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Phase III: Inavolisib in Breast Cancer (INAVO122)

Clinical Trial Overview

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

Objective

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 PIK3CA mutated HER2-positive advanced breast cancer (ABC).

Trial Design

Patients can be evaluated or referred for evaluation at any point prior to maintenance therapy

ABC, advanced breast cancer; CBR, clinical benefit rate; CR, complete response; DoR, duration of response; HER2, human epidermal growth factor receptor 2; HR, hormone receptor; mut, mutated; ORR, objective response rate; OS, overall survival; PD, disease progression; PFS, progression-free survival; PFS2, progression-free survival on next line therapy; PH, PERJETA–Herceptin; PHESGO, pertuzumab, trastuzumab, and hyaluronidase-zzxf; PIK3CA, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha; PK, pharmacokinetics; PR, partial response; PROs, patient-reported outcomes; SD, stable disease; SoC, standard of care

Primary Endpoints

Investigator-Assessed Progression-Free Survival (PFS)

Secondary Endpoints

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

Inavolisib

Other names: GDC-0077, RG6114
Modality: Phosphoinositide 3-kinase (PI3K) inhibitor

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Clinical Trial Overview

Inclusion and Exclusion Criteria

Enrollment and Resources

View on ClinicalTrials.gov

Inclusion and Exclusion Criteria

Key Inclusion Criteria

Key Exclusion Criteria

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
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

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

Trial Handout

Enrollment & Resources

Enrollment

For more information on eligibility criteria, view the study or reach out to our team.

Web

ClinicalTrials.gov
Identifier: NCT05894239

Phone

1-888-662-6728
(US and Canada)

Email

[email protected]

Clinical Trial Site Locations

Clinical Trial Site Locations

For more information on recruitment status, or where the study is being conducted

Visit ClinicalTrials.gov

Information is consistent with ClinicalTrials.gov as of July 18, 2025. Products under investigation have not been approved for use outside of the clinical trial setting. This information is presented only for the purposes of providing an overview of clinical trials and should not be construed as a recommendation for use of any product for unapproved purposes.

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ABC
advanced breast cancer
CBR
clinical benefit rate
CR
complete response
DoR
duration of response
HER2
human epidermal growth factor receptor 2
HR
hormone receptor
mut
mutated
ORR
objective response rate
OS
overall survival
PD
disease progression
PFS
progression-free survival
PIK3CA
phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha
PK
pharmacokinetics
PR
partial response
PROs
patient-reported outcomes
SD
stable disease
SoC
standard of care