NCT02149524已完成3 期
A Phase III Randomised, Double-Blind, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity Between SB3 (Proposed Trastuzumab Biosimilar) and Herceptin® in Women With Newly Diagnosed HER2 Positive Early or Locally Advanced Breast Cancer in Neoadjuvant Setting
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 875
- 试验地点
- 1
- 主要终点
- The Pathologic Complete Response (pCR) Rate of the Primary Breast Tumour
研究概览
简要总结
A Phase III Randomised, Double-Blind, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity between SB3 (proposed trastuzumab biosimilar) and Herceptin® in Women with Newly Diagnosed HER2 Positive Early or Locally Advanced Breast Cancer in Neoadjuvant Setting
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged 18-65 years
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Non-metastatic, unilateral newly diagnosed primary breast cancer of clinical stage II to III including inflammatory breast cancer with:
- •tumour size ≥ 2 cm
- •histologically confirmed primary invasive carcinoma of the breast
- •HER2-positivity confirmed by a central laboratory or an accredited local laboratory and defined as immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH)+
- •Known hormone receptor (oestrogen receptor and progesterone receptor) status
- •Baseline left ventricular ejection fraction (LVEF) ≥ 55% measured by echocardiography or multiple gated acquisition (MUGA) scan
- •Subjects must be able to provide informed consent, which must be obtained prior to any study related procedures
排除标准
- •Metastatic (stage IV) or bilateral or multifocal/multicentric breast cancer
- •History of any prior invasive breast carcinoma, except for subjects with a past history of ductal carcinoma in situ (DCIS) and/or lobular carcinoma in situ (LCIS) treated with surgery only
- •Past or current history of malignant neoplasms within 5 years prior to Randomisation, except for curatively treated carcinoma in situ of uterine cervix, basal cell carcinoma of the skin or squamous cell carcinoma of the skin (malignant neoplasms occurring more than 5 years prior to Randomisation are permitted if curatively treated with surgery only)
- •Previous history of radiation therapy, immunotherapy, chemotherapy or biotherapy (including prior HER2 directed therapy) Major surgery within 4 weeks prior to Randomisation and minor surgery within 2 weeks prior to Randomisation (major surgery is defined as surgery which requires general anaesthesia)
- •Serious cardiac illness that would preclude the use of trastuzumab such as:
- •history of documented congestive heart failure (CHF) (New York Heart Association, NYHA, class II or greater heart disease)
- •LVEF < 55% by echocardiography or MUGA scan
- •angina pectoris requiring anti-anginal medication
- •evidence of transmural infarction on electrocardiogram (ECG)
- •uncontrolled hypertension (systolic > 180 mmHg and/or diastolic > 100 mmHg)
- •clinically significant valvular heart disease
- •high risk uncontrolled arrhythmias
- •Serious pulmonary illness enough to cause dyspnoea at rest or requiring supplementary oxygen therapy
- •Known history of hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection
- •Other concurrent serious illnesses that may interfere with planned therapy including severe cardiovascular, pulmonary, metabolic or infectious conditions
- •Known hypersensitivity to the investigational product (IPs), non-IPs or any of the ingredients or excipients of the IPs or non-IPs
- •Known hypersensitivity to murine proteins
- •Known history of dihydropyrimidine dehydrogenase (DPD) deficiency
- •Pre-existing peripheral sensory or motor neuropathy ≥ grade 2, defined by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0
- •Pregnant or lactating women. A pregnancy test result is required for all women of childbearing potential including women who had menopause onset within 2 years prior to Randomisation. Women of childbearing potential must agree to use contraceptive methods (see section 7.4.2) during the study and 6 months after the last dose of IP
- •Concurrent hormonal therapy including birth control pills, ovarian hormone replacement for menopause, selective oestrogen receptor modulator (SERM) either for osteoporosis or breast cancer prevention
- •Subjects unwilling to follow the study requirements
研究组 & 干预措施
Herceptin (trastuzumab)
Active Comparator
Intravenous administration
干预措施: Herceptin (trastuzuamb) (Drug)
SB3 (proposed trastuzumab biosimilar)
Experimental
Intravenous administration
干预措施: SB3 (proposed trastuzumab biosimilar) (Drug)
结局指标
主要结局
The Pathologic Complete Response (pCR) Rate of the Primary Breast Tumour
时间窗: Week 24
次要结局
- Overall Clinical Response Rate (ORR)(Week 24)
- Total Pathological Complete Response (tpCR) Rate(Week 24)
- Event-free Survival (EFS)(1 month after last dose of investigational product)
- Overall Survival (OS)(1 month after the last administration of investigational product)
研究者
研究点 (1)
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