18 to 75 years (including 18 and 75 years).
  • ECOG 0-1.
  • Histopathological diagnosed triple-negative breast cancer.
  • Patient has previously received taxane-based chemotherapy with or without immunotherapy and an antibody-drug conjugate with a topoisomerase inhibitor payload.
  • Suitable for one of active comparator chemotherapy assessed by investigator.
  • An archival tumor tissue sample or a fresh tissue sample should be provided.
  • Life expectancy of ≥ 12 weeks.
  • Subjects must have measurable disease according to RECIST (version 1.1).
  • Adequate organ functions.
  • Sexually active fertile participants, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.

Критерии исключения

  • Preexisting treatment related toxicity Grade ≥ 2 and Grade ≥ 3 immune related adverse reactions.
  • Preexisting peripheral neuropathy Grade ≥ 2.
  • Hemoglobin A1C (HbA1c) ≥ 8%.
  • Has ocular conditions or symptoms that may increase the risk of the study.
  • History of ILD or pneumotitis, other severe or uncontrolled disease or central nervous system metastases and/or meningeal metastasis.
  • Previous medication does not meet the requirements.
  • Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness.
  • Documented history of pulmonary embolism or clinically significant cardiac or cerebrovascular diseases .
  • Active autoimmune disease.
  • History of another malignancy .
  • Pleural, abdominal, or pericardial effusion with clinical symptoms or that require drainage treatment.
  • Not suitable to receive study treatment for other conditions as per investigator.

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

Центры проведения

Китай · 1 центр
  • Fudan University Shanghai Cancer Center — Шанхай

Идентификаторы

NCT: NCT07556848 · 9MW2821-CP305

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗