A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer

Официальное название

A Randomized, Open-Label, Multicenter Phase 3 Study of SKB264 Versus Investigator's Choice Chemotherapy as First-Line Treatment in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer

Обзор

The aim of the study is to evaluate the efficacy and safety of SKB264 as first-line treatment for patients with unresectable recurrent or metastatic triple-negative breast cancer (TNBC) whose tumors do not express programmed cell death ligand 1 (PD-L1) or in patients with PD-L1 positive tumors who received prior anti-programmed cell death 1 (PD-1)/PD-L1 inhibitor in early setting

Подробное описание

This is a randomized, open-label, multicenter, Phase 3 study to evaluate the efficacy and safety of SKB264 versus investigator's choice chemotherapy as first-line treatment for patients with unresectable recurrent or metastatic TNBC whose tumors do not express PD-L1 or in patients with PD-L1 positive tumors who received prior anti-PD-1/PD-L1 inhibitor in early setting.

Вмешательства

• Препарат SKB264
  IV Infusion
• Препарат Paclitaxel
  IV Infusion.
• Препарат Nab-paclitaxel
  IV infusion.
• Препарат Capecitabine
  Tablet. Oral route of administration.
• Препарат Eribulin
  IV infusion.
• Препарат Carboplatin
  IV infusion.

Первичные конечные точки

• Overall Survival (OS) [Срок оценки: Randomization up to approximately 40 months]
• Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) [Срок оценки: Randomization up to approximately 28 months]

Вторичные конечные точки (6)

• Objective Response Rate (ORR) [Срок оценки: Randomization up to approximately 28 months]
• Duration of Response (DoR) [Срок оценки: Randomization up to approximately 28 months]
• Progression-Free Survival (PFS) assessed by Investigator [Срок оценки: Randomization up to approximately 28 months]
• Disease control rate (DCR) [Срок оценки: Randomization up to approximately 28 months]
• Time to Response (TTR) [Срок оценки: Randomization up to approximately 28 months]
• Adverse events(AEs) and severe adverse events (SAEs) [Срок оценки: AEs should be collected from signing the informed consent form (ICF) until 30 days after the last dose]

Критерии участия

Критерии включения

• Histologically and/or cytologically confirmed TNBC.
• De novo metastatic or relapsed ≥ 6 months post completion of treatment with curative intent.
• No prior systemic anti-cancer therapy for unresectable recurrent or metastatic disease.
• Participants whose tumours are PD-L1-negative, or participants whose tumors are PD-L1 positive and have relapsed after prior anti-PD-1/PD-L1 inhibitor for early-stage disease.
• At least one measurable lesion per RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no worsening within 2 weeks prior to randomization.
• A life expectancy of at least 3 months.
• Eligible for the chemotherapy options listed as investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, eribulin, or carboplatin) as assessed by the investigator.
• Adequate organ and bone marrow function.

Критерии исключения

• Active second malignancy.
• Uncontrolled or clinical significant cardiovascular disease.
• History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
• Active infection requiring systemic therapy within 2 weeks of randomization.
• Active hepatitis B or hepatitis C virus infection.
• Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
• Known hypersensitivity to SKB264 or its excipients.
• Previously received TROP2-targeted therapy or topoisomerase 1 inhibitors.
• Prior treatment with the same investigator's choice chemotherapy (except taxane).
• Pregnant or lactating women.

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: NCT06279364 · SKB264-Ⅲ-11

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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