EUCTR2016-004586-67-IT进行中（未招募）1 期
BYLieve: A phase II, multicenter, open-label, two-cohort, noncomparative study to assess the efficacy and safety of alpelisib plus fulvestrant or letrozole in patients with PIK3CA mutant, hormone receptor (HR) positive, HER2-negative advanced breast cancer (aBC), who have progressed on or after CDK 4/6 inhibitor treatment - BYLieve
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
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
- •- Patient is male or female 18 years or older
- •- Males or females with advanced (locoregionally recurrent or
- •metatstatic) breast cancer not amenable to curative therapy
- •- Patient has histological and/or cytological confirmed ER+ and/or PgR+
- •- Patient has confirmed HER2-negative advanced breast cancer (aBC)
- •- Patient is identified PIK3CA mutant status
- •- In case of women, both premenopausal and postmenopausal patients
- •are allowed to be included in study; menopausal status is relevant for
- •the requirement of LHRH agonist
- •-Patient must have documented evidence of tumor progression on or after CDK 4/6 combination treatment
- •- Patient has either measurable disease per RECIST v1.1 or at least one
- •predominantly lytic bone lesion must be present
- •- Patient has adequate bone marrow function
- •- Patient has adequate liver and renal function
- •- ECOG function of greater or equal to 2
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 130
排除标准
- •letrozole or to any of the excipients of alpelisib, fulvestrant or letrozole
- •- patient has received prior treatment with any PI3K inhibitors
- •- patient with with an established diagnosis of diabetes mellitus type I or
- •uncontrolled type II
- •-Patient has a concurrent malignancy or malignancy within 3 years of
- •study screening period, with the exception of adequately treated, basal
- •or squamous cell carcinoma, non-melanoma skin cancer or curatively
- •resected cervical cancer
- •-Patient has received radiotherapy = 4 weeks or limited field radiation
- •for palliation = 2 weeks prior to enrollment, and who has not recovered
- •to grade 1 or better from related side effects of such therapy
- •-History of acute pancreatitis within 1 year of screening or past medical
- •history of pancreatitis
- •-Patients with central nervous system (CNS) involvement unless they
- •meet ALL of the following criteria:
- •At least 4 weeks from prior therapy completion (including radiation
- •and/or surgery) to starting the study treatment
- •Clinically stable CNS tumor at the time of screening untreated or
- •without evidence of progressions for at least 4 weeks after treatment as
- •determined by clinical examination and brain imaging (MRI or CT) during
- •screening period and stable low dose of steroids for 2 weeks prior to
- •initiating study treatment
- •-Patient with severe liver impairment (Child Pugh score B/C)
- •-Patient has impairment of gastrointestinal (GI) function or GI disease
- •that may significantly alter the absorption of the study drugs
- •-Patient has documented pneumonitis which is active and requiring
- •For all exclusion criteria, please refer to protocol section 5.3
研究者
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