EUCTR2010-019577-16-NO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-line therapy in postmenopausal subjects with hormone receptorpositive, HER2-positive metastatic breast cancer (MBC) who have received trastuzumab and endocrine therapy in the neoadjuvant and/or adjuvant setting - N/A
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
- •Subjects eligible for enrollment in the study must meet all of the following criteria:
- •1. Signed written informed consent
- •2. Post-menopausal female subjects =18 years of age. Post-menopausal as defined
- •by any of the following:
- •Age > 60 years
- •Age = 45 years with amenorrhea > 12 months with an intact uterus
- •Having undergone a bilateral oophorectomy or radiation castration with
- •amenorrhea for at least 6 months
- •FSH and estradiol levels in postmenopausal range (utilizing ranges from the
- •local laboratory facility). In subjects who have previously been treated with
- •an GnRH/LHRH analogue, the last injection must have been administered >
- •4 months prior to randomization and menses must not have restarted
- •3. Histologically confirmed Stage IV invasive breast cancer
- •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 prior neoadjuvant and/or adjuvant trastuzumab
- •7. Subject must have received prior neoadjuvant and/or adjuvant endocrine therapy
- •8. Subjects who have a life expectancy of > 6 months as assessed by the treating
- •investigator
- •9. Have baseline of Left Ventricular Ejection Fraction (LVEF) =50% measured by
- •echocardiography (ECHO) or multi-gated acquisition scan (MUGA)
- •10. ECOG performance status of 0-1 (Section 12.2, Appendix 2)
- •11. All prior treatment related toxicities must be CTCAE (Version 4.0) = Grade 1
- •[NCI, 2009] at the time of randomization
- •12. Completion of screening assessments
- •13. Adequate baseline organ function defined by: (Refer to page 26 of Protocol)
- •French subjects: In France, a subject will be eligible for inclusion in this study only if
- •either affiliated to or a beneficiary of a social security category.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 340
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 185
排除标准
- •Subjects meeting any of the following criteria must not be enrolled in the study:
- •1. History of another malignancy.
- •Exception: Subjects who have been disease-free for 5 years, or subjects with a
- •history of completely resected non-melanoma skin cancer or successfully treated
- •in situ carcinoma are eligible.
- •2. Subjects with extensive symptomatic visceral disease including hepatic
- •involvement and pulmonary lymphangitic spread of tumor, or the disease is
- •considered by the investigator to be rapidly progressing or life threatening
- •(subjects who are intended for chemotherapy)
- •3. Subjects who received prior chemotherapy, hormonal therapy, immunotherapy,
- •biologic therapy, or anti-HER2 therapy for advanced or metastatic disease
- •4. Serious cardiac illness or medical condition including but not confined to:
- •Uncontrolled arrhythmias
- •Uncontrolled or symptomatic angina
- •History of congestive heart failure (CHF)
- •Documented myocardial infarction <6 months from study entry
- •5. Known history of, or clinical evidence of, central nervous system (CNS)
- •metastases or leptomeningeal carcinomatosis
- •6. Current active hepatic or biliary disease (with exception of subjects with Gilbert's
- •syndrome, asymptomatic gallstones, liver metastases or stable chronic liver
- •disease per investigator assessment)
- •7. 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)
- •8. Have any clinically significant gastrointestinal abnormalities that may alter
- •absorption such as malabsorption syndrome or major resection of the stomach or
- •9. 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
- •10. Any prohibited medication as described in Section 6.2.
- •11. Administration of an investigational drug within 30 days or 5 half-lives,
- •whichever is longer, preceding the first dose of study treatment.
研究者
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