EUCTR2005-003432-22-BE进行中（未招募）1 期
A Randomized, Double Blind, Placebo-Controlled, Multicenter, Phase III Study Comparing the Activity of Paclitaxel Plus Trastuzumab Plus Lapatinib to Paclitaxel Plus Trastuzumab Plus Placebo in Women with ErbB2 Overexpressing Metastatic Breast Cancer
Glaxo SmithKline Research and Development Limited0 个研究点目标入组 765 人开始时间: 2008年1月9日最近更新:
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试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 765
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.Signed informed consent
- •2.Histologically confirmed invasive stage IV breast cancer
- •3.If adjuvant trastuzumab was administered, >=12 months must have elapsed since discontinuation
- •4.If a (neo)adjuvant taxane was administered, progression must have occurred >= 12 months after completion
- •5.Tumours that overexpress ErbB2 defined as either 3+ by IHC OR c-erbB2 gene amplification by FISH OR 0, 1+, 2+ by IHC and c-erbB2 gene amplification by FISH.
- •6.Patients must have tumour tissue available for central testing;
- •7.Measurable lesion(s) according to RECIST
- •8.Subjects must be females >= 18 years.
- •Non-childbearing potential or if of childbearing potential to follow a protocol-specific method of contraception
- •9.Radiotherapy is allowed if patients have completed treatment and recovered from all acute treatment-related toxicities
- •10.Bisphosphonate therapy is allowed if treatment was initiated prior to the first dose of randomized therapy. Prophylactic use of bisphosphonates in patients without bone disease is not permitted, except for the treatment of osteoporosis;
- •11.ECOG Performance Status of 0 to 1;
- •12.For patients whose disease is ER+ and/or PR+ they should have visceral disease that requires chemotherapy or have rapidly progressing or life threatening disease or are no longer benefiting from hormonal therapy
- •13.Able to swallow and retain oral medication;
- •14.Cardiac ejection fraction within institutional range of normal
- •15.Adequate organ function
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Pregnant or lactating females;
- •2.Received prior chemotherapy, immunotherapy, biologic therapy, or anti-ErbB1/ErbB2 therapy for metastatic disease, prior hormonal therapy is permitted but must be discontinued a minimum of 7 days prior to randomization;
- •3.Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Patients with ulcerative colitis are also excluded;
- •4.History of other malignancy; however, patients who have been disease-free for five years, or patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible;
- •5.Concurrent disease or condition that would make the patient inappropriate for study participation, or any serious medical disorder that would interfere with the patient's safety;
- •6.Unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or of prior cancer treatment;
- •7.Peripheral neuropathy of Grade 2 or greater;
- •8.Active or uncontrolled infection;
- •9.Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent;
- •10.Known history of uncontrolled or symptomatic angina, arrhythmias, conduction abnormalities or congestive heart failure;
- •11.Known history or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis;
- •12.Concurrent cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy);
- •13.Concurrent treatment with an investigational agent or participation in another clinical trial;
- •14.Concurrent treatment with any medication on the prohibited medications list 15.Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of treatment;
- •16.Prior therapy with an ErbB2 inhibitor, other than trastuzumab in the adjuvant setting;
- •17.A known immediate or delayed hypersensitivity reaction to drugs chemically related to lapatinib or excipients;
- •18.A known immediate or delayed hypersensitivity reaction to drugs chemically related to paclitaxel or excipients;
- •19.A known immediate or delayed hypersensitivity reaction to drugs chemically related to trastuzumab or excipients;
- •20.Non compliance with any of the screening procedures
研究者
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