NCT07256964尚未招募2 期
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
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 216
- 主要终点
- Pathologic complete response (pCR) rates
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≤
- •Informed Consent: Signed informed consent obtained.
排除标准
- •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.
研究组 & 干预措施
PCb-EC+PD1
Active Comparator
干预措施: Toripalimab (Drug)
PCb-EC+PD1
Active Comparator
干预措施: PCb-EC (Drug)
PCb+PD1
Experimental
干预措施: Toripalimab (Drug)
PCb+PD1
Experimental
干预措施: PCb (Drug)
结局指标
主要结局
Pathologic complete response (pCR) rates
时间窗: Up to 180 days
次要结局
- Objective response rate（ORR）(up to 180 days)
- Event-free survival (EFS)(up to 5 years)
- Overall Survival (OS)(up to 5 years)
- Invasive Disease-Free Survival (IDFS)(up to 5 years)
- Adverse events(up to 18 months)
- EORTC QLQ-C30 questionnaire(up to 18 months)
- EORTC QLQ-BR23 questionnaire(up to 18 months)
研究者
Zhenzhen Liu
Professor
Henan Cancer Hospital
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