A Phase II Study of Camrelizumab, Fluzoparib and Nab-paclitaxel in Neoadjuvant Therapy of Her-2 Negative Breast Cancer Patients With HRR Gene Mutation
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Pathologic Complete Response (pCR)
研究概览
简要总结
This study is to evaluate the efficacy and safety of combination of Camrelizumab (Immunotherapy, PD-1 inhibitor), Fluzoparib (PARP inhibitor) and Nab-paclitaxel in neoadjuvant therapy of Her-2 negative breast cancer patients with HRR gene mutation.
详细描述
This is a prospective, single-center, open-label phase II clinical trial investigating the activity of Camrelizumab+Fluzoparib+Nab-paclitaxel combination therapy in breast cancer patients with Her2-negative and HRR gene mutation for neoadjuvant therapy.
Anticipated 66 candidates meeting all study eligibility criteria will receive 8 cycles of Nab-paclitaxel (260mg/m2) every 3 weeks, which will add Camrelizumab (200mg, d1) and Fluzoparib (100mg BID) from the second cycle.
HRR gene mutation contains at least one pathogenic or likely pathogenic variant in germline or somatic BRCA1, BCRA2 and PALB2 genes, or in germline ATM, BARD1, BRIP1, CDK12, CHEK2, RAD51C, RAD51D genes.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically documented Her-2 negative
- •TNM stage: T1c, N1-N2；T2-4, N0-N2；any T, N3
- •No distant metastatic disease
- •Eastern Cooperative Oncology Group Performance Status: 0~1
- •HRR gene mutation: at least one pathogenic or likely pathogenic variant in germline or somatic BRCA1, BCRA2 and PALB2 genes, or in germline ATM, BARD1, BRIP1, CDK12, CHEK2, RAD51C, RAD51D genes.
排除标准
- •Patients who are pregnant or lactating at the time of randomization or refuse to contraception.
- •Patients who have other malignant diseases within 2 years, except for cured skin basal cell carcinoma, breast carcinoma in situ or cervical carcinoma in situ
- •Patients with psychiatric disorder, peripheral or central nerve system disease or any disorder, which compromises ability to give informed consent or participate in this study.
- •Patients who have myocardial infarction or congestive heart failure, or other serious cardiac disease.
- •Patients who have used immunosuppressive drug or corticosteroids within 14 days.
- •Patients who have other diseases which researchers.
- •Patients who allergy to any of the drugs in this trail.
研究组 & 干预措施
Camrelizumab, Fluzoparib and Nab-paclitaxel
Participants who confirmed pathogenic or likely pathogenic HRR gene mutation received Camrelizumab and Fluzoparib with nab-paclitaxel from the second cycle followed by nab-paclitaxel for one cycle.
干预措施: Camrelizumab (Drug)
Camrelizumab, Fluzoparib and Nab-paclitaxel
Participants who confirmed pathogenic or likely pathogenic HRR gene mutation received Camrelizumab and Fluzoparib with nab-paclitaxel from the second cycle followed by nab-paclitaxel for one cycle.
干预措施: Fluzoparib (Drug)
Camrelizumab, Fluzoparib and Nab-paclitaxel
Participants who confirmed pathogenic or likely pathogenic HRR gene mutation received Camrelizumab and Fluzoparib with nab-paclitaxel from the second cycle followed by nab-paclitaxel for one cycle.
干预措施: Nab-paclitaxel (Drug)
结局指标
主要结局
Pathologic Complete Response (pCR)
时间窗: Up to 32 weeks
Pathologic response will be assessed in the surgically resected cancer and lymph nodes after completion of all chemotherapy by the local pathologist as part of routine care. Pathologic complete response is defined as no invasive cancer in the resected breast tissue and lymph nodes (ypT0/Tis, ypN0).
次要结局
- Overall Survival (OS)(Up to 20 years)
- Event-Free Survival (EFS)(Up to 20 years)
- Objective Response Rate (ORR)(Up to 32 weeks)
- Safety of drugs(Up to 32 weeks)
- Residual Cancer Burden (RCB)(Up to 32 weeks)
研究者
Ying Lin
director of department
First Affiliated Hospital, Sun Yat-Sen University