NCT05576389招募中2 期
Fluzoparib Combined With Camrelizumab for Neoadjuvant Treatment of Embryogenic BRCA Mutation HER2 Negative Breast Cancer: an Open, Single Arm, Multicenter Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- tpCR（ypT0/is ypN0）
研究概览
简要总结
This study is an open-label, single-arm, multicenter clinical study. 64 patients with germline BRCA-mutated HER2-negative early breast cancer are planned to be enrolled and treated with fluzoparib combined with camrelizumab to observe and evaluate the efficacy and safety of neoadjuvant fluzoparib combined with camrelizumab in the treatment of germline BRCA-mutated HER2-negative early breast cancer。
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •According to the definition of the latest ASCO/CAP guidelines, early or locally advanced HER2 negative invasive breast cancer confirmed by histopathology meets the following conditions:
- •HER2 negative: IHC 0/1+or IHC2+with no amplification of ISH;
- •Primary tumor size: ≥ 1cm
- •Lymph node status: N0-3
- •Inflammatory breast cancer patients with measurable lesions (according to RECIST 1.1 standard)
- •Patients with bilateral breast cancer whose primary lesions all meet the inclusion criteria, or breast cancer with Tis-1bN0 and HER2 negative on the other side only meeting the inclusion criteria on one side;
- •The hormone receptor status is known;
- •ECOG score 0-1;
- •Carrying BRCA1 or BRCA2 germline pathogenic mutations or suspected pathogenic mutations;
- •According to RECIST 1.1 standard, at least one measurable lesion is present;
排除标准
- •Tumor related symptoms and treatment
- •Recurrent or metastatic breast cancer;
- •Participated in other drug trials or received any anti-tumor therapy, including endocrine therapy, bisphosphate therapy, immunotherapy, biological therapy, or tumor embolization, within 4 weeks prior to enrollment;
- •Previously received treatment for PD-1/PD-L1 antibodies, CTLA-4 antibodies, or other PD-1/PD-L1 inhibitors;
- •Previously received PARP inhibitor treatment (excluding those who have completed PARP inhibitor treatment for ovarian cancer for at least 5 years without recurrence or metastasis);
- •Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis or combined hepatitis B and C co-infection; autoimmune hepatitis;
- •Confirmed history of heart failure or systolic dysfunction (LVEF < 50%); high risk uncontrolled cardiac arrhythmias, such as atrial tachycardia; angina requiring antianginal medication
- •Female patients who are pregnant or lactating
- •History of definite neurological or psychiatric disorders, including epilepsy or dementia
- •Presence of interstitial lung disease, pneumonitis, or uncontrolled systemic disease (eg, diabetes mellitus, pulmonary fibrosis, acute pneumonitis, etc.)
研究组 & 干预措施
Camrelizumab+Fluzoparib
Experimental
Fluzoparib combined with Carolizumab for 8 cycles of neoadjuvant therapy. Allowing the continued use of combination therapy or monotherapy with Carolizumab and fluzoparib during the adjuvant therapy phase, with an overall treatment duration not exceeding 12 months.
干预措施: Camrelizumab+Fluzoparib (Drug)
结局指标
主要结局
tpCR（ypT0/is ypN0）
时间窗: 6 months
total pathological complete response
次要结局
未报告次要终点
研究者
Shu Wang
Chief Physician
Peking University People's Hospital
研究点 (1)
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