NCT06001086招募中2 期
A Multicenter, Open Phase II Clinical Study to Evaluate the Efficacy and Safety of Disitamb Vedotin Combined With Pyrotinib in Previously Untreated Histologically Proven HER2 Positive Early Breast Cancer
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- pathologic complete response（pCR）
研究概览
简要总结
Evaluate the efficacy and safety of Disitamb Vedotin combined with pyrotinib in HER2 positive early breast cancer
详细描述
The main goal of this clinical trial is to evaluate the efficacy of Disitamb Vedotin combined with pyrotinib in previously untreated histologically proven HER2 positive early breast cancer and evaluate the PCR DFS,OS and safety of the subjects.
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
- •1.18 to 75 years old (at the time of signing the informed consent form), regardless of gender.
- •Subject type and disease characteristics. Histologically confirmed HER2 positive EBC subjects:
- •evaluated as HER2 positive in local laboratories according to ASCOCAP guidelines.
- •Single and multifocal tumors (greater than 1 tumor area limited to the same quadrant as the primary tumor) must be sampled from 1 lesion and laboratory confirmed as HER2 positive.
- •Multicenter tumors (multiple tumors involving more than one breast quadrant) must sample one lesion from each affected quadrant and be confirmed as HER2 positive by the central laboratory.
- •According to ASCOCAP guidelines, tumors are either HR positive or HR negative (ER and PgR negative).
- •Clinical staging at visit (based on breast X-ray or breast MRI evaluation): Stage II-IIIC determined by the AJCC staging system, 8th edition. (f) Lymph node involvement is determined by fine needle aspiration or coarse needle aspiration biopsy (if applicable).
- •When randomized, ECOG physical fitness status is 0 or 1 point.
排除标准
- •Previous history of invasive breast cancer.
- •Stage IV breast cancer according to AJCC staging system version
- •Within 3 years, there is any primary malignant tumor, except for fully resected non-melanoma skin cancer or cured in situ disease.
- •DCIS medical history, except for the subjects who only received Mastectomy
- •According to the judgment of the researchers, there is evidence of any diseases (such as severe or uncontrolled systemic diseases, including persistent or active infections, uncontrolled hypertension, kidney transplantation and active bleeding diseases, and severe chronic gastrointestinal diseases related to diarrhea) that the researchers consider to be unfavorable for the participants to participate in the study or may affect adherence to the protocol.
- •Uncontrolled infection requiring intravenous administration of antibiotics, Antiviral drug or antifungal drugs.
研究组 & 干预措施
Disitamb Vedotin combined with pyrotinib
Experimental
Disitamb Vedotin: 2 mg/kg，ivgtt，d1,14/28day/cycle pyrotinib:320mg, oral, every day.
干预措施: Disitamb Vedotin ,pyrotinib (Drug)
结局指标
主要结局
pathologic complete response（pCR）
时间窗: 1 year
The pCR rate is defined as the proportion of subjects who, after completion of neoadjuvant therapy, showed no evidence of residual invasive lesions in H\&E staining in completely excised breast specimens and all sampled local lymph nodes (ypT0/TisypN0) through central evaluation
次要结局
- Disease free survival （DFS)(3 years)
- Overall Survival（OS）(5year)
- Patient Report Outcome（PRO）(3years)
- The Number of Participants Who Experienced Adverse Events (AE)(1 year)
研究者
研究点 (1)
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