RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY, IN PHASE III WITH LAPATINIB (GW572016) IN COMBINATION WITH PACLITAXEL VERSUS MORE PLACEBO PACLITAXEL IN SUBJECTS WITH METASTASIC BREAST CANCER AMPLIFIED WITH ERBB2

GLAXOSMITHKLINE PERU S.A.,0 个研究点目标入组 18 人开始时间: 2006年6月2日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•1. Male or female ≥18 years.
•2. Histologically confirmed invasive breast cancer with stage IV disease.
•3. Documented amplification of ErbB2 by fluorescence in situ hybridization (FISH) in primary or metastatic tumor tissue.
•4. If a taxane was administered in a neoadjuvant or adjuvant setting, the progression must have occurred> 12 months after completing this treatment and the patient recovering from all associated toxicities.
•5. Measurable lesions according to RECIST.
•6. Radiation therapy as a palliative treatment for painful metastatic disease is allowed but must have stopped within 2 weeks before starting any investigational treatment.
•7. Patients with visceral disease requiring chemotherapy.
•8. Disease that progresses rapidly or threatens life.
•9. Patients who received hormone therapy and who are no longer benefiting from this therapy, and hormonal treatment must have stopped before the first dose of the investigational treatment.
•10. Fraction of cardiac ejection within the normal institutional range as measured by an echocardiogram.
•11. Stored tumor tissue available for testing.
•12. Adequate function of the organs.

•1. Women who are pregnant or breast-feeding at any time during the study.
•2. They received chemotherapy, immunotherapy, biological therapy or previous anti-ErbBl / ErbB2 therapy for metastatic disease.
•3. Previous therapy with an ErbBl and / or ErbB2 inhibitor, in addition to trastuzumab in a coadjuvant setting. If trastuzumab was administered in a coadjuvant setting, then the end of therapy with trastuzumab must have passed> 12 months later.
•4. Serious toxicity unresolved or unstable from previous administration of another investigational drug and / or previous cancer treatment.
•5. Peripheral neuropathy of Grade 2 or higher.
•6. Known history of uncontrolled or symptomatic angina, arrhythmias or congestive heart failure.
•7. Known history or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis.

发起方

GLAXOSMITHKLINE PERU S.A.,