A RANDOMIZED, MULTICENTER, OPEN-LABEL, TWO-ARM, PHASE III NEOADJUVANT STUDY EVALUATING TRASTUZUMAB EMTANSINE PLUS PERTUZUMAB COMPARED WITH CHEMOTHERAPY PLUS TRASTUZUMAB AND PERTUZUMAB FOR PATIENTS WITH HER2-POSITIVE BREAST CANCER.

F. Hoffmann-La Roche Ltd0 个研究点目标入组 432 人开始时间: 2014年8月14日最近更新: 2018年9月10日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: F. Hoffmann-La Roche Ltd
入组人数: 432

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 clinical trial of medicinal product

入排标准

性别: All

入选标准

•- age = 18 years
•- Histologically confirmed invasive breast cancer with a primary tumor size of > 2 cm
•- HER2-positive breast cancer
•- Patients with multifocal tumors (more than one tumor confined to the same quadrant as the primary tumor) if all discrete lesions are sampled and centrally confirmed as HER2-positive
•- Stage at presentation: cT2-cT4, cN0-cN3, cM0
•- Known hormone receptor status of the primary tumor
•- Patient agreement to undergo mastectomy or breastconserving surgery after neoadjuvant therapy
•- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•-Adequate hematologic, renal and liver funciton
•- Baseline LVEF = 55% measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA)
•-Negative serum pregnancy test results for women of childbearing potential and for women who have experienced menopause onset < 12 months prior to randomization
•-Documentation of hepatitis B virus and hepatitis C virus serology is required
•- Effective contraception as defined by protocol.
•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 368
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 64

排除标准

•- Stage IV (metastatic) breast cancer
•- Patients who have received prior anti-cancer therapy for breast cancer except those patients with a history of breast lobular carcinoma in situ (LCIS) that was surgically managed or ductal carcinoma in situ (DCIS) treated
•exclusively with mastectomy. In case of prior history of LCIS/DCIS, >5 years must have passed from surgery until diagnosis of current breast cancer
•- Patients with multicentric (multiple tumors involving more than 1 quadrant) or bilateral breast cancer
•- Patients who have undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes
•- Axillary lymph node dissection or positive sentinel lymph node prior to start of neoadjuvant therapy.
•- History of concurrent or previous non-breast malignancies except for appropriately treated (1) nonmelanoma skin cancer and (2) in situ carcinomas, including cervix, colon, and skin. A patient with previous invasive non-breast cancer is eligible provided he/she has been disease-free 5 years
•- Treatment with any investigational drug within 28 days prior to randomization
•- Current National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 Grade = 2 peripheral neuropathy
•- Cardiopulmonary dysfunction as defined by the protocol
•- Any significant concurrent medical or surgical conditions or findings that would jeopardize the patient's safety or ability to complete the study
•- Major surgical procedure unrelated to breast cancer or significant traumatic injury within 28 days prior to randomization
•- Known hypersensitivity to study drugs, excipients and/or murine proteins
•- Concurrent, serious, uncontrolled infections or known infection with HIV
•- Any known active liver disease, e.g. due to HBC, HCV, autoimmune hepatic disorders, or sclerosing cholangitis
•- Pregnancy or breastfeeding.

研究者

发起方

F. Hoffmann-La Roche Ltd

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