EUCTR2010-019390-15-PL进行中（未招募）不适用
A Phase II, Randomized, Open-label Study of Lapatinib Plus Chemotherapy versus Trastuzumab Plus Chemotherapy as Firstline Treatment for Women with HER2-positive and p95HER2-positive Metastatic Breast Cancer - n/a
适应症
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
- 300
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. Female =18 years of age
- •2. Histologically or cytologically confirmed invasive breast cancer with distant metastasis(ses) (designated as Stage IV or metastatic breast cancer)
- •Diagnosis with Stage IV or metastatic disease at either primary diagnosis or
- •3. Not received prior systemic or local treatment (e.g., chemotherapy, endocrine or
- •radiotherapy) for Stage IV/metastatic breast cancer
- •Prior adjuvant and/or neo-adjuvant therapy is permitted
- •4. Documentation of HER2 overexpression or gene amplification, in the invasive
- •component of either a metastatic disease site or primary tumor, defined as:
- •3+ by 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
- •5. Documentation by the central laboratory of positive p95HER2 expression in the
- •invasive component of either a metastatic disease site (preferred) or primary tumor
- •6. No history of CNS metastases (including leptomeningeal involvement) or stable
- •CNS metastases (defined as asymptomatic and off steroids for =3 months)
- •7. Baseline Left Ventricular Ejection Fraction (LVEF) =50% measured by
- •echocardiography (ECHO) or multi-gated acquisition scan (MUGA)
- •8. Recovered or stabilized from all adverse events associated with prior anti-cancer
- •therapies, including radiotherapy, at the time of screening
- •9. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- •10. Have adequate marrow and organ function as defined in protocol
- •11. Women of childbearing potential, including women whose last menstrual period was <12 months ago (unless surgically sterile) must have a negative serum pregnancy test and agree to use effective contraception, as defined in Section 7.4 of protocol.
- •12. Signed Informed Consent Form
- •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
- •History of other malignancy.
- •Exception: Subjects who have been disease-free for 5 years or subjects with a history of completely resected non-melanoma skin cancer (basal or squamous) are eligible
- •2. Concurrent anti-cancer treatment or concurrent treatment with an investigational
- •3. Administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study treatment
- •4. Prior treatment with anti-HER2 therapy, except trastuzumab or lapatinib (time from
- •last dose of trastuzumab or lapatinib to randomization must be =3 months)
- •5. 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
- •6. Current active hepatic or biliary disease (with exception of Gilbert's syndrome,
- •asymptomatic gallstones, liver metastases or stable chronic liver disease per
- •investigator assessment)
- •7. Concurrent disease or condition, or any pre-existing medical disorder that in the
- •opinion of the investigator may interfere with the subject’s safety, obtaining
- •informed consent or compliance to the study procedures
- •8. Pregnant or lactating female
- •9. Any clinically significant gastrointestinal abnormalities that may alter absorption
- •such as malabsorption syndrome or major resection of the stomach or bowels
- •(consult with GSK Medical Monitor if uncertain about eligibility)
- •10. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
- •chemically related to any of the study drugs or their excipients (Refer to Section 5.1. of protocol)
- •that, in the opinion of the investigator contra-indicates participation
研究者
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