EUCTR2016-004586-67-ES
进行中（未招募）
1 期
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
ovartis Farmacéutica, S.A.0 个研究点目标入组 160 人2017年4月20日
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Hormone receptor positive, HER2-negative advanced breast cancer
- 发起方
- ovartis Farmacéutica, S.A.
- 入组人数
- 160
- 状态
- 进行中（未招募）
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •\- Patient is male or female 18 years or older
- •\- Patient is identified PIK3CA mutant status
- •\- Patient has confirmed HER2\-negative advanced breast cancer (aBC)
- •\-Patient must be diagnosed with aBC with documented progression on or after CDK 4/6 treatment (adjuvant or metastatic setting)
- •\- Patient has histological and/or cytological confirmed ER\+ and/or PgR\+ aBC
- •\- Patient has either measurable disease per RECIST v1\.1 or at least one predominantly lytic bone lesion must be present
- •\- ECOG function of greater or equal to 2
- •\- Patient has adequate bone marrow function
- •\- Patient has adequate liver and renal function
- •Are the trial subjects under 18? no
排除标准
- •\- patient has received prior treatment with any PI3K inhibitors
- •\- patient with clinically manifest diabetes mellitus, or documented steroid induced diabetes mellitus
- •\-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
- •\-Bilateral diffuse lymphangitis carcinomatosis
- •\-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
结局指标
主要结局
未指定
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