RANDOMIZED, MULTICENTER, OPEN, PHASE III,STUDY OF LAPATINIB, TRASTUZUMAB AND ITS COMBINATION IN NEOADYUVANCIA MORE PACLITAXEL IN WOMEN WITH PRIMARY BREAST CANCER HER2 / ERBB2 POSITIVE

OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 38 人开始时间: 2007年11月21日最近更新: 2023年9月4日

适应症

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 38

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 0 至 0（—）

入选标准

•Female sex;
•Age 18 years;
•Functional status ~ Eastern Cooperative Oncology Group (ECOG) 0-1 (see Appendix 2);
•Invasive breast cancer confirmed histologically: - primary tumor greater than 2 cm in diameter, measured by mammography and ultrasound, - any N, - no evidence of metastasis (MO) (supraclavicular ganglion involvement is allowed alone);
•Over-expression and / or amplification of HER2 in the invasive component of the primary tumor according to one of the following definitions [Wolff et al 2006] and confirmed by a laboratory certified before the random distribution (see Section 5.2): - 3+ overexpression by IHC (> 30% of invasive tumor cells); - overexpression 2+ or o + (in 3U% or less neoplastic cells) by IHC and in situ Hybridization test (FISH / CISH) demonstrating amplification of the HER2 gene; - Amplification of the HER2 gene by FISH / CISH (> 6 copies of the HER2 gene per nucleus or a FISH index [copies of the HER2 gene to signals on chromosome 17] of> 2.2.) Subjects with negative or equivocal general results ( index of the FISH test of <2.2, <6.0 copies of the HER2 gene per nucleus) and O, 1+, 2+ or 3+ staining scores (in 30% or less of the neoplastic cells) per IHC they are not eligible for participation in the Study.
•Misleading local results from non-certified laboratories can be sent for a final determination in a certified laboratory.
•The status of ErbB2 should be studied in certified local or regional laboratories prior to randomisation. If a local FISH test is performed in non-certified laboratories, the Path´Vysion (Vysis) or INFORM HER2 / neu (Inc. Window) test should be used, but they will also need confirmation of the results by a certified laboratory. IHC over-expression scores obtained locally will also require confirmation from a certified laboratory to be considered as entry criteria. Subjects with negative FISH / CISH local tests (test score <1.8, <4.0 copies of the ErbB2 gene per nucleus) or with IHC scores O and 1+ are not eligible for participation in the Study. Positive local FISH tests (> 6 copies of the ErbB2 gene per core or a FISH index of more than 2.2) or 2/3 + overexpression by the IHC obtained in non-certified local laboratories, must be confirmed in one of the certified laboratories before of the random distribution;
•Hormone receptor (HR) status: - The status of the estrogen receptor (ER) must be known.
•Hematopoietic status: - Absolute neutrophil count> 1.5 x 10 9/1, - Platelet count> 100 x 10 9/1, - Hemoglobin of at least 9 g / dl,
•Hepatic status: - Bilirubin • Kidney status: - Creatinine • Cardiovascular: - baseline LVEF> 50% measured by echocardiography (ECHO) or controlled multiple-scan study (MUGA),
•Serum negative pregnancy test, within 2 weeks (preferably 7 days) prior to randomization (for women with reproductive potential)
•Fertile subjects should use effective contraception (barrier method - condoms, diaphragm - also together with spermicidal gel or total abstinence - oral, injectable or implantable hormonal contraceptives are not allowed)
•Final informed consent form (FCI)
•The subject agrees to deliver samples of the tumor to send to the central laboratory and perform translational studies as part of this protocol

排除标准

•Administration of pre-treatment for invasive primary breast cancer;
•History of another malignant disease. However, participants with a past or current history of squamous and basal carcinoma of completely resected skin or subjects successfully treated for carcinoma in situ of the cervix are eligible;
•Diagnosis of inflammatory breast cancer;
•Bilateral cancer;
•Multifocal cancer;
•Known antecedents of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, uncontrolled hypertension (> / = 180 / l 10), unstable diabetes mellitus, dyspnea at rest or chronic treatment with oxygen;
•Illness or concomitant condition that would make the subject unsuitable for participation in the study or any serious medical condition that could interfere with the subject´s safety;
•Serious unresolved or unstable adverse events from the previous administration of another investigational product;
•Active or uncontrolled infection;
•Dementia, altered mental state or any psychiatric condition that could impede the understanding or grant of the FCI;
•Malabsorption syndrome, disease that. Significantly affect gastrointestinal function, or resection of the stomach or small intestine. Subjects with ulcerative colitis are also excluded;
•Therapy for concurrent neoadjuvant cancer (chemotherapy, radiation therapy, immunotherapy, biological therapy, different from the treatments of the Study);
•Concomitant treatment with a drug in research or participation in another therapeutic clinical study;
•Reaction of immediate or delayed hypersensitivity known or idiosyncrasy to drugs chemically related to trastuzumab or lapatinib or its excipients;
•Pregnant or breastfeeding women;
•Concomitant use of inhibitors or inducers of CYP3A4 (see Section 7.2 for the list of prohibited medications).

研究者

发起方

OVARTIS BIOSCIENSES PERU S.A.,

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