計劃書編號WO43919
NCT Number(ClinicalTrials.gov Identfier)NCT05646862
試驗執行中
2023-04-01 - 2030-12-31
Phase III
尚未開始1
召募中5
ICD-10C50.911
女性右側乳房未明示部位惡性腫瘤
ICD-10C50.912
左側女性乳房未明示部位惡性腫瘤
ICD-10C50.919
女性乳房未明示部位惡性腫瘤
ICD-10Z51.12
來院接受抗腫瘤免疫療法
ICD-9174.9
女性乳房惡性腫瘤
一項第三期、多中心、隨機分配、開放性試驗，在接受CDK4/6抑制劑和內分泌合併療法期間或之後出現惡化的荷爾蒙受體陽性、HER2陰性、PIK3CA突變、局部晚期或轉移性乳癌病患中評估INAVOLISIB + FULVESTRANT相較於ALPELISIB + FULVESTRANT的療效和安全性
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試驗申請者
羅氏大藥廠股份有限公司
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試驗委託 / 贊助單位名稱
羅氏大藥廠股份有限公司
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臨床試驗規模
多國多中心
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更新日期
2025/11/01
試驗主持人及試驗醫院
實際收案人數
0 召募中
實際收案人數
0 召募中
實際收案人數
0 召募中
實際收案人數
0 召募中
適應症
主要療效目的：無惡化存活期(PFS)
試驗目的
本試驗將評估inavolisib + fulvestrant相較於alpelisib + fulvestrant對於CDK4/6i併用內分泌療法(ET)治療期間或之後出現惡化的HR+/HER2-、PIK3CA突變LA/mBC參與者之療效和安全性
藥品名稱
錠劑
主成份
Inavolisib
Inavolisib
alpelisib
alpelisib
alpelisib
Fulvestrant
Inavolisib
alpelisib
alpelisib
alpelisib
Fulvestrant
劑型
Tablet
Tablet
vial
Tablet
vial
劑量
3mg
9mg
150mg
200mg
50mg
250mg/5ml
9mg
150mg
200mg
50mg
250mg/5ml
評估指標
主要療效目的：無惡化存活期(PFS)
主要納入條件
•已簽署受試者同意書
•簽署受試者同意書時年滿≥ 18歲的女性或男性
•若為女性病患，則必須符合以下至少一項定義：
-停經後，至少符合下列一項標準：
•年齡≥ 60歲
(詳細納入條件可參照計畫書)
•簽署受試者同意書時年滿≥ 18歲的女性或男性
•若為女性病患，則必須符合以下至少一項定義：
-停經後，至少符合下列一項標準：
•年齡≥ 60歲
(詳細納入條件可參照計畫書)
主要排除條件
Exclusion Criteria:
Metaplastic breast cancer
Prior treatment in locally advanced or metastatic setting with any PI3K, AKT, or mTOR inhibitor or any agent whose mechanism of action is to inhibit the PI3K/-AKT/-mTOR pathway
Participant who relapsed with documented evidence of progression > 12 months from completion of adjuvant CDK4/6i based therapy with no treatment for metastatic disease
Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or at least 60 days after the final dose of study treatment
Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
Inability or unwillingness to swallow pills
Malabsorption syndrome or other condition that would interfere with enteral absorption
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 if they meet specific certain criteria
Known active, systemic infection at study enrollment, or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 7 days prior to Day 1 of Cycle 1
Any concurrent ocular or intraocular condition that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition
Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye
Requirement for daily supplemental oxygen
Symptomatic active lung disease, including pneumonitis
History of or active inflammatory bowel disease
Any active bowel inflammation
Clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis
Participants with known human immunodeficiency virus infection that meet specific criteria
Investigational drug(s) within 4 weeks before randomization or within 5 half-lives of the investigational drug(s), whichever is longer
History of other malignancy within 5 years prior to screening, except for cancers with very low risk of recurrence
Chronic therapy of >= 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressants for a chronic disease
Allergy or hypersensitivity to components or excipients of the inavolisib, fulvestrant, or alpelisib formulations
History of severe cutaneous reactions like Stevens-Johnson Syndrome, Erythema Multiforme, Toxic Epidermal Necrolysis, or Drug Reaction with Eosinphilia and Systemic Symptoms
Active ongoing osteonecrosis of the jaw
Metaplastic breast cancer
Prior treatment in locally advanced or metastatic setting with any PI3K, AKT, or mTOR inhibitor or any agent whose mechanism of action is to inhibit the PI3K/-AKT/-mTOR pathway
Participant who relapsed with documented evidence of progression > 12 months from completion of adjuvant CDK4/6i based therapy with no treatment for metastatic disease
Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or at least 60 days after the final dose of study treatment
Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
Inability or unwillingness to swallow pills
Malabsorption syndrome or other condition that would interfere with enteral absorption
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 if they meet specific certain criteria
Known active, systemic infection at study enrollment, or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 7 days prior to Day 1 of Cycle 1
Any concurrent ocular or intraocular condition that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition
Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye
Requirement for daily supplemental oxygen
Symptomatic active lung disease, including pneumonitis
History of or active inflammatory bowel disease
Any active bowel inflammation
Clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis
Participants with known human immunodeficiency virus infection that meet specific criteria
Investigational drug(s) within 4 weeks before randomization or within 5 half-lives of the investigational drug(s), whichever is longer
History of other malignancy within 5 years prior to screening, except for cancers with very low risk of recurrence
Chronic therapy of >= 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressants for a chronic disease
Allergy or hypersensitivity to components or excipients of the inavolisib, fulvestrant, or alpelisib formulations
History of severe cutaneous reactions like Stevens-Johnson Syndrome, Erythema Multiforme, Toxic Epidermal Necrolysis, or Drug Reaction with Eosinphilia and Systemic Symptoms
Active ongoing osteonecrosis of the jaw
試驗計畫預計收納受試者人數
-
台灣人數
60 人
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全球人數
400 人
