NL-OMON52978已完成2 期
BYLIEVE: A phase II, multicenter, open-label, three-cohort, non-comparative 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 prior treatments - CBYL719X2402 (BYLieve)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 6
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. adult male or female * 18 years old at the time of consent
- •2. Patient has PIK3CA mutation confirmed by a Novartis designated laboratory,
- •Patient has a pathology report confirming PIK3CA mutant status It is also
- •mandatory to
- •provide a tumor sample collected after the most recent
- •progression or recurrence
- •3. Patient has a confirmed, HER2-negative aBC.
- •4. Patient is a men, or pre or postmenopausal woman.
- •Postmenopausal as defined:
- •* Prior bilateral oophorectomy
- •* Age *60
- •* Age <60 and amenorrhea for 12 or more months
- •Special requirements are required for premenopausal women.
- •5. Patient has a confirmed diagnosis of ER+ and/or PgR+ breast cancer , 6.
- •documented evidence of tumor progression
- •- cohort A and B : CDK 4/6 inhibitor treatment as last treatment regimen
- •- cohort C: AI treatment and received systemic chemotherapy or ET as last
- •treatment regimen , 7. Patients must have either:
- •Measurable disease, i.e., at least one measurable lesion as per RECIST v1.1
- •If no measurable disease is present, then at least one predominantly lytic bone
- •lesion must
- •8. Patient has ECOG (Eastern Cooperative Oncology Group) Performance Status * 2
- •9. Males or females with advanced breast cancer not amenable to curative
排除标准
- •1. Patient has received prior treatment with any PI3K inhibitors
- •2. Patients with central nervous system (CNS) involvement unless they meet ALL
- •following criteria:
- •* At least 4 weeks from prior therapy completion 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
- •3. Patient with clinically manifest diabetes mellitus, or documented steroid
- •induced diabetes
研究者
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