A Double-Blind, Randomized Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Biocad
- 入组人数
- 398
- 试验地点
- 3
- 主要终点
- To compare the efficacy of BCD-178 and Perjeta as neoadjuvant therapy by studying the total pathological complete response (tpCR) rate
研究概览
简要总结
The goal of this study is to compare the efficacy and safety of BCD-178 and Perjeta as neoadjuvant therapy for HER2-positive breast cancer.
Subjects with histologically confirmed diagnosis of HER2-positive invasive breast cancer (stage II-III, tumor size > 2 cm), with no estrogen (ER) and progesterone (PR) receptors will be randomized to one of two treatment groups (BCD-178 group or Perjeta group) in a 1:1 ratio.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent ;
- •Histologically confirmed diagnosis of invasive breast cancer;
- •Disease stage cT2-cT4, cN0-cN3, cM0;
- •Positive HER2 expression, negative estrogen and progesterone receptor expression;
- •ECOG score 0-1;
- •Adequate organ function;
- •Baseline LVEF ≥ 55%, as measured with the standard procedure;
- •Consent of women of childbearing potential to use highly effective methods of contraception, starting from the signing of the informed consent form, throughout the study and for 6 months after receiving the last dose of the product.
排除标准
- •Stage IV (metastatic) breast cancer;
- •A history of any systemic therapy for breast cancer;
- •Concomitant diseases and/or conditions that significantly increase the risk of adverse events during the study;
- •Pregnancy or breastfeeding, as well as pregnancy planning throughout the study and for 6 months after receiving the last dose of the product;
- •Hypersensitivity or allergy to any of the components of BCD-178, Perjeta, trastuzumab, carboplatin, and docetaxel.
研究组 & 干预措施
BCD-178 group
Neoadjuvant therapy stage (6 cycles, 18 weeks): BCD-178, Trastuzumab, Docetaxel, Carboplatin; Surgical treatment; Adjuvant therapy stage (up to 12 months of HER2-targeted therapy in total): BCD-178, Trastuzumab
干预措施: BCD-178 (Drug)
Perjeta Group
Neoadjuvant therapy stage (6 cycles, 18 weeks): Perjeta, Trastuzumab, Docetaxel, Carboplatin; Surgical treatment; Adjuvant therapy stage (up to 12 months of HER2-targeted therapy in total): BCD-178, Trastuzumab
干预措施: Perjeta (Drug)
结局指标
主要结局
To compare the efficacy of BCD-178 and Perjeta as neoadjuvant therapy by studying the total pathological complete response (tpCR) rate
时间窗: immediately after the surgery
Proportion of subjects achieving tpCR
次要结局
- breast pathological complete response (bpCR) rate(immediately after the surgery)
- overall response rate (ORR)(at Week 18)
- breast-conserving surgery rate(immediately after surgery)
- safety assessment(up to 65 weeks)
- immunogenicity assessment(pre-dose to week 52, 5 timepoints)
- Pharmacokinetics assessment(pre-dose to week 18, 12 timepoints)