PER-052-20已完成未知
EPIK-B3: A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ALPELISIB (BYL719) IN COMBINATION WITH NAB-PACLITAXEL IN PATIENTS WITH ADVANCED TRIPLE NEGATIVE BREAST CANCER WITH EITHER PHOSPHOINOSITIDE-3-KINASE CATALYTIC SUBUNIT ALPHA (PIK3CA) MUTATION OR PHOSPHATASE AND TENSIN HOMOLOG PROTEIN (PTEN) LOSS WITHOUT PIK3CA MUTATIO
ovartis Pharma AG.,0 个研究点目标入组 0 人开始时间: 2020年11月13日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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
入选标准
- •1.Subject is ≥ 18 years old at the time of informed consent and has signed informed consent before any trial related activities and according to local guidelines.
- •2.Subject has histologically confirmed diagnosis of advanced (loco-regionally recurrent and not amenable to curative therapy, or metastatic (stage IV)) TNBC. This diagnosis should be established from the most recently analyzed biopsy from a metastatic or locally recurrent site (local lab) and meet the following criteria:
- •a. HER2 negative in situ hybridization (ISH) test or an immunohistochemistry (IHC) status of 0 or 1+, and
- •b. ER and PR expression is <1 percent as determined by IHC (Hammond et al 2010).
- •Note: Subjects that were previously identified with ER-positive, or PR-positive or HER2-positive early disease are allowed into the study if they have confirmed TNBC (meeting criteria 2a and 2b) by tumor biopsy in the locally advanced or metastatic setting at the time of screening
- •3.Subject has either:
- •a.Measurable disease, i.e., at least one measurable lesion per RECIST 1.1 criteria (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation) OR
- •b.If no measurable disease is present, then at least one predominantly lytic bone lesion or mixed lytic-blastic bone lesion with identifiable soft tissue component (that can be evaluated by Computerized Tomography (CT) /Magnetic Resonance Imaging (MRI)) must be present
- •4.Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
排除标准
- •1.Subject has received prior treatment with any PI3K, mTOR or AKT inhibitor.
- •2.Subject has a known hypersensitivity to alpelisib, nab-paclitaxel or to any of their excipients.
- •3.Subject with inflammatory breast cancer.
- •4.Subject is concurrently using other anti-cancer therapy.
- •5.Subject has had surgery within 14 days prior to starting study drug or has not recovered from major side effects.
- •6.Subject has not recovered from all toxicities related to prior anticancer therapies to NCI CTCAE version 4.03 Grade ≤1. Exception to this criterion: subjects with any grade of alopecia are allowed to enter the study
研究者
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