2024-512050-13-00已完成3 期
EPIK-B2: A two part, Phase III, multicenter, randomized (1:1), double-blind, placebo-controlled study to assess the efficacy and safety of alpelisib (BYL719) in combination with trastuzumab and pertuzumab as maintenance therapy in patients with HER2-positive advanced breast cancer with a PIK3CA mutation
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 4
- 主要终点
- Safety run-in Part 1: Incidence of DLTs during the first 6 weeks of treatment for each dose level associated with administration of alpelisib in combination with trastuzumab and pertuzumab
研究概览
简要总结
Safety run-in Part 1: To confirm the Recommended Phase 3 Dose of alpelisib in combination with trastuzumab and pertuzumab Double-blind, randomized, placebo-controlled Part 2: To determine whether treatment with alpelisib in combination with trastuzumab and pertuzumab prolongs PFS compared to placebo in combination with trastuzumab and pertuzumab in adult participants with HER2-positive advanced breast cancer with a PIK3CA mutation.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Participant has histologically-confirmed HER2-positive breast cancer that is advanced (loco-regionally recurrent not amenable to surgery or metastatic).
- •Participant has received pre-study induction therapy with up to and including a maximum of 8 cycles of a taxane (docetaxel, paclitaxel, or nab-paclitaxel), plus trastuzumab and pertuzumab. A minimum of 4 cycles of induction therapy is permitted if discontinuation of taxane was due to taxane toxicity.
- •Participant has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Participant has adequate bone marrow and organ function
- •Applies only to Part 2: Participant has a PIK3CA mutation(s) present in tumor tissue prior to enrollment, as determined by a Novartis designated central laboratory.
排除标准
- •Participant with inflammatory breast cancer at screening.
- •Participant with evidence of disease progression during or following completion of pre-study induction therapy and prior to first dose of alpelisib (or alpelisib/alpelisib matching-placebo for Part 2)
- •Participant with an established diagnosis of diabetes mellitus type I or not controlled type II based on fasting plasma glucose (FPG) and HbA1c.
- •Participant has a known history of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis
- •Participant has clinically significant, uncontrolled heart disease and/or recent cardiac events
- •Participant has a history of Steven-Johnson Syndrome (SJS), erythema multiforme (EM), Toxic Epidermal Necrolysis (TEN) or Drug Reaction with Eosinophilia and Systemic Syndrome (DRESS).
- •Participant has currently documented pneumonitis/interstitial lung disease
结局指标
主要结局
Safety run-in Part 1: Incidence of DLTs during the first 6 weeks of treatment for each dose level associated with administration of alpelisib in combination with trastuzumab and pertuzumab
Safety run-in Part 1: Incidence of DLTs during the first 6 weeks of treatment for each dose level associated with administration of alpelisib in combination with trastuzumab and pertuzumab
Double-blind, randomized, placebo-controlled Part 2: PFS based on Investigator assessment using RECIST 1.1 criteria
Double-blind, randomized, placebo-controlled Part 2: PFS based on Investigator assessment using RECIST 1.1 criteria
次要结局
- Safety run-in Part 1: Safety: Incidence, type, and severity of adverse events per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 criteria including changes in laboratory values, vital signs, liver assessments and cardiac assessments Tolerability: dose interruptions, reductions, dose intensity, and duration of exposure for all drug components
- Safety run-in Part 1: Summary statistics of alpelisib concentrations by timepoint and dose level
- Double-blind, randomized, placebo-controlled Part 2: OS
- Double-blind, randomized, placebo-controlled Part 2: Safety: Incidence, type, and severity of adverse events per CTCAE version 4.03 criteria including changes in laboratory values, vital signs, liver assessments and cardiac assessments Tolerability: dose interruptions, reductions, dose intensity, and duration of exposure for all drug components
- Double-blind, randomized, placebo-controlled Part 2: ORR with confirmed response, CBR with confirmed response, DOR with confirmed response, and TTR based on local radiology assessments and using RECIST 1.1 criteria.
- Double-blind, randomized, placebo-controlled Part 2: Summary statistics of concentrations for alpelisib by time point
- Double-blind, randomized, placebo-controlled Part 2: Change from baseline in the FACT-B Trial Outcomes Index (TOI) score. Time to 5-point definitive deterioration in the TOI score of the FACT-B
- Double-blind, randomized, placebo-controlled Part 2: PFS based on local radiology assessments and using RECIST 1.1 criteria for participants by PIK3CA mutation status assessed in ctDNA at baseline
- Double-blind, randomized, placebo-controlled Part 2: Time to definitive deterioration of the ECOG performance status from baseline
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (4)
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