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

Description

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).

Conditions

Metastatic Breast Cancer

Study Overview

Study Details

Study overview

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).

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

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

Condition
Metastatic Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Gilbert

Banner Health MD Anderson AZ, Gilbert, Arizona, United States, 85234

Burbank

Disney Family Cancer Center, Burbank, California, United States, 91505

Los Angeles

Lawrence J. Ellison Institute for Transformative Medicine, Los Angeles, California, United States, 90064

Washington

Georgetown Uni Hospital; 4-N Main Hospital, Washington, District of Columbia, United States, 20007

Hyattsville

Medstar Research Institute, Hyattsville, Maryland, United States, 20783

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Detroit

Henry Ford Hospital, Detroit, Michigan, United States, 48202

Reno

Renown Regional Medical Center, Reno, Nevada, United States, 89502

Hackensack

Hackensack University Medical Center, Hackensack, New Jersey, United States, 07601

Charlotte

Atrium Health, Charlotte, North Carolina, United States, 28209

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Hoffmann-La Roche,

Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

2028-01-28