CTRI/2024/03/063812招募中3 期
A Phase III, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of Inavolisib in combination with Phesgo versus placebo in combination with Phesgo as maintenance therapy after first line induction therapy in participants with PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer
F HoffmannLa Roche Ltd8 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2024年4月1日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 230
- 试验地点
- 8
- 主要终点
- Investigator-Assessed Progression-Free Survival (PFS)
研究概览
简要总结
WO44263 (INAVO122) study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC), aged more than 18 years. This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive ABC.The investigational medicinal products (IMP) for this study are Phesgo, inavolisib, and placebo. Taxane, ET, LHRHa, dexamethasone mouth rinse (if available locally), and anti-hyperglycemics such as metformin are considered noninvestigational medicinal products (NIMP).Treatment will continue until disease progression per RECIST v1.1, unacceptable toxicity, death, withdrawal of consent, or study termination by the Sponsor. The total duration of study participation for the first individual randomized can range from 1 day to 111 months, for the last individual randomized it can range from 1 day to 74 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- •Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection
- •Confirmation of HER2 biomarker eligibility based on valid results from central testing of tumor tissue documenting HER2-positivity
- •Confirmation of PIK3CA mutation biomarker eligibility based on valid results from central testing of tumor tissue documenting PIK3CA mutated tumor status
- •Disease free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of more than equal to 6 months
- •LVEF (left ventricular ejection fraction) of at least 50 percent measured by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA)
- •Adequate hematologic and organ function prior to initiation of study treatment
- •Negative hepatitis B surface antigen (HBsAg) test and negative total hepatitis B core antibody (HBcAb) at screening
- •Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative (per local laboratory definition) hepatitis B virus (HBV) DNA test at screening
- •Negative hepatitis C virus (HCV) antibody test at screening, or a positive HCV antibody test followed by a negative HCV RNA test at screening.
排除标准
- •Prior treatment in the 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
- •Any prior systemic non-hormonal anti-cancer therapy for locally advanced or metastatic HER2-positive breast cancer prior to initiation of induction therapy
- •History or active inflammatory bowel disease
- •Disease progression within 6 months of receiving any HER2-targeted therapy
- •Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
- •Clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis Symptomatic active lung disease, including pneumonitis or interstitial lung disease
- •Any history of leptomeningeal disease or carcinomatous meningitis Serious infection requiring IV antibiotics 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
- •Inability or unwillingness to swallow pills.
- •History of malignancy within 5 years prior to screening, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.
- •The medical monitor may be consulted if required
- •History of prior significant toxicity related to trastuzumab or pertuzumab requiring discontinuation of treatment
- •Major surgical procedure, or significant traumatic injury, within 28 days prior to start of study treatment or anticipation of the need for major surgery during the course of study treatment.
结局指标
主要结局
Investigator-Assessed Progression-Free Survival (PFS)
时间窗: Primary PFS analysis: | -Up to approximately 40 months from first patient in (FPI)
次要结局
- Percentage of Participants with Adverse Events(Day 1 until 30 days after the final dose of study treatment (up to approximately 111 months). Each cycle is 21 days.)
- Overall Survival (OS)(Up to approximately 111 months)
- Investigator-Assessed Objective Response Rate (ORR)(Up to approximately 111 months)
- Investigator-Assessed Clinical Benefit Rate (CBR)(Up to approximately 111 months)
- Investigator-Assessed PFS2(Up to approximately 111 months)
- Mean and Mean Changes from Baseline Score in Function and Health-Related Quality of Life (HRQoL)(Day 1 of Cycles 1 and 2 and beyond, 30-day safety follow up visit, post-treatment tumor assessment follow-up with PRO collection and survival follow up visit every 6 months (up to 111 months). Each cycle is 21 days.)
- Plasma Concentration of Inavolisib at Specified Timepoints(Day 1 of Cycles 1 and 4. Each cycle is 21 days.)
研究者
Dr Kaushal Patel
Sunshine Global Hospital
研究点 (8)
Loading locations...
相似试验
撤回
2 期
A Study to Evaluate the Efficacy and Safety of Inavolisib When Administered in Combination With Bevacizumab and FOLFOX or FOLFIRI as First Line Therapy in Participants With Colorectal CancerColorectal CancerNCT07323576Hoffmann-La Roche164
招募中
2 期
To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast CancerBreast CancerNCT07368998Hoffmann-La Roche80
招募中
2 期
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate CancerNCT07287150Hoffmann-La Roche100
尚未招募
2 期
A Study to Test Inavolisib Treatments in Patients with Early-Stage, PIK3CA-Mutated Breast Cancer2024-518811-20-00F. Hoffmann-La Roche AG16
招募中
3 期
A Study Evaluating the Efficacy and Safety of Inavolisib Plus Palbociclib and Fulvestrant versus Placebo Plus Palbociclib and Fulvestrant in Patients with PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer2023-505812-39-00F. Hoffmann-La Roche AG91