2023-505812-39-00招募中3 期
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Patients with PIK3CA -Mutant, Hormone Receptor-Positive, HER2 -Negative Locally Advanced or Metastatic Breast Cancer
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 91
- 试验地点
- 44
- 主要终点
- 1. Progression-free survival
研究概览
简要总结
To evaluate the efficacy of inavolisib plus palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant on the basis of progression-free survival
研究设计
- 分配方式
- Randomized
- 主要目的
- A Phase Iii, Randomized, Double-blind, Placebo-controlled Study
- 盲法
- Double (Investigator, Subject, Carer, Monitor)
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
- •Confirmed diagnosis of HR+/HER2-negative breast cancer
- •Metastatic or Locally Advanced disease not amenable to curative therapy
- •Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test)
- •Progression of disease during adjuvant endocrine treatment or within 12 months of completing adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen
- •Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
排除标准
- •Metaplastic breast cancer
- •Any history of leptomeningeal disease or carcinomatous meningitis
- •Any prior systemic therapy for metastatic breast cancer
- •Prior treatment with fulvestrant or any selective estrogen-receptor degrader, with the exception of patients that have received fulvestrant or any selective estrogen receptor degrader as part of neoadjuvant therapy only and with treatment duration of no longer than 6 months
- •Prior treatment with any PI3K, AKT, or mTOR inhibitor, or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway
- •Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
研究组 & 干预措施
PALBOCICLIB, PALBOCICLIB, PALBOCICLIB
Test
干预措施: PALBOCICLIB (Drug)
INAVOLISIB, INAVOLISIB, INAVOLISIB, INAVOLISIB
Test
干预措施: INAVOLISIB (Drug)
Faslodex 250 mg solution for injection.
Test
干预措施: Faslodex 250 mg solution for injection. (Drug)
结局指标
主要结局
1. Progression-free survival
1. Progression-free survival
次要结局
- 3. Best overall response rate
- 4. Clinical benefit rate
- 5. Duration of response
- 6. Time to confirmed deterioration (TTCD) in pain
- 7. TTCD in physical function
- 8. TTCD in Role Function
- 9. TTCD in GHS/HRQoL
- 16. Plasma concentration of palbociclib at specified timepoints
- 17. Plasma concentration of fulvestrant at specified timepoints
- 1. Overall survival
- 2. Objective response rate
- 10. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
- 11. Change from baseline in targeted vital signs
- 12. Change from baseline in targeted clinical laboratory test results
- 13. Change from baseline in ECG parameters
- 14. Plasma concentration of inavolisib at specified timepoints
- 15. Plasma concentration of inavolisib at additional specified timepoints in patients enrolled in China
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (44)
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