Famitinib in Combination With Camrelizumab and TPC in The First-line Treatment of Immunomodulatory Locally Advanced or Metastatic TNBC.

Официальное название

An Open, Randomized Phase III Study of Famitinib With Camrelizumab Plus Treatment of Physician's Choice (TPC) Versus Camrelizumab Plus TPC in The First-line Treatment of Immunomodulatory Locally Advanced or Metastatic Triple-negative Breast Cancer

Обзор

The study is being conducted to evaluate the Famitinib with Camrelizumab plus treatment of physician's choice (TPC) versus Camrelizumab plus TPC in Patients with Unresectable Locally Advanced or Metastatic Immunomodulatory Triple Negative Breast Cancer.

Вмешательства

• Препарат Famitinib
  TKI
• Препарат Camrelizumab
  PD1 inhibitor
• Препарат nab-Palitaxel/Capecitabine/Eribulin Mesylate/Carboplatin
  TPC

Первичные конечные точки

• PFS [Срок оценки: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 1.5 years)]

Вторичные конечные точки (4)

• ORR [Срок оценки: max 6 months]
• DoR [Срок оценки: max 6 months]
• CBR [Срок оценки: max 6 months]
• OS [Срок оценки: approximately 3 years]

Критерии участия

Критерии включения

• ECOG Performance Status of 0-1
• Expected lifetime of not less than three months
• Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
• Cancer stage: recurrent or metastatic breast cancer; Local recurrence be confirmed by the researchers could not be radical resection.
• Adequate hematologic and end-organ function, laboratory test results.
• Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) • Patients had received no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer

Критерии исключения

• Previous received anti-VEGFR small molecule tyrosine kinase inhibitors (e.g. famitinib, sorafenib, Sunitinib, regorafenib, etc.) for treatment of the patients .
• A history of bleeding, any serious bleeding events.
• Important blood vessels around tumors has been infringed and high risk of bleeding.
• Coagulant function abnormality
• artery/venous thromboembolism event
• History of autoimmune disease
• Positive test for human immunodeficiency virus
• Active hepatitis B or hepatitis C
• Uncontrolled pleural effusion and ascites • Known central nervous system (CNS) disease.
• Long-term unhealing wound or incomplete healing of fracture
• urine protein ≥2+ and 24h urine protein quantitative > 1 g.
• Pregnancy or lactation.
• Thyroid dysfunction.
• Peripheral neuropathy grade ≥2.
• People with high blood pressure;
• A history of unstable angina;
• New diagnosis of angina pectoris.
• Myocardial infarction incident .

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

• Breast cancer institute of Fudan University Cancer Hospital — Шанхай

Идентификаторы

NCT: NCT05760378 · BCTOP-T-M02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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