EUCTR2016-004019-11-BG进行中（未招募）1 期
A randomised, double-blind, parallel group, equivalence, multicentre phaseIII trial to compare the efficacy, safety and pharmacokinetics of HD201 toHerceptin® in patients with HER2+ early breast cancer - TROIKA
Prestige BioPharma Pte Ltd0 个研究点目标入组 500 人开始时间: 2018年1月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
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. Able and willing to give written informed consent .
- •2. Females = 18 years of age.
- •3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) < 2.
- •4. Known hormone receptor (oestrogen receptor and progesterone
- •receptor) status.
- •5. HER2 overexpressed as assessed by
- •o Immunhistochemistry (IHC) or
- •o Fluorescent in site hybridisation (FISH); FISH positive is defined as
- •FISH amplification ratio = 2.0 / number of HER2 gene copies per cell > 2
- •o Chromogenic in situ hybridisation (CISH positive)
- •o Patients with IHC score 3+ or positive FISH/CISH test
- •o Patients with IHC score 2+ must also have a positive FISH/CISH test.
- •6. LVEF = 50% or within the normal level of the institution, as assessed
- •by echocardiography or MUGA scan.
- •7. Life expectancy > 12 weeks.
- •8.Adequate bone marrow function as evidenced by the following:
- •oAbsolute neutrophils count = 1,500/µL
- •oHaemoglobin = 9 g/dL
- •oPlatelet count = 100,000/µL
- •Up to 5% deviation is acceptable.
- •9. Adequate hepatic and renal function as evidenced by the following:
- •o Creatinine clearance = 60 mL/min
- •o Total bilirubin = 1.5 x upper limit of normal (ULN)
- •o AST (SGOT) and ALT (SGPT) = 2.5 x ULN
- •Up to 10% deviation is acceptable.
- •10. Ability to comply with the study protocol.
- •11. Female patients of childbearing potential must have a negative
- •serum pregnancy test within 7 days prior to first dose of study treatment
- •and agree to use effective contraception (intrauterine device,
- •diaphragm, diaphragm with spermicide or a reliable barrier method, e.g.
- •condom, or condom with spermicide) throughout the study period and 7
- •months after discontinuation of study drug.
- •12. Non-metastatic, unilateral, newly diagnosed, operable early breast
- •cancer (EBC) of clinical stage II and III including inflammatory breast
- •o Histologically confirmed primary invasive carcinoma of the breast
- •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 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 250
排除标准
- •1. Metastatic (stage IV) with exception of supraclavicular nodes.
- •2. Bilateral Breast Cancer
- •3. Multicentric breast cancer
- •4. History of any prior invasive breast carcinoma, except for subjects
- •with a history of ductal carcinoma in situ (DCIS) treated with surgery.
- •5. 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).
- •6. Previous history of radiation therapy, anti-neoplastic immunotherapy,
- •chemotherapy or anti-neoplastic biotherapy (including prior HER2
- •directed therapy).
- •7. Major surgery within 2 weeks prior to randomisation
- •8. Serious cardiac illness that would preclude the use of trastuzumab
- •o history of documented congestive heart failure(CHF) (New York Heart
- •Association, NYHA, class III or greater heart disease)
- •o LVEF < 50% by echocardiography or MUGA scan
- •o angina pectoris requiring anti-anginal medication
- •o evidence of transmural infarction on electrocardiogram (ECG)
- •o uncontrolled hypertension (systolic > 180 mmHg and/or diastolic > 100 mmHg)
- •o clinically significant valvular heart disease
- •o high-risk uncontrolled arrhythmias.
- •9. Serious pulmonary illness enough to cause dyspnoea at rest or
- •requiring supplementary oxygen therapy.
- •10. Known history of active hepatitis B virus (HBV) and active hepatitis C
- •virus (HCV) infection.
- •11. Known HIV infection by patient declaration.
- •12. Other severe acute or chronic medical or psychiatric condition, or
- •laboratory abnormality that may increase the risk associated with study
- •participation or study drug administration, or may interfere with the
- •interpretation of study results, and in the judgment of the investigator
- •would make the patient inappropriate for entry into this study.
- •13. Known hypersensitivity to the IMPs, non-IMPs or any of the
- •ingredients or excipients of the IMPs or non-IMPs.
- •14. Known hypersensitivity to murine proteins.
- •15. Pre-existing peripheral sensory or motor neuropathy = grade 2 (as
- •defined by NCI-CTCAE v4.03).
- •16. Lactating or pregnant woman. A pregnancy test 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 during the study and
- •for 7 months after the last dose of IMP.
- •17. Participation in any clinical study or having taken any investigational
- •therapy during the 1-month period immediately preceding
- •administration of the first dose.
- •18. Patients unwilling to follow the study requirements.
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