NCT04760431尚未招募2 期
Anti-HER2 TKI Versus Pertuzumab in Combination With Dose-dense Trastuzumab and Taxane as First Line in HER2-positive Breast Cancer Patients With Active Brain Metastases: A Phase II, Multicenter, Double-blind, Randomized Clinical Trial
Second Affiliated Hospital, School of Medicine, Zhejiang University3 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This is a prospective, randomized, 2-arm, Phrase 2, superiority and multicenter study to compare the efficiency of Anti-HER2 TKI versus Pertuzumab in Combination With Dose-dense Trastuzumab and Taxane in HER2-positive breast cancer patients with active refractory brain metastases.
详细描述
This is a prospective, randomized, 2-arm, Phrase 2, superiority and multicenter study. HER2-positive breast cancer patients with active refractory brain metastases are included. There will be two group: Group A (Trastuzumab, Taxanes and Pertuzumab) and Group B (Trastuzumab, Taxanes and TKIs). The primary outcome is objective response rate (ORR).
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
- Double (Participant, Investigator)
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
- •Patients provided written informed consent
- •Women aged 18-75 years
- •Histologically or cytologically confirmed HER2-positive (IHC 3+ or ISH+) breast cancer
- •Patients of HER2 positive breast cancer with a documented central nervous system (CNS) recurrence/progression (by imaging) during or after Trastuzumab based therapy
- •At least one measurable and progressive lesion in the CNS (≥10 mm on T1-weighted, gadolinium-enhanced MRI)
- •Previous treatment with HER2 inhibitors to be discontinued prior to first study treatment administration (at least 14 days for trastuzumab and other antibodies, at least 7 days for lapatinib)
- •Previous chemotherapy and hormonal therapy (adjuvant and metastatic regimens) allowed, but chemotherapy must have been discontinued at least 14 days and hormonal therapy at least 7 days prior to first study treatment administration
- •Prior surgery, whole brain radiotherapy or stereotactic radiosurgery allowed provided that there is unequivocal evidence of one or more new and/or progressive brain metastases after completion of whole brain radiotherapy or stereotactic radiosurgery
- •Previous radiotherapy allowed, but radiotherapy must have been discontinued at least 14 days prior to first study treatment administration
- •Normal cardiac function
- •Patients must have recovered to baseline condition or to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade = 1 from any acute CTCAE v. 5.0 grade =2 side effects of previous treatments
- •Without infection of human immunodeficiency virus (HIV) on central laboratory assay results prior to randomization
- •Alanine aminotransferase (ALT) </= 2.5 × the upper limit of normal (ULN), Aspartate aminotransferase (AST) </= 2.5 × ULN prior to randomization
- •Total bilirubin (TBIL) </= 1.25 × ULN
- •Alkaline phosphatase (ALK) </= 2.5 × ULN
- •Gamma glutamyl transpeptidase (GGT) </= 2.5 × ULN
- •Albumin >/= 30g/L
- •Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1
- •A life expectancy of at least 1 month
- •Women of child-bearing age should take effective contraceptive measures
- •Serum total bilirubin (TBil) </= 1.5 × ULN
- •Serum creatinine (Scr) </= 1.5 × ULN
- •WBC >/= 3×109/L, Blood neutrophil count >/= 1×109/L, Platelet count >/= 100×109/L, HB >/= 9 g/dL
排除标准
- •Lack of histological or cytological confirmation of HER2-positive (IHC 3+ or ISH-positive) breast cancer
- •Cerebral hernia
- •Need radiotherapy or surgery immediately
- •Active cerebral infarction or hemorrhage
- •Only meningeal metastasis
- •Earlier exposure to doxorubicin or pirarubicin at a dosage of more than 360 mg/m2
- •Earlier exposure to epirubicin at a dosage of more than 900 mg/m2
- •Prior treatment with HER2-tyrosine kinase inhibitors
- •Treatment with trastuzumab emtansine within 6 months
- •Any other current malignancy or malignancy diagnosed within the past five years (other than carcinoma in situ or stage Ia carcinoma of the cervix, skin basal cell carcinoma and papillary thyroid carcinoma at early stage)
- •Active infection with human immunodeficiency virus (HIV) prior to first study treatment administration.
- •History of participating any other clinical trials within 30 days prior to randomization
- •Known hypersensitivity (Grade 3 or 4) to any of the trial drugs
- •Pregnancy or lactation
- •Current severe systemic disease (for example, clinically significant cardiovascular, pulmonary, or renal disease)
- •Legal incompetence or limitation.
- •Considered unable to complete the study or sign the informed consent due to a medical or mental disorder by the investigator.
研究组 & 干预措施
Group A
Active Comparator
Trastuzumab, Taxanes and Pertuzumab
干预措施: Trastuzumab (Drug)
Group A
Active Comparator
Trastuzumab, Taxanes and Pertuzumab
干预措施: Taxanes (Drug)
Group A
Active Comparator
Trastuzumab, Taxanes and Pertuzumab
干预措施: Pertuzumab (Drug)
Group B
Experimental
Trastuzumab, Taxanes and TKIs
干预措施: Trastuzumab (Drug)
Group B
Experimental
Trastuzumab, Taxanes and TKIs
干预措施: Taxanes (Drug)
Group B
Experimental
Trastuzumab, Taxanes and TKIs
干预措施: Tyrosine kinase inhibitor (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: up to 3 years
The sum of complete response (CR) rate and partial response (PR) rate by measurement of target lesions (intracranial lesions)
次要结局
- Overall Survival (OS)(up to 3 years)
- Objective Response Rate 2 (ORR2)(up to 3 years)
- Progression-free Survival (PFS)(up to 3 years)
- Disease control rate (DCR)(up to 3 years)
- Clinical benefit rate (CBR)(up to 3 years)
- Peripheral neurotoxicity(30 days after last treatment)
研究者
研究点 (3)
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