NCT07748208尚未招募2 期
A Phase II Prospective, Open-Label Safety Study of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With PIK3CA-Mutated Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer and Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Percentage of Participants with AEs After Cycle 1
研究概览
简要总结
This study will evaluate the safety of inavolisib in combination with fulvestrant, with or without palbociclib, in participants with PIK3CA-mutated, HR+, HER2-negative ABC and type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes with laboratory fasting blood glucose < 185 milligrams per deciliter (mg/dL) and HbA1c <= 8% on any stable anti-hyperglycemic regimen excluding insulin short-term insulin dosing
- •Eligible for triplet of inavolisib, fulvestrant and palbociclib: no prior systemic therapy for locally advanced unresectable or metastatic disease
- •Confirmed diagnosis of HR+/HER2- breast cancer
- •Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test)
- •Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- •Adequate hematologic and organ function within 14 days prior to initiation of study treatment
排除标准
- •Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
- •Metaplastic breast cancer
- •Any history of Type 1 diabetes
- •Severe hyper- or hypoglycemia event within 6 months of initiation of study treatment
- •Any history of leptomeningeal disease or carcinomatous meningitis
- •Known and untreated, or active central nervous system (CNS) metastases Participants with a history of treated CNS metastases are eligible
- •Active inflammatory or conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye
- •Symptomatic active lung disease
- •History of active bowel inflammation or active inflammatory bowel disease
研究组 & 干预措施
Inavolisib + Fulvestrant + Palbociclib
Experimental
Participants will receive inavolisib and fulvestrant (and some participants palbociclib) as outlined in the intervention section.
干预措施: Inavolisib (Drug)
Inavolisib + Fulvestrant + Palbociclib
Experimental
Participants will receive inavolisib and fulvestrant (and some participants palbociclib) as outlined in the intervention section.
干预措施: Fulvestrant (Drug)
Inavolisib + Fulvestrant + Palbociclib
Experimental
Participants will receive inavolisib and fulvestrant (and some participants palbociclib) as outlined in the intervention section.
干预措施: Palbociclib (Drug)
结局指标
主要结局
Percentage of Participants with AEs After Cycle 1
时间窗: Up to approximately 21 months
Percentage of Participants With Grade 4 Hyperglycemia Adverse Events (AEs) After Cycle 1
时间窗: Up to approximately 21 months
Percentage of Participants Hospitalized for Hyperglycemia or its Complications After Cycle 1
时间窗: Up to approximately 21 months
次要结局
- Percentage of Particiants With Inavolisib-related Hyperglycemia AEs After Cycle 1(Up to Cycle 1 (each cycle is 28 days))
- Percentage of Participants With Inavolisib Discontinuations due to Hyperglycemia and its Complications(Up to approximately 21 months)
- Percentage of Participants With Inavolisib Dose Reduction due to Hyperglycemia(Up to approximately 21 months)
- Percentage of Participants With Return of Hemoglobin A1c or Glycated Hemoglobin (HbA1c) to Within 10% of Baseline Within 90 Days After Inavolisib Discontinuation(Up to approximately 21 months)
- Number of Participants Reporting Presence,Frequency,Severity,&/or Degree of Interference with Daily Function of Selected Symptomatic Treatment Toxicities Assessed by NCI Patient-Reported Outcomes Common Terminology Criteria for AEs (PRO-CTCAE)(Up to approximately 21 months)
- Percentage of Participants Reporting Each Response Option at Each Time Point for the Treatment Side-Effect Bother Item (GP5) From the Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire(Up to approximately 21 months)
- Change from Baseline in Symptomatic Treatment-Related Toxicities as Assessed Through use of the PRO-CTCAE(Baseline, Up to approximately 21 months)
- Change from Baseline in Treatment Side-Effect Bother as Assessed Through use of the FACT-G General Population, Question 5 (GP5) Item(Baseline, Up to approximately 21 months)
- Objective Response Rate (ORR)(Up to approximately 21 months)
- Best Overall Response Rate (BOR)(Up to approximately 21 months)
- Duration of Response (DOR)(Up to approximately 21 months)
- Progression-Free Survival (PFS)(Up to approximately 21 months)
- Overall Survival (OS)(Up to approximately 21 months)
- Mean and Mean Change From Baseline in Physical Function Score as Assessed by European Organisation for Research and Treatment of Cancer Item Library 17 (EORTC-IL17)(Baseline, up to approximately 21 months)
- Mean and Mean Change From Baseline in Role Function Score as Assessed by EORTC-IL17(Baseline, up to approximately 21 months)
- Mean and Mean Change From Baseline in Health-Related Quality of Life (HRQoL) Score as Assessed by EORTC-IL17(Baseline, up to approximately 21 months)
研究者
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