CTRI/2013/04/003549进行中（未招募）3 期
Prospective, multi-centre, randomized, open-label, twoarm,parallel group, active-control, comparative clinicalstudy to evaluate efficacy, safety and pharmacokineticsof R-TPR-016/ Herceptin® when given intravenously inpatients with Metastatic HER2-Overexpressing BreastCancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 105
- 试验地点
- 20
- 主要终点
- Efficacy will be assessed as Objective Response Rate (Complete Response and Partial Response) by RECIST 1.1 criteria at 25 weeks
研究概览
简要总结
This is a prospective, multi-centre, open-label, two-arm, parallel group, active-control, randomized comparative clinical study. The study will evaluate the efficacy safety and pharmacokinetics of R-TPR-016 and Herceptin® in patients with Metastatic HER2-Overexpressing Breast Cancer.
The primary outcome measures was to assess the efficacy as overall response rate (Complete Response and Partial Response) assessed by RECIST 1.1 criteria at 25 weeks. 105 subject were recruited from 20 sites in India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Histologically or cytologically confirmed adenocarcinoma of the breast with locally advanced or metastatic disease that is HER2 positive as confirmed by positive fluorescence in situ hybridization (FISH) or by immunohistochemistry 3+ score.
- •Patients who have received adjuvant therapy and/or completed no more than 1 regimen of chemotherapy for metastatic disease.
- •Any previous chemotherapy exposure should have been completed >3 weeks before randomization into the present study.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (specifically, ascites, pleural, or pericardial effusions, osteoblastic bone metastases, or carcinomatous lymphangitis of the lung cannot be the only lesion)
- •Normal laboratory tests including ANC ≥1.5x109/L, Platelets ≥100x109/L, Hemoglobin>9.0 g/dL, Serum Creatinine ≤ 1.5 ULN and Total bilirubin ≤ 1.5 mg/dL.
- •Subjects with baseline cardiac ejection fraction ≥ 50% by echocardiography (ECHO) or Multiple Gate Acquisition (MUGA) scan.
- •Estimated life expectancy >6 months
- •Able to understand the study procedures, the risks involved, willing to provide written Informed Consent, and able to adhere to study schedules and requirements.
排除标准
- •Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease, wound healing disorders, ulcers or bone fractures)
- •Patients with history of radiation within 4 weeks before the first cycle of chemotherapy in the study or planning radiation during the first 3 cycles of the study.
- •Previous bone marrow or stem-cell transplantation
- •Diagnosis of concurrent second malignancy or leukemia, myeloid aplasia, aplastic anemia, sickle cell disease and/or lymphoma with marrow involvement and/or known brain metastases
- •History of chemotherapy causing delayed myelosuppression (nitrosureas, mitomycin C, etc.)
- •History of trastuzumab administration ≤ 21 days prior to randomization.
- •Current clinical or radiographic evidence of central nervous system (CNS) metastases.
- •History of exposure to the following cumulative doses of anthracyclines: Doxorubicin or liposomal doxorubicin 500 mg/m2; Epirubicin 900 mg/m2; Mitoxantrone 120mg/m2 and idarubicin 90 mg/m2
- •Major surgical procedure or significant traumatic injury within approximately 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment
- •History of intolerance (including Grade 3-4 infusion reaction) or hypersensitivity to trastuzumab, murine proteins or paclitaxel
- •Serious inter-current chronic or acute illness such as pulmonary (asthma or COPD) or cardiac (NYHA class III or IV) or hepatic disease or other illness considered by the Principal Investigator to constitute an unwarranted high risk for investigational drug treatment
- •Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.
- •Cardiac disease that would preclude the use of doxorubicin, docetaxel and trastuzumab: o Any documented myocardial Infarction o Angina pectoris that requires the use of anti-angina medication o Any history of documented congestive heart failure o Grade 3 or Grade 4 cardiac arrhythmia o Clinically significant valvular heart disease o Patients with cardiomegaly on chest x-ray or ventricular hypertrophy on ECG, unless they demonstrate by MUGA scan within the past 3 months that the LVEF is ≥ the lower limit of normal for the radiology facility; o LVEF below 50% within approximately 28 days prior to randomization o Patients with poorly controlled hypertension i.e. diastolic greater than 100 mm/Hg. (Patients who are well controlled on medication are eligible for entry) o Patients who currently receive medications (digitalis, beta-blockers, calcium channel blockers, etc) that alter cardiac conduction, if these medications are administered for cardiac arrhythmia, angina or congestive heart failure.
- •If these medications are administered for other reasons (e.g., hypertension), the patient will be eligible.
- •Pre-existing grade 2 or greater motor or sensory neuropathy.
- •Women who are pregnant or breast-feeding or women of child bearing potential who are not using effective contraception during participation in the study and do not agree to do so for at least 28 days after final dose of investigational product.
- •Serious underlying medical condition which could impair the ability of patient to participate in the trial (e.g. active systemic infection).
- •Subjects with known acute or chronic infection, including urinary tract infection, HIV, HBsAg, HBV, HCV at the time of screening.
- •Subject participation in another clinical trial within 30 days prior to administration of IP.
结局指标
主要结局
Efficacy will be assessed as Objective Response Rate (Complete Response and Partial Response) by RECIST 1.1 criteria at 25 weeks
时间窗: 25 weeks
次要结局
- 1. To assess the disease progression free survival (PFS) rate(And evaluate ORR at 52 weeks and 2 years)
研究者
研究点 (20)
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