A Randomized, Open-Label, Two-Arm Study Of Neratinib Plus Paclitaxel Versus Trastuzumab Plus Paclitaxel As First-Line Treatment For ErbB-2-Positive Locally Recurrent Or Metastatic Breast Cancer

ABORATORIOS WYETH S.A.,0 个研究点目标入组 0 人开始时间: 2010年5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

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: 18 至 120（—）
性别: Female

入选标准

•Female subjects from 18 years of age.
•Diagnosis of breast cancer confirmed histologically or cytologically.
•Metastatic or recurrent breast cancer at the local level that is not treatable with curative surgery or radiation.
•Documentation of amplification of the erbB-2 gene by FISH (as defined by a proportion> 2.2) or in situ chromogenic hybridization (CISH, as defined in the kit manufacturer´s instructions) or overexpression of erbB-2 via IHC (defined as IHC3 + or IHC2 + with confirmation by FISH or CISH) according to local laboratory results or initial diagnosis using 1 of the trials approved by the sponsor. If erbB-2 status is not available or determined using a test other than the sponsor-approved trial and cannot be assessed using one of these trials before randomization, the test and study eligibility must be obtained from the central laboratory identified by the sponsor before randomization.
•All patients should have tumor tissue (that is, the tissue with fixed insert in more recently archived formalin [block or unstained preparations]) for central revision of erbB-2 expression levels by FISH test performed by the Central laboratory identified by the sponsor.
•Before entering the study, documentation of ER / PgR status (positive / negative according to local laboratory results or initial diagnosis should be available. If results are not available, tumor tissue may be sent to the central laboratory identified by the sponsor to evaluate it before entering the study according to the criteria of the researcher.
•At least one quantifiable lesion, according to the Criteria of evaluation of the response in solid tumors (RECIST).
•Status from O to 2 according to the Eastem Cooperative Oncology Group (ECOG) (not decreasing within 2 weeks prior to the signing of the informed consent).
•Left ventricular ejection fraction (LVEF) within the normal institutional range, as measured by radioisotopic ventriculography (MUGA) or echocardiogram (ECHO).
•Recovery (at level 1 or baseline) of all clinically significant acute adverse effects of previous therapies (not including alopecia).
•All women who are not surgically sterile or postmenopausal should agree and commit to using a reliable contraceptive method from 2 weeks before the administration of the first dose of the product under investigation and up to 28 days after the last dose of the product in investigation. A woman with reproductive capacity is one who is in a biological position to conceive. This includes women who are using contraceptives or those whose sexual partners are sterile or use contraceptives.

排除标准

•Previous systemic anti-cancer therapy (which includes cytotoxic chemotherapy, signal transduction inhibitors [for example, lapatinib], biological therapy [for example, trastuzumab] or other anti-cancer therapy under investigation) for metastatic or recurrent disease at the local level. Prior endocrine therapy is allowed in any context.
•Previous treatment with an erbB-2 inhibitor, other than trastuzumab, lapatinib or the combination of both, in the neoadjuvant or adjuvant context.
•Previous treatment with neoadjuvant or adjuvant anthracyclines with a cumulative dose of doxorubicin of> 400 mg / m ´´, epirubicin dose of> 800 mg / m or the equivalent dose of other anthracyclines or derivatives (for example, 72 mg / m ^ 2 of mitoxantrone).
•Subjects with recurrent or progressive disease within 12 weeks after the end of a neoadjuvant or adjuvant systemic anticancer therapy (which includes cytotoxic chemotherapy, signal transduction inhibitors [eg, lapatinib], biological therapy [eg, trastuzumab ] or other anticancer therapy under investigation), other than endocrine therapy for early breast cancer.
•Subjects in which bones or skin are the only focus of the quantifiable disease. Subjects with quantifiable skin lesions by computed tomography (CT) or magnetic resonance imaging (MRI) images, since only quantifiable disease sites are admitted.
•Major surgery, chemotherapy, radiation therapy, any investigating agent or other cancer therapy within 2 weeks prior to the administration of the first dose of the product under investigation.
•Uncontrolled or symptomatic active CNS metastasis, as indicated by clinical symptoms, cerebral edema or progressive growth. Subjects with a history of CNS metastasis or spinal cord compression are eligible if they have received definitive treatment and are not being treated with anticonvulsants and steroids for a minimum of 4 weeks prior to the first dose of the product under investigation.
•Uncontrolled active heart disease, which includes cardiomyopathy, congestive heart failure (functional classification of> 3 of the New York Heart Association [NYHA]), unstable angina and myocardial infarction (within 12 months of admission to the study).
•Inappropriate controlled hypertension (ie systolic blood pressure [BP]> 180 mm Hg or diastolic blood pressure> 100 mm Hg).
•Family history of congenital long or short QT syndrome, Brugada syndrome or QT / QTc interval> 0.45 seconds or known history of prolongation of QT / QTc or torsade de pointe (TdP).
•Significant chronic gastrointestinal disorder with diarrhea as the main symptom (for example, Crohn´s disease, malabsorption or diarrhea of grade> 2 of any etiology at the beginning).
•Pre-existing sensory or motor neuropathy grade 2 or higher.
•History of hypersensitivity reaction with life risk to taxanes or trastuzumab.
•Clinical contraindication of steroids that prevents its use as part of the premedication of paclitaxel.
•Pregnant, breastfeeding women or women with reproductive capacity who are not using effective contraceptive methods during study participation and do not agree to use them for at least 28 days after the final dose of the product under investigation.
•Impossibility or reluctance to swallow oral medications.

研究者

发起方

ABORATORIOS WYETH S.A.,

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