EUCTR2011-005189-39-ES进行中（未招募）不适用
A phase III randomized study of TH (Paclitaxel and Trastuzumab) versus THL (Paclitaxel, Trastuzumab and Lapatinib) in first line treatment of HER2-positive metastatic breast cancer - TH v TH
ICORG0 个研究点目标入组 600 人开始时间: 2012年12月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
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.Written informed consent obtained prior to any study-related procedures
- •2.Female age 18 years or greater.
- •3.ECOG Performance Status of 0 or 1.
- •4.Histologically or cytologically-confirmed invasive metastatic breast cancer.
- •5.Patients must have measurable disease according to RECIST criteria Version 1.1, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >20 mm with conventional techniques or as >10 mm with spiral CT scan,MRI, or calipers by clinical exam.
- •6.Tumour shows HER2 over-expression (3+ by IHC and/or FISH + ) by testing of the primary tumour and if available the biopsied metastatic lesion
- •7.Patients who received prior radiotherapy must have completed it at least 4 weeks before registration and recovered from all treatment-related toxicities.
- •8.Cardiac ejection fraction within the institutional range of normal as measured by MUGA or ECHO within 14 days prior to registration. Note that baseline and on treatment scans should be performed using the same modality and preferably at the same institution.
- •9.Adequate haematological, hepatic, and renal function.
- •?Haemoglobin ? 9g/dL
- •?Neutrophils (ANC/AGC) ?1500/mm³ (1.5 x 10^9/L)
- •?Platelets ? (100 x 10^9/L)
- •?Total bilirubin ? 1.5mg/dL (25.65 ?mol/L)
- •?Both ALT (SGPT) and AST (SGOT) ? 3 x ULN with or without liver Metastasis
- •?Alkaline phosphatase ? 2.5 x ULN
- •?Serum creatinine ?1.5 ULN or calculated creatinine clearance (CrCl) ? 30mL/min according to the Cockcroft and Gault formula (Appendix K)
- •10.Able to swallow and retain oral medication.
- •11.Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Female patients of childbearing potential must have pregnancy excluded by urine or serum beta-HCG testing within 7 days prior to registration.
- •12.Estimated life expectancy greater than 12 weeks
- •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 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 600
排除标准
- •1.Prior systemic therapy for metastatic disease (except one line of hormonal therapy for metastatic disease without trastuzumab).
- •2.Recurrence within 12 months from completion of adjuvant chemotherapy to the development of metastatic disease.
- •3.Recurrence within 6 months from completion of adjuvant trastuzumab to the development of metastatic disease.
- •4.Prior lapatinib treatment.
- •5.Peripheral neuropathy ? grade 2
- •6.Patients with known CNS metastasis should be excluded from this clinical trial
- •7.Prior radiotherapy to more than half of the bony pelvis.
- •8.Uncontrolled or symptomatic angina, uncontrolled arrhythmias, congestive heart failure, a documented MI within 6 months prior to registration or any other cardiac disorders, which in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient .
- •9.Immediate or delayed hypersensitivity or untoward reaction to paclitaxel, trastuzumab, or other related compounds, or to drugs chemically related to lapatinib (including other anilinoquinazolines, e.g. gefitinib (Iressa®) and erlotinib (Tarceva®), or other chemically-related compounds).
- •10.Pregnant or breastfeeding women are excluded from this study.
- •11.Patients should not be receiving any other investigational agents (within 30 days prior to registration) or receiving concurrent anticancer therapy.
- •12.Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors (Table 9).
- •13.Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
- •14.Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn?s, ulcerative colitis).
- •15.Have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
- •16.Concurrent treatment with ovarian hormone replacement therapy. Prior treatment must be stopped prior to registration.
研究者
相似试验
进行中（未招募）
1 期
ICORG 11-10/TH v THL: A phase III randomized study of TH (Paclitaxel and Trastuzumab) versus THL (Paclitaxel, Trastuzumab and Lapatinib) in first line treatment of HER2 positive metastatic breast cancer.HER2-positive metastatic breast cancerMedDRA version: 15.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-005189-39-ITICORG600
已完成
不适用
Randomized phase III trial of paclitaxel plus topotecan versus topotecan plus cisplatin in recurrent or persistent cervical cancer stage IVbAdvanced carcinoma of the cervix uteriCervical cancerCancerISRCTN77165120Institute for Women’s Health (Institut fuer Frauengesundheit GmbH) (Germany)326
终止
不适用
A phase III clinical study to compare paclitaxel (Genexol®-PM) in combination with standard therapy (gemcitabine/cisplatin) and standard therapy alone (gemcitabine/cisplatin) in patients with advanced biliary tractNeoplasmsKCT0003726Asan Medical Center220
进行中（未招募）
不适用
A randomized phase III 2-arm trial of paclitaxel plus bevacizumab vs. capecitabine plus bevacizumab for the first-line treatment of HER2-negative locally recurrent or metastatic breast cancerEUCTR2007-005828-32-ATCECOG560
进行中（未招募）
1 期
A randomized phase III 2-arm trial of paclitaxel plus bevacizumab vs. capecitabine plus bevacizumab for the first-line treatment of HER2-negative locally recurrent or metastatic breast cancerEUCTR2007-005828-32-CZCECOG564