2023-509167-24-00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 withPIK3CA mutant, hormone receptor (HR) positive, HER2-negative advanced breast cancer (aBC), who have progressed on or after prior treatments.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- The primary endpoint of this study is the proportion of patients who are alive without disease progression at 6 months based on local investigator assessment using RECIST v1.1 in each cohort
研究概览
简要总结
To assess the proportion of patients who are alive without disease progression at 6 months based on local investigator assessment per RECIST v1.1 separately in cohorts A and C (alpelisib in combination with fulvestrant) and cohort B (alpelisib in combination with letrozole) among patients with HR+, HER2-negative aBC harboring a PIK3CA mutation who have progressed on or after prior treatments
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
- 是
入选标准
- •Patient is an adult male or female ≥ 18 years old
- •Patient has adequate bone marrow function
- •Patient has adequate tumor tissue for the analysis of PIK3CA mutational status by a Novartis designated laboratory. It is recommended to provide a tumor sample collected after the most recent progression or recurrence
- •Advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy
- •Patient has been confirmed as PIK3CA mutant as determined by a certified designated laboratory
- •Patient has histologically and/or cytologically confirmed ER+ and/ or PgR+ BC
- •Patient has confirmed, HER2-negative aBC. HER2-negative defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+ or 2+
- •Patients must be diagnosed with aBC, with documented evidence of tumor progression on or after prior treatments. No more than one prior regimen of chemotherapy for the treatment of metastatic disease is permitted. The maximum number of prior therapies for aBC or mBC is limited to two (maintenance therapies, where applicable, must be regarded as part of the main therapy). Patients must have recovered to grade 1 or better from any adverse events (except alopecia) related to previous therapy prior to study entry
- •Patient has either measurable disease, i.e. at least one measurable lesion as per RECIST v1.1 criteria or if no measurable disease is present than at least one predominantly lytic bone lesion must be present
- •Patient has ECOG performance status of ≤ 2
排除标准
- •Patient has received prior treatment with any PI3K inhibitors
- •Patients with an established diagnosis of diabetes mellitus type I or uncontrolled type II (based on FG and HbA1c in inclusion criterion 11)
- •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, nonmelanoma 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 (with the exception of alopecia)
- •Patients receiving systemic corticosteroids ≤ 2 weeks prior to treatment with alpelisib
- •History of acute pancreatitis within 1 year of screening or past medical history of pancreatitis
- •Patient has impaired GI function or GI disease that may affect the absorption of study drugs
- •Patient has documented pneumonitis
- •Patients being concurrently treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme Cytochrome P (CYP)3A within the last 5 days prior to study entry
结局指标
主要结局
The primary endpoint of this study is the proportion of patients who are alive without disease progression at 6 months based on local investigator assessment using RECIST v1.1 in each cohort
The primary endpoint of this study is the proportion of patients who are alive without disease progression at 6 months based on local investigator assessment using RECIST v1.1 in each cohort
次要结局
- PFS based on local investigator assessment using RECIST v1.1 in each cohort
- PFS2 based on local investigator assessment in each cohort
- ORR based on local investigator’s assessment according to RECIST v1.1 in each cohort Clinical Benefit Rate (CBR) based on local investigator’s assessment according to RECIST v1.1 in each cohort
- Duration of Response is the time from the date of first documented response (confirmed CR or PR) to the date of first documented progression or death
- Overall Survival is defined as the time of start of treatment to date of death or lost to follow-up
- Type, frequency and severity of adverse events per CTCAE v4.03 Type, frequency and severity of laboratory toxicities per CTCAE v4.03
- Proportion of patients with clinical benefit as assessed by the Investigator at scheduled visits
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (2)
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