NCT05525767招募中4 期
Prospective, Multicenter, Single-arm Clinical Study of Chemotherapy Combined With Bevacizumab Neoadjuvant Therapy for Early or Locally Advanced HER2-negative Breast Cancer
Hebei Medical University Fourth Hospital1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2022年3月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- PCR
研究概览
简要总结
This is an prospective, multicenter, single-arm clinical study.
详细描述
Prospective, multicenter, single-arm clinical study of chemotherapy combined with bevacizumab neoadjuvant therapy for early or locally advanced HER2-negative 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old;
- •Signed the informed consent and volunteered to join the study with good compliance;
- •3, histopathologically confirmed HER2-negative invasive breast cancer (including triple-negative breast cancer; Or Luminal breast cancer, that is, ER/PR positive and HER2 negative) :
- •HER2 negative was defined as 0/1+ on standard IHC test; HER2/CEP17 ratio was less than 2.0 or HER2 gene copy number was less than
- •ER positive and/or PR positive were defined as the proportion of positively stained tumor cells in all tumor cells ≥1%;
- •4. According to the American Joint Committee on Cancer (AJCC) 8th edition TNM stage II-IIIC (T2-T4 plus any N, or any T plus N1-3, M0);
- •5. The main organs function well and meet the following standards:
- •A) Hemoglobin (HGB)≥90g/L;
- •B) Neutrophil absolute value (NEUT)≥1.5×109/L;
- •C) Platelet count (PLT)≥ 100×109/L;
- •D) leukocyte ≥3.0×109/L;
- •E) Total bilirubin <1.5 ULN (upper limit of normal)
- •F) Creatinine < 1.5×ULN
- •G) AST/ALT < 1.5×ULN;
- •6. Cardiac ultrasound: left ventricular ejection fraction (LVEF≥55%);
- •7. The investigators determined that the patients were suitable for treatment with bevacizumab.
排除标准
- •Stage IV (metastatic) breast cancer;
- •Received treatment for the disease, including chemotherapy, endocrine therapy, radiotherapy, immunotherapy, etc.;
- •Patients who are participating in other intervention studies;
- •Women with confirmed pregnancy or lactation;
- •According to the judgment of the investigator, the subjects have concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or the subjects think that there are other reasons that are not suitable for inclusion.
研究组 & 干预措施
Assigned Interventions
Experimental
Bevacizumab 10mg/Kg d1, 1/21d
干预措施: Bevacizumab (Drug)
结局指标
主要结局
PCR
时间窗: 24 months
pathologic complete response
次要结局
- ORR(24 months)
- AE Advese Event Advese Event breast conservation rates(24 months)
- BCR breast conservation rates(24 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
A Multi-Center, Single Arm Clinical Study of the Safety and Efficacy of the AURORA™ Endometrial Ablation SystemMenorrhagia Due to Benign CausesNCT02029911Minerva Surgical, Inc.63
招募中
1 期
The Safety and Efficacy of Pressurized Intraperitoneal Aerosol Chemotherapy for Peritoneal Metastatic AdenocarcinomaPeritoneal Carcinoma MetastaticNCT06743867Guangdong Provincial People's Hospital30
招募中
不适用
Anrotinib Hydrochloride Combined With Adriamycin for Neoadjuvant Treatment of High-grade Soft Tissue SarcomaSoft Tissue SarcomaNCT05747521Henan Cancer Hospital85
招募中
2 期
Prospective Clinical Study of ZPR Regimen in Elderly Treatment-naive Diffuse Large B-cell LymphomaDiffuse Large B Cell LymphomaNCT05940064Peng Liu30
招募中
2 期
Prospective Clinical Study of ZPR Regimen in Relapsed/Refractory Diffuse Large B-cell LymphomaDiffuse Large B Cell LymphomaNCT05940051Peng Liu35