Toripalimab Combined With Anthracycline-free or Anthracycline-containing Chemotherapy as Neoadjuvant Chemotherapy for Early Triple Negative Breast Cancer

Официальное название

A Prospective, Randomized Controlled, Multicenter Phase II Clinical Study of Toripalimab Combined With PCb-EC Regimen (Albumin Paclitaxel + Carboplatin Followed by Epirubicin + Cyclophosphamide) or PCb Regimen (Albumin Paclitaxel + Carboplatin) as Neoadjuvant Therapy for Triple-Negative Breast Cancer

Обзор

This study aims to evaluate the efficacy and safety of a PD-1 inhibitor combined with different chemotherapy regimens (PCb-EC and PCb), in order to develop a superior and well-tolerated neoadjuvant therapeutic strategy for patients with triple-negative breast cancer.

Вмешательства

• Препарат Toripalimab
  Toripalimab 240mg every cycle
• Препарат PCb-EC
  Albumin Paclitaxel + Carboplatin\*4 Followed by Epirubicin + Cyclophosphamide\*4
• Препарат PCb
  Albumin Paclitaxel + Carboplatin \*6

Первичные конечные точки

• Pathologic complete response (pCR) rates [Срок оценки: Up to 180 days]

Вторичные конечные точки (7)

• Objective response rate（ORR） [Срок оценки: up to 180 days]
• Event-free survival (EFS) [Срок оценки: up to 5 years]
• Invasive Disease-Free Survival (IDFS) [Срок оценки: up to 5 years]
• Overall Survival (OS) [Срок оценки: up to 5 years]
• Adverse events [Срок оценки: up to 18 months]
• EORTC QLQ-C30 questionnaire [Срок оценки: up to 18 months]
• EORTC QLQ-BR23 questionnaire [Срок оценки: up to 18 months]

Критерии участия

Критерии включения

• Age: 18-70 years.
• Disease Status: Clinical pathological confirmation of cT2-cT4d, or cT1c with axillary lymph node metastasis.
• Pathology: Histopathologically confirmed triple-negative, invasive breast carcinoma.
• Definition of Triple-Negative Breast Cancer:
• ER and PR negative (IHC nuclear staining <10%).
• Her-2 negative (IHC 0 or 1+ without FISH, or IHC 2+ with FISH demonstrating no amplification).
• Measurable Disease: Presence of clinically measurable lesion(s) confirmed by ultrasound, mammography, or optional MRI within 1 month prior to randomization.
• Adequate Organ and Bone Marrow Function (within 1 month prior to chemotherapy), indicating no contraindications for chemotherapy:
• Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L
• Hemoglobin (Hb) ≥ 90 g/L
• Platelet count (PLT) ≥ 100 × 10⁹/L
• Total Bilirubin (TBIL) < 1.5 × ULN (Upper Limit of Normal)
• Serum Creatinine (Cr) < 1.5 × ULN
• Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) < 1.5 × ULN
• Cardiac Function: Left ventricular ejection fraction (LVEF) ≥ 50% as measured by echocardiogram.
• Pregnancy Status: For women of childbearing potential, a negative serum pregnancy test within 14 days prior to randomization.
• Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1.
• Informed Consent: Signed informed consent obtained.

Критерии исключения

• Metastatic Disease: Evidence of metastatic breast cancer. (To exclude metastasis, CT scans of the chest and abdomen, and a bone scan must be performed at any time point from diagnosis to randomization; PET/CT may serve as an alternative imaging modality).
• Prior Anti-Cancer Therapy: Any prior chemotherapy, endocrine therapy, targeted therapy, or radiotherapy for the current breast cancer.
• Second Primary Malignancy: Presence of a second primary malignancy, except for:
• Adequately treated non-melanoma skin carcinoma.
• Prior Immunotherapy: Previous treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or any other immunomodulatory therapy.
• Immunodeficiency or Autoimmune Disease: Diagnosed immunodeficiency or active autoimmune disease requiring systemic treatment.
• Severe Comorbidities: Severe or uncontrolled pulmonary or cardiac disease.
• Active Hepatitis: Active Hepatitis B or Hepatitis C infection.
• Transplantation History: History of solid organ or bone marrow transplantation.
• Pregnancy/Lactation: Pregnant or lactating women.
• Other Medical Conditions: Any other severe, uncontrolled medical condition that, in the investigator's judgment, constitutes a contraindication to chemotherapy.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07256964 · HELEN-TRIO-TORI

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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