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RECRUITINGPhase 3INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 advanced breast cancer (ABC).

Who May Be Eligible (Plain English)

Who May Qualify: - Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 - diagnosed by tissue sample (biopsy-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 Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion 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 Exclusion 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

Treatments Being Tested

DRUG

Inavolisib

Participants will receive an inavolisib tablet to be taken orally (PO), once a day (QD), on Days 1-21 of each 21-day cycle, beginning on Day (D) 1 of Cycle (C) 1 of maintenance treatment.

DRUG

Phesgo

Phesgo will be administered to participants subcutaneously every 3 weeks (Q3W) on D1 of each 21-day cycle.

DRUG

Placebo

Inavolisib-matching tablet taken PO QD on Days 1-21 of each 21-day cycle, beginning on D1 C1 of maintenance treatment.

DRUG

Taxane-based Chemotherapy

During the induction therapy phase, the investigator's choice of taxane-based chemotherapy will be administered after Phesgo.

DRUG

Optional Endocrine Therapy of Investigator's Choice

Optional endocrine therapy (ET) is allowed at the discretion of the investigator, based on the standard of care. Allowed ETs are tamoxifen, or one of the specified third-generation aromatase inhibitor (AI \[anastrozole, letrozole, or exemestane\]), or fulvestrant. The investigator will determine and supply the appropriate luteinizing hormone-releasing hormone (LHRH) agonist locally approved for use in breast cancer. The LHRH agonist will be administered according to local prescribing information.

Locations (20)

Banner Health MD Anderson AZ
Gilbert, Arizona, United States
Disney Family Cancer Center
Burbank, California, United States
City of Hope
Corona, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
City of Hope at Irvine Lennar
Irvine, California, United States
Ellison Institute of Technology
Los Angeles, California, United States
Georgetown Uni Hospital
Washington D.C., District of Columbia, United States
Medstar Research Institute
Hyattsville, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Renown Regional Medical Center
Reno, Nevada, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Atrium Health
Charlotte, North Carolina, United States
Hightower Clinical
Oklahoma City, Oklahoma, United States
Renovatio Clinical - El Paso
El Paso, Texas, United States
JPS Health Network
Fort Worth, Texas, United States
Lumi Research
Kingwood, Texas, United States
Renovatio Clinical
The Woodlands, Texas, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States
Swedish Medical Center
Seattle, Washington, United States