A Randomized, Multicenter, Double-Blind, Parallel-Controlled, Phase III Clinical Study to Evaluate QL1209/Pertuzumab in Combination With Docetaxel in Patients With Early-Stage or Locally Advanced HER2-Positive and ER/PR-negative Breast Cancer.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 517
- 试验地点
- 2
- 主要终点
- Total pathologic complete response (tpCR) rate
研究概览
简要总结
This is a randomized, double-blind, multicenter trial，parallel control designed to evaluate treatment with trastuzumab + QL1209 + docetaxel compared with trastuzumab + pertuzumab + docetaxel in the participants with early-stage or locally advanced HER2-positive and estrogen receptor/progesterone receptor negative breast cancer. The anticipated treatment duration is approximately 140 days.
详细描述
This is A multi-center, randomized, double-blind, parallel control，comparative clinical trial.
The primary objective is to evaluate whether the clinical efficacy of QL1209 and pertuzumab are similar in patients with early-stage or locally advanced HER2-positive and estrogen receptor/progesterone receptor negative breast cancer.
The secondary objective are to evaluate whether the clinical safety and immunogenicity of QL1209 and pertuzumab are similar in patients with early-stage or locally advanced HER2-positive and estrogen receptor/progesterone receptor negative breast cancer.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteer to participate in this clinical study; Completely understand and know this study as well as sign the informed consent form (ICF);
- •Age ≥ 18 years and ≤ 80 years when ICF is signed;
- •Histologically confirmed invasive breast carcinoma with a primary tumor size of more than (>) 2 centimeters (cm) by standard local assessment technique; Breast cancer stage at presentation: early-stage (T2-3, N0-1, M0) or locally advanced (T2-3, N2 or N3, M0; T4, any N, M0); HER2-positive breast cancer confirmed by immunohistochemistry or HER2 gene amplification by in situ hybridization; Estrogen receptor and Progesterone receptor negative.
- •Eastern Cooperative Oncology Group Performance Status equal to or less than (<=)
- •Baseline left ventricular ejection fracture >= 55% measured by echocardiography (preferred) or multiple gated acquisition scan
排除标准
- •Stage IV metastatic breast cancer;
- •Inflammatory breast cancer;
- •Previous anti-cancer therapy or radiotherapy for any malignancy;
- •History of malignancies other than colorectal cancer within 5 years prior to randomization, excluding cutaneous basal cell carcinoma, cervical carcinoma in situ, and thyroid papillary adenocarcinoma of non-melanoma after radical treatment;
- •Concurrent anti-cancer treatment in another investigational trial, including hormone therapy, bisphosphonate therapy, or immunotherapy;
- •Major surgical procedure within 4 weeks prior to randomization or from which the participant has not fully recovered;
- •Serious cardiac illness or medical condition;
- •Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness;
- •Sensitivity to any of the study medications, any of the ingredients or excipients of these medications, or benzyl alcohol;
- •Pregnant or lactating
研究组 & 干预措施
Trastuzumab Plus（+） QL1209 + Docetaxel
Prior to surgery: trastuzumab, QL1209, and docetaxel for 4 cycles (1 cycle = 21 days) Drug: Docetaxel Drug: QL1209 Drug: Trastuzumab Procedure: Surgery
干预措施: Trastuzumab (Drug)
Trastuzumab Plus（+） QL1209 + Docetaxel
Prior to surgery: trastuzumab, QL1209, and docetaxel for 4 cycles (1 cycle = 21 days) Drug: Docetaxel Drug: QL1209 Drug: Trastuzumab Procedure: Surgery
干预措施: QL1209 (Drug)
Trastuzumab Plus（+） QL1209 + Docetaxel
Prior to surgery: trastuzumab, QL1209, and docetaxel for 4 cycles (1 cycle = 21 days) Drug: Docetaxel Drug: QL1209 Drug: Trastuzumab Procedure: Surgery
干预措施: Docetaxel (Drug)
Trastuzumab Plus（+） QL1209 + Docetaxel
Prior to surgery: trastuzumab, QL1209, and docetaxel for 4 cycles (1 cycle = 21 days) Drug: Docetaxel Drug: QL1209 Drug: Trastuzumab Procedure: Surgery
干预措施: surgery (Procedure)
Trastuzumab Plus（+） Pertuzumab + Docetaxel
Prior to surgery: trastuzumab,pertuzumab , and docetaxel for 4 cycles (1 cycle = 21 days) Drug: Docetaxel Drug: Pertuzumab Drug: Trastuzumab Procedure: Surgery
干预措施: Trastuzumab (Drug)
Trastuzumab Plus（+） Pertuzumab + Docetaxel
Prior to surgery: trastuzumab,pertuzumab , and docetaxel for 4 cycles (1 cycle = 21 days) Drug: Docetaxel Drug: Pertuzumab Drug: Trastuzumab Procedure: Surgery
干预措施: Pertuzumab (Drug)
Trastuzumab Plus（+） Pertuzumab + Docetaxel
Prior to surgery: trastuzumab,pertuzumab , and docetaxel for 4 cycles (1 cycle = 21 days) Drug: Docetaxel Drug: Pertuzumab Drug: Trastuzumab Procedure: Surgery
干预措施: Docetaxel (Drug)
Trastuzumab Plus（+） Pertuzumab + Docetaxel
Prior to surgery: trastuzumab,pertuzumab , and docetaxel for 4 cycles (1 cycle = 21 days) Drug: Docetaxel Drug: Pertuzumab Drug: Trastuzumab Procedure: Surgery
干预措施: surgery (Procedure)
结局指标
主要结局
Total pathologic complete response (tpCR) rate
时间窗: Approximately 26 months after randomization of the first patient, when all patients have completed the treatment completion/discontinuation visit
Total pathologic complete response (tpCR) rate, defined as ypT0/is, ypN0 as assessed by an Independent Review Committee (IRC)
次要结局
- Percentage of Participants With Breast Pathologic Complete Response (bpCR) assessed by the IRC(Approximately 26 months after randomization of the first patient, when all patients have completed the treatment completion/discontinuation visit)
- Percentage of Participants With bpCR as Assessed by the Local Pathologist(At surgery)
- Percentage of Participants With an Objective Response(Before surgery)
- Percentage of Participants With tpCR as Assessed by the Local Pathologist(At surgery)