NIPH Clinical Trials Search

A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	PIK3CA-mutated HER2-positive locally advanced or metastatic breast cancer
Date of first enrollment	16/01/2026
Target sample size	230
Countries of recruitment	United States,Japan,Argentina,Japan,Australia,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,China,Japan,Colombia,Japan,Finland,Japan,France,Japan,Germany,Japan,Hong Kong,Japan,India,Japan,Italy,Japan,Jordan,Japan,Kenya,Japan,Mexico,Japan,Oman,Japan,Poland,Japan,Singapore,Japan,South Africa,Japan,South Korea,Japan,Spain,Japan,Taiwan,Japan,Tunisia,Japan,Turkey,Japan,Uganda,Japan,United Kingdom,Japan
Study type	Interventional
Intervention(s)	Inavolisib: Inavolisib will be administered orally 9mg QD. Placebo: Placebo will be administered orally QD. Pertuzumab(Genetical Recombination), Trastuzumab(Genetical Recombination), Vorhyaluronidase Alfa(Genetical Recombination): Administer the standard dose by intravenous injection. Docetaxel Hydrate: Administer the standard dose by intravenous injection. Paclitaxel: Administer the standard dose by intravenous injection.

Outcome(s)

Primary Outcome

efficacy Investigator-Assessed Progression-Free Survival (PFS)

Secondary Outcome

safety, efficacy, phamacokinetics "Overall Survival (OS) Investigator-Assessed Objective Response Rate (ORR) Investigator-Assessed Duration of Response (DOR) Investigator-Assessed Clinical Benefit Rate (CBR) Investigator-Assessed PFS2 Mean and Mean Changes from Baseline Score in Function and Health-Related Quality of Life (HRQoL) Percentage of Participants with Adverse Events Plasma Concentration of Inavolisib at Specified Timepoints

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	-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 >= 6 months -LVEF (left ventricular ejection fraction) of at least 50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) -Adequate hematologic and organ function prior to initiation of study treatment
Exclude criteria	-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 -Participants with active HBV infection -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