Phase II Clinical Trial of PD-L1 in Combination With Vinorelbine + Cyclophosphamide + Capecitabine (VEX) Metronomic Chemotherapy With or Without Radiotherapy for Advanced Triple-negative Breast Cancer.

Официальное название

Evaluate the Efficacy and Safety of PD-L1 Monoclonal Antibody Combined With VEX Metronomic Chemotherapy With or Without Radiotherapy in Advanced Triple-negative Breast Cancer: a Prospective, Multicenter, Randomized Controlled Phase II Clinical Trial.

Обзор

Phase II clinical trial of PD-L1 in combination with vinorelbine + cyclophosphamide + capecitabine (VEX) metronomic chemotherapy with or without radiotherapy for advanced triple-negative breast cancer.

Вмешательства

• Препарат Adebrelimab + VEX metronomic chemotherapy + radiotherapy
  1、Adebrelimab: 1200mg on day 1, every 3 weeks； 2、VEX Metronomic Chemotherapy: Vinorelbine 20mg orally, once every other day, Q3W Cyclophosphamide 50mg orally, once daily, Q3W Capecitabine 500mg orally, three times daily, Q3W
• Препарат Adebrelimab + VEX metronomic chemotherapy
  1、Adebrelimab: 1200mg on day 1, every 3 weeks； 2、VEX Metronomic Chemotherapy: Vinorelbine 20mg orally, once every other day, Q3W Cyclophosphamide 50mg orally, once daily, Q3W Capecitabine 500mg orally, three times daily, Q3W

Первичные конечные точки

• Progression-Free Survival [Срок оценки: 24 months]

Критерии участия

Subjects are eligible to be included in the study only if all of the following criteria apply:

• Male or female who is 18 years of age or older on the day of signing the informed consent form.
• Subjects with metastatic triple-negative breast cancer, with clear clinical data records; specific reference to the "American Society of Clinical Oncology - College of American Pathologists (ASCO/CAP) guidelines."
• Have received less than or equal to 1 line of chemotherapy for metastatic breast cancer;
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 as assessed within 10 days before the start of study treatment;
• Subjects must have at least one measurable lesion present; specific reference to the "Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)" guidelines;
• Subjects may have previously received treatment with anthracyclines (e.g., doxorubicin, epirubicin) and/or taxanes (e.g., paclitaxel, docetaxel) as follows: a) The subject has used anthracyclines and/or taxanes during adjuvant and/or neoadjuvant therapy before breast cancer recurrence. b) The subject has experienced treatment failure during or after chemotherapy based on anthracyclines and/or taxanes. c) According to the investigator's judgment, the Subject is not suitable for anthracyclines and/or taxanes-based chemotherapy as a first-line treatment option.
• Female subjects are not pregnant, not lactating, and agree to use necessary contraceptive measures.
• Subjects are able to sign an informed consent form to participate in the study.
• Have appropriate organ function, as detailed in Table 1; all screening laboratory tests should be completed within 10 days before the start of study treatment.

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 · 2 центра

• Cancer Hospital, Chinese Academy of Medical Sciences — Пекин
• Cancer Hospital, Chinese Academy of Medical Sciences — Пекин

Идентификаторы

NCT: NCT06771609 · NCC4907

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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