EUCTR2013-004172-35-BG进行中（未招募）1 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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 806
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Female aged 18-65 years
- •2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •3. Non-metastatic, unilateral newly diagnosed primary breast cancer of clinical stage II to III including inflammatory breast cancer with:
- •a. tumour size = 2 cm
- •b. histologically confirmed primary invasive adenocarcinoma of the
- •c. HER2-positivity confirmed by a central laboratory or an accredited local laboratory and defined as immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH) +:
- •4. Known hormone receptor (oestrogen receptor and progesterone receptor) status
- •5. Baseline LVEF = 55% measured by echocardiography or mmultiple gated acquisition (MUGA) scan
- •6. Subjects must be able to provide informed consent, which must be obtained prior to any study related procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 498
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Metastatic (stage IV) or bilateral or clinically detectable two separate
- •breast cancer masses by physical examination (palpation).
- •2. 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.
- •3. 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 neoplasm occurring more than 5 years prior to Randomisation are permitted if curatively treated with surgery only)
- •4. Previous history of radiation therapy (RT), immunotherapy, chemotherapy or biotherapy (including prior HER2 directed therapy)
- •5. 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); the diagnostic
- •procedures such as open and/or core-needle biopsies will not be
- •regarded as surgeries mentioned above; SLNB before initiation of
- •neoadjuvant therapy will be exempted from this criterion)
- •6. Serious cardiac illness that would preclude the use of trastuzumab such as:
- •a. history of documented CHF (NYHA class II or greater heart disease)
- •b. LVEF < 55% by echocardiography or MUGA scan
- •c. angina pectoris requiring anti-anginal medication
- •d. evidence of transmural infarction on Electrocardiogram (ECG)
- •e. uncontrolled hypertension (systolic > 180 mmHg and/or diastolic > 100 mmHg)
- •f. clinically significant valvular heart disease
- •g. high risk uncontrolled arrhythmias
- •7. Serious pulmonary illness enough to cause dyspnoea at rest or requiring supplementary oxygen therapy
- •8. Known history of HBV (excluding immunized or fully recovered from
- •the past infection), HCV or HIV infection
- •9. Other concurrent serious illnesses that may interfere with planned treatment including severe cardiovascular, pulmonary, metabolic or infectious conditions
- •10. Known hypersensitivity to the IPs, non-IPs or any ingredients or excipients of the IPs or non-IPs
- •11. Known hypersensitivity to murine proteins
- •12. Known history of dihydropyrimidine dehydrogenase (DPD) deficiency
- •13. Pre-existing peripheral sensory or motor neuropathy = grade 2, defined by NCI-CTCAE v4.0
- •14. Any of the following abnormal laboratory tests
- •a. serum total bilirubin > 1.5 × upper limit of normal (ULN); in cases of known Gilberts syndrome, level of total bilirubin within 3 × ULN is permitted
- •b. aspartate transaminase (AST) and/or alanine transaminase (ALT) > 1.5 × ULN
- •c. alkaline phosphatase (ALP) > 2.5 × ULN
- •d. serum creatinine > 1.5 × ULN
- •e. haemoglobin (Hb) < 9 g/dL
- •f. absolute neutrophil count (ANC) < 1500/mm3 (< 1.5 × 109/L)
- •g. platelets count < 100000/mm3 (< 100 × 109/L)
- •15. 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 non-hormonal contraceptive methods (see section 7.4.2.) during the study and 7 months after the last dose IP
- •16. Concurrent hormonal therapy including birth control pills, ovarian hormone replacement for menopause, selective oestrogen receptor modulator (SERM) either for osteoporosis or breast cancer prevention
- •17. Subjects unwilling to follow the study requirements
研究者
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