EUCTR2010-019577-16-BG进行中（未招募）1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 345
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
- •9. Subjects must have baseline Left Ventricular Ejection Fraction (LVEF) =50% measured by echocardiography (ECHO) or multi-gated acquisition scan (MUGA)
- •10. Subject must have an 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 Protocol page 27)
- •14. Subjects must meet all of the following criteria:
- •QTc <450msec or
- •QTc <480msec for subjects with bundle branch block
- •The QTc is the QT interval corrected for heart rate according to either Bazett’s formula (QTcB) or to Fridericia’s formula (QTcF), machine or manual over read,
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. 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
- •4. Known history of, or clinical evidence of, central nervous system (CNS)
- •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 alter
- •absorption such as malabsorption syndrome or major resection of the stomach or
- •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-lives,
- •whichever is longer, preceding the first dose of study treatment.
研究者
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