EUCTR2021-001966-39-FI进行中（未招募）1 期
EPIK-B5: A Phase III, randomized, double-blind, placebo-controlled study of alpelisib (BYL719) in combination with fulvestrant for men and postmenopausal women with HR-positive, HER2-negative advanced breast cancer with a PIK3CA mutation, who progressed on or after aromatase inhibitor and a CDK4/6 inhibitor - EPIK-B5
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
- 234
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
- •- Participant is an adult = 18 years old at the time of informed consent and has signed informed consent before any trial related activities and according to local guidelines
- •- Participant has a histologically and/or cytologically confirmed diagnosis of ER+ and/or PgR+ breast cancer by local laboratory.
- •- Participant has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (Fluorescent in situ hybridization (FISH), Chromogenic in situ hybridization (CISH), or Silver-enhanced in situ hybridization (SISH)) test is required by local laboratory testing
- •- Participant has at least one measurable lesion as per RECIST v1.1
- •criteria as assessed by Investigator (a lesion at a previously irradiated
- •site may only be counted as a target lesion if there is clear sign of
- •progression since the irradiation).
- •- Participant has recurrence or progression of disease during or after combined AI (i.e. letrozole, anastrozole, exemestane) and CDK4/6 inhibitor therapy. The combined AI and CDK4/6 inhibitor therapy does not need to be the latest treatment regimen (including adjuvant setting).
- •- Participant has received = 2 prior lines of systemic therapies overall in the metastatic setting, of which a maximum of 1 line of prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy) is permitted .
- •- The presence of PIK3CA mutation(s) determined in tumor tissue prior
- •to enrollment either by a Novartis designated laboratory or in tumor
- •tissue or plasma ctDNA by a local laboratory using a Food and Drug
- •Administration (FDA)-approved PIK3CA Companion Diagnostics (CDx)
- •test for alpelisib or the CE-IVD QIAGEN Therascreen® PIK3CA RGQ PCR
- •- If female, then the participant must be in postmenopausal status
- •Further inclusion criteria and details are described in the protocol
- •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 127
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 107
排除标准
- •- Participant with symptomatic visceral disease or any disease burden that makes the participant ineligible for endocrine therapy (ET) per the Investigator’s best judgment.
- •- Participant who relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine /endocrine-based therapy with no treatment for metastatic disease
- •- Participant has received prior treatment with fulvestrant, any oral
- •selective estrogen receptor degrader (SERD)Phosphatidylinositol-3-Kinase (PI3K), mammalian Target of Rapamycin (mTOR) or Protein Kinase B (AKT) inhibitor
- •Further exclusion criteria and details are described in the protocol
研究者
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