EUCTR2014-001220-30-AT进行中（未招募）1 期
An Open-Label, Phase II, Study to Evaluate Biomarkers Associated with Response to Subsequent Therapies in Subjects with HER2-Positive Metastatic Breast Cancer Receiving Treatment with Trastuzumab in Combination with Lapatinib or Chemotherapy (EGF117165) - DB in 3L MBC
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
- 225
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 written informed consent
- •2. Female Greater than 18 years
- •3. Histologically or cytologially confirmed invasive breast cancer with distant metastasis
- •4. Subjects must have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [Eisenhauer, 2009]
- •Note: Biopsied lesions should not be used as target lesions.
- •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 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 OR HER2/chromosome 17 ratio less than 2.0 with average HER2 copy number =6 signals/cell nucleus];
- •6. Centrally determined HER2-positive, hormone receptor status, breast molecular subtype by PAM50 on the pre-treatment biopsy of metastatic lesion obtained during screening
- •Note: Biopsied lesions should not be used as target lesions.
- •7. Progression on at least 2 lines of anti-HER2-targeted therapies for MBC
- •8. Documented radiological disease progression during the most recent treatment regimen for metastatic disease
- •9. Most recent treatment regimen for metastatic disease must include trastuzumab and chemotherapy.
- •Note: Trastuzumab emtansine (T-DM1) is considered acceptable as prior trastuzumab/chemotherapy regimen
- •10. Agreement to provide 2 tumor biopsies
- •11. Prior treatment with pertuzumab, lapatinib, and/or trastuzumab emtansine is allowed; however, the last treatment for MBC must not include trastuzumab in combination with pertuzumab.
- •12. Subjects with radiographically stable CNS metastases, defined as radiographically stable on the previous 2 brain imaging scans, asymptomatic, and off systemic steroids and anticonvulsants for at least 1 month are eligible; treatment with prophylactic anticonvulsants is permitted unless listed under Prohibited Medications (Section 6)
- •13. Discontinuation of all prior chemotherapy, immunotherapy, or biological therapy at least 3 weeks prior to the first dose of investigational product is required.
- •Note: Discontinuation of trastuzumab is not necessary.
- •14. All treatment related toxicities, except alopecia, must have recovered to Grade 1 or better (Common Terminology Criteria for Adverse Events (CTCAE); version 4.0) prior to administration of the first dose of study treatment.
- •15. Baseline LVEF =50% as measured by ECHO or MUGA and above the testing institution’s lower limit of normal
- •16. QTc <450 msec or QTc <480 msec for patients with bundle branch block. The QTc is the QT interval corrected for heart rate according to either Bazett’s formula (QTcB), Fridericia’s formula (QTcF), or another method, machine or manual overread.
- •For subject eligibility and withdrawal, QT correction formula QTcB will be used.
- •For purposes of this data analysis, Bazett's formula will be used as the primary method of calculating the corrected QT interval. The QTc should be based on either a single ECG or an average of 3 sequential ECGs obtained within 24 hours of each other. The QTc should be based on single or averaged QTc values of triplicate ECGs obtained over a brief recording period.
- •17. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of study treatment and agree to use effective contr
排除标准
- •1. Lactating female
- •Note: Women with potential to have children must be willing to practice acceptable methods of birth control during the study
- •2. Bone-only disease and/or disease that cannot be biopsied.
- •3. Unstable CNS metastases or leptomeningeal carcinomatosis not considered radiographically stable (as defined above in inclusion criterion 12)
- •Note: Subjects with radiographically stable central nervous system (CNS) metastases are defined as radiographically stable on the previous 2 brain imaging studies, asymptomatic, and off systemic steroids and anticonvulsants for at least 1 month; treatment with prophylactic anticonvulsants is permitted unless listed under Prohibited Medications
- •4. Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions including concurrent disease that could interfere with subject’s safety, obtaining informed consent, or compliance with the study procedures.
- •5. Serious cardiac illness or medical condition including but not confined to:
- •-Uncontrolled arrhythmias (e.g. ventricular tachycardia, high-grade atrioventricular (AV)-block, supraventricular arrhythmias which are not adequately rate-controlled);
- •- Angina pectoris requiring antianginal medication;
- •- History of congestive heart failure or systolic dysfunction (LVEF <50%);
- •- Documented myocardial infarction <6 months from study entry;
- •- Evidence of transmural infarction on ECG;
- •- Poorly controlled hypertension (e.g. systolic >160mm Hg or diastolic >100mm Hg);
- •- Clinically significant valvular heart disease.
- •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. Any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels as well as subjects with ulcerative colitis are also excluded
- •8. Any prohibited medication as described in Section 6.2
- •9. Prior treatment with trastuzumab in combination with lapatinib or prior treatment with an irreversible inhibitor of the intracellular domain of the HER2 receptor such as neratinib
- •10. Last treatment for metastatic disease including trastuzumab in combination with pertuzumab
- •11. Administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study treatment
- •12. A known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to any of the study drugs or their excipients that, in the opinion of the investigator or GSK medical monitor, contraindicates participation
- •French subjects must not have participated in any study using an investigational drug during the previous 30 days
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