2023-503990-39-00招募中3 期
SERENA-6: A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor vs Continuing Aromatase Inhibitor (Letrozole or Anastrozole) + CDK4/6 Inhibitor in HR+/HER2- MBC Patients with Detectable ESR1 Mutation Without Disease Progression During 1L Treatment with Aromatase Inhibitor + CDK4/6 Inhibitor A ctDNA Guided Early Switch Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 108
- 主要终点
- Progression-free survival (PFS) is defined as the time from randomisation until progression per RECIST 1.1 as assessed by the investigator at the local site, or death due to any cause.
研究概览
简要总结
To demonstrate superiority of AZD9833 plus CDK4/6 inhibitor relative to AI plus CDK4/6 inhibitor by assessment of PFS in the FAS
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Proven diagnosis of adenocarcinoma of the breast with evidence of locoregionally recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent.
- •Documentation of histologically confirmed diagnosis of estrogen receptor positive (ER+) /HER2- breast cancer based on local laboratory results.
- •Currently on AI (letrozole or anastrozole) + CDK4/6 inhibitor ± LHRH as the initial endocrine based treatment for advanced disease
- •Eastern Cooperative Oncology Group performance status of 0 or
- •ESR1m detected by central testing of ctDNA
- •Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •Adequate organ and marrow function
排除标准
- •Advanced, symptomatic, visceral spread, that are at risk of lifethreatening complications in the short term
- •Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease.
- •Any evidence of severe or uncontrolled systemic diseases which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.
- •Patient with known or family history of severe heart disease
- •Previous treatment with AZD9833, investigational SERDs or fulvestrant.
- •Currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
- •Persistent non-haematological toxicities (CTCAE Grade > 2) caused by CDK4/6 inhibitor and/or AI treatment.
结局指标
主要结局
Progression-free survival (PFS) is defined as the time from randomisation until progression per RECIST 1.1 as assessed by the investigator at the local site, or death due to any cause.
Progression-free survival (PFS) is defined as the time from randomisation until progression per RECIST 1.1 as assessed by the investigator at the local site, or death due to any cause.
次要结局
- Overall survival (OS)
- Progression-free survival 2 (PFS2)
- Objective response rate (ORR) assessed by the Investigator as defined by RECIST version 1.1
- Chemotherapy-free survival
- Clinical benefit rate at 24 weeks (CBR24)
- Time to first subsequent anti-cancer therapy (TFST)
- Time to second subsequent therapy (TSST)
- Time to deterioration (TTD)
- Plasma concentration of AZD9833 at specified timepoints
- Change from baseline in EORTC QLQ-C30 and EORTC QLQ-BR23 scale
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (108)
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