YL202 Versus Treatment of Physician's Choice in Patients With HR+/HER2- Breast Cancer

Официальное название

A Randomized, Open-label, Multicenter, Phase 3 Study of YL202 Versus Treatment of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy

Обзор

The study will evaluate the safety and efficacy of YL202, when compared with treatment of physician's choice (eribulin, capecitabine, vinorelbine, gemcitabine or sacituzumab govitecan) in participants with unresectable locally advanced, recurrent or metastatic hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer who had failed at least one line of chemotherapy.

Вмешательства

• Препарат YL202
  IV infusion on day 1 of each 21 day cycle
• Препарат Eribulin
  1.4 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle
• Препарат Capecitabine
  1000 or 1250 mg/m2, po, bid, from day 1 to Day 14 of each 21 day cycle
• Препарат Gemcitabine
  1000 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle
• Препарат Vinorelbine
  25 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle
• Препарат Sacituzumab govitecan
  10 mg/kg, IV infusion on day 1 and Day 8 of each 21 day cycle

Первичные конечные точки

• Progression-free survival (PFS) assessed by BIRC per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. [Срок оценки: up to 18 months]

Вторичные конечные точки (6)

• Overall Survival (OS) [Срок оценки: up to 36 months]
• Progression-free survival (PFS) assessed by the investigators per RECIST V 1.1 [Срок оценки: up to 18 months]
• Objective Response Rate (ORR) [Срок оценки: up to 18 months]
• Duration of Response (DoR) [Срок оценки: up to 18 months]
• Disease Control Rate (DCR) [Срок оценки: up to 18 months]
• Adverse Events (AEs) [Срок оценки: up to 36 months]

Критерии участия

Критерии включения

• Have been informed of the study before the start of the study and voluntarily sign name and date on the informed consent form.
• Histologically and/or cytologically confirmed locally advanced or metastatic HR+/HER2- breast cancer who are not candidates for curative surgery or radiotherapy.
• Patients who had failed at least one line of systemic chemotherapy in unresectable locally advanced, recurrent, or metastatic stage.
• Have at least 1 extracranial measurable lesion as a target lesion per RECIST 1.1.
• Tumor tissue samples can be provided at the time of diagnosis of locally advanced or metastatic tumors.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
• Have Adequate organ and bone marrow function within 7 days prior to the first dose.
• Female patients of childbearing potential must agree to use highly effective contraception from screening throughout the duration of the study and for at least 6 months after the last dose of study drug.
• Have a expected survival ≥ 3 months.
• Have ability and willingness to comply with protocol-specified visits and procedures.

Критерии исключения

• Have prior treatment with an agent targeting HER3.
• Have prior treatment with topoisomerase I inhibitor or an ADC that consists of topoisomerase I inhibitor.
• Have insufficient washout period for prior anticancer therapy prior to first dose of the study drug.
• Have major surgery (excluding diagnostic surgery) within 4 weeks prior to the first dose of study drug or anticipation of major surgery during the study.
• Leptomeningeal metastases or carcinomatous meningitis, spinal cord compression.
• Have uncontrolled or clinically significant cardiovascular and cerebrovascular disease.
• Have clinically significant concomitant pulmonary diseases.
• Have uncontrolled pleural effusion, abdominal effusion.
• Have serious infection within 4 weeks prior to the first dose.
• Have a history of severe hypersensitivity reactions to the drug substance, inactive ingredients in the drug product, or other monoclonal antibodies.

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: NCT07461454 · YL202-CN-302-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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