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临床试验/EUCTR2010-019577-16-IE
EUCTR2010-019577-16-IE进行中(未招募)不适用

A Phase III trial to compare the safety and efficacy of lapatinib plus trastuzumab plus an aromatase inhibitor (AI) versus trastuzumab plus an AI versus lapatinib plus an AI as first- or second-line therapy in postmenopausal subjects with hormone receptor positive, HER2-positive metastatic breast cancer (MBC) who have received prior trastuzumab and endocrine therapies - N/A

GlaxoSmithKline Research & Development Ltd0 个研究点目标入组 525 人开始时间: 2010年11月9日最近更新:
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
525

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

  • Refer to the authorized prescribing information for lapatinib [TYKERB
  • Package Insert, 2010], trastuzumab [HERCEPTIN Package Insert, 2009],
  • letrozole [FEMARA Package Insert, 2010], anastrozole [ARIMIDEX
  • Package Insert, 2009], and exemestane [AROMASIN Package Insert, 2008] for specific information regarding warnings, precautions,
  • contraindications, adverse events, and other pertinent information on
  • the study treatment(s) that may impact subject eligibility.
  • Subjects eligible for enrollment in the study must meet all of the
  • following criteria:
  • 1. Signed written informed consent. In Korea and Japan, subjects who are between
  • =18 and <20 years of age must also have a legal representative sign the
  • written informed consent.
  • 2. Post-menopausal female subjects =18 years of age. Post-menopausal
  • as defined by any of the following:
  • Subjects at least 60 years of age.
  • Subjects under 60 years of age and amenorrhic for at least 12
  • consecutive months AND follicle-stimulating hormone (FSH) and
  • estradiol levels in postmenopausal range (utilizing ranges from the local
  • laboratory facility).
  • Prior bilateral oophorectomy.
  • Prior radiation castration with amenorrhea for at least 6 months
  • 3. Subjects must have a history of histologically confirmed breast cancer,
  • with a clinically confirmed diagnosis of metastatic disease [confirmed by
  • histology, cytology or other clinical means (e.g. CT, MRI)]. Subjects may
  • have either measurable or non-measurable disease per Response
  • Evaluation Criteria in Solid Tumors (RECIST 1.1) [Eisenhauer, 2009]
  • 4. Tumors that are ER+ and/or PgR+ by local laboratory
  • 5. Documentation of HER2 overexpression or gene amplification, in the
  • invasive component of either the primary tumor or metastatic disease
  • site as defined as:
  • 3+ by Immunohistochemistry (IHC)
  • HER2/neu gene amplification by fluorescence, chromogenic or silver in
  • situ hybridization [FISH, CISH or SISH; >6 HER2/neu gene copies per
  • nucleus or a FISH, CISH or SISH test ratio (HER2 gene copies to
  • chromosome 17 signals) of =2.0]
  • 6. Subject must have received at least one prior regimen containing
  • trastuzumab in
  • combination with chemotherapy for breast cancer:.
  • Subject has ONLY received prior trastuzumab in combination with
  • chemotherapy as neoadjuvant and/or adjuvant treatment.
  • Subject has received ONE prior trastuzumab-containing regimen for
  • metastatic disease (and has progressed), and may or may not have
  • received prior trastuzumab in combination with chemotherapy as
  • neoadjuvant and/or adjuvant treatment.
  • 7. Subject must have received prior endocrine therapy (such as
  • aromatase inhibitors or selective estrogen receptor modulators).
  • 8. Subjects who have a life expectancy of > 6 months as assessed by the
  • treating investigator
  • Subjects must have baseline Left Ventricular Ejection Fraction (LVEF)
  • =50% measured by echocardiography (ECHO) or multi-gated acquisition
  • scan (MUGA)
  • 另有 10 项未显示

排除标准

  • Subjects meeting any of the following criteria must not be enrolled in the
  • 1. History of another malignancy.
  • Exception: Subjects who have been disease-free for 5 years, or subjects
  • history of completely resected non-melanoma skin cancer or successfully
  • in situ carcinoma are eligible.
  • 2. Subjects with extensive symptomatic visceral disease including
  • involvement and pulmonary lymphangitic spread of tumor, or the
  • considered by the investigator to be rapidly progressing or life
  • threatening
  • (subjects who are intended for chemotherapy)
  • 3. Serious cardiac illness or medical condition including but not confined
  • . Uncontrolled arrhythmias
  • . Uncontrolled or symptomatic angina
  • . History of congestive heart failure (CHF)
  • . Documented myocardial infarction <6 months from study entry
  • 4. Known history of, or clinical evidence of, central nervous system
  • metastases or leptomeningeal carcinomatosis
  • 5. Have acute or currently active/requiring anti-viral therapy hepatic or biliary disease (with
  • the exception of subjects with Gilbert's syndrome,
  • asymptomatic
  • gallstones, liver metastases or stable chronic liver disease per
  • investigator assessment)
  • 6. Have a concurrent disease or condition that may interfere with study
  • participation,
  • or any serious medical disorder that would interfere with the subject's
  • safety (for
  • example, active or uncontrolled infection or any psychiatric condition
  • prohibiting
  • understanding or rendering of informed consent)
  • 7. Have any clinically significant gastrointestinal abnormalities that may
  • absorption such as malabsorption syndrome or major resection of the
  • stomach or bowels
  • 8. Have a known immediate or delayed hypersensitivity reaction or
  • idiosyncrasy to drugs chemically related to any of the study agents or their excipients
  • that, in the
  • opinion of the Investigator or GSK medical monitor, contraindicates their
  • participation
  • 9. Any prohibited medication as described in Section 6.2.
  • 10. Administration of an investigational drug within 30 days or 5 half-
  • whichever is longer, preceding the first dose of study treatment.

研究者

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