A Phase II, multi-center, open-label, neoadjuvant, randomized study of weekly paclitaxel with or without LCL161 in patients with triple negative breast cancer

OVARTIS FARMA0 个研究点目标入组 100 人2012年11月6日

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Women with triple negative breast cancer whose tumors are positive fora defined pattern of gene expression
发起方: OVARTIS FARMA
入组人数: 100
状态: 进行中（未招募）
最后更新: 10年前

暂无简介。

注册库

who.int

开始日期

2012年11月6日

结束日期

待定

最后更新

10年前

研究类型

Interventional clinical trial of medicinal product

性别

Female

发起方

•1\. Adult female (\=18 years old)
•2\. Histologically confirmed diagnosis of invasive breast cancer, previously untreated (patients who have been treated for cancer of the contralateral breast can be included if there is at least a 2 year interval from last systemic treatment for breast cancer before randomization for this study). Disease must be negative immunohistochemically for estrogen and progesterone receptors (\=1% of nuclei positive by IHC) and must not have
•Her2 overexpression (by Herceptest or validated IHC assay; 0\-1\+ staining) or in cases of ambiguous Her2 expression (2\+ staining), Her2 amplification (by CISH or FISH).
•3\. Positive for the LCL161 predictive gene expression profile as determined during molecular pre\-screening
•4\. Candidates for mastectomy or breast\-conserving surgery
•5\. Primary tumor of greater than 20 mm and less than 50 mm diameter measured by imaging (American Joint Committee on Cancer (AJCC) TNM stage T2\)
•6\. Regional lymph node AJCC TNM stages N0\-N2:
•a. N0: No regional lymph node metastases
•b. N1: Metastases to movable ipsilateral axillary lymph nodes
•c. N2: Metastases in ipsilateral axillary nodes that are fixed or matted, or in clinically apparent ipsilateral internal mammary nodes in the absence of axillary node metastases (Clinically apparent is defined as detected by clinical examination, grossly visible disease pathologically, or imaging studies (excluding lymphoscintigraphy))

•1\. Multicentric invasive tumors (defined as additional foci of tumor outside the breast quadrant containing the primary tumor); bilateral or inflammatory breast cancer (bilateral
•mammography is required during Screening/baseline); locally recurrent breast cancer
•2\. Patients currently receiving systemic therapy for any other malignancy, or having received
•systemic therapy for a malignancy in the preceding 3 months
•3\. Any concurrent severe and/or uncontrolled medical conditions that could increase the patient’s risk for toxicity while in the study or that could confound discrimination between
•disease\- and study treatment\-related toxicities
•4\. Uncontrolled cardiac disease including:
•a. History or presence of ventricular tachyarrhythmia
•b. Unstable atrial fibrillation (ventricular response \=100 bpm). Patients with stable atrial
•fibrillation are eligible provided they do not meet any of the other cardiac exclusion criteria