Recruiting
Phase 3

Inavolisib & Phesgo

Sponsor:

Hoffmann-La Roche

Code:

NCT05894239

Conditions

Metastatic Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Inavolisib

Phesgo

Placebo

Taxane-based Chemotherapy

Optional Endocrine Therapy of Investigator's Choice

Study Details

Brief summary:

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 ID

NCT05894239

Start date

Sep 8, 2023

Status verified date

Aug, 2026

Completion date

Dec 28, 2032

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

230 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Induction Therapy: Phesgo plus Taxane-Based Chemotherapy

Participants will be administered the treatments as outlined in the interventions section.

experimental: Maintenance Therapy: Inavolisib plus Phesgo

Participants will be administered the treatments as outlined in the interventions section.

active comparator: Maintenance Therapy: Placebo plus Phesgo

Participants will be administered the treatments as outlined in the interventions section.

Interventions

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.

Phesgo

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

Placebo

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

Taxane-based Chemotherapy

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

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.

Primary outcome measure

  • Investigator-Assessed Progression-Free Survival (PFS) [ Time Frame: Up to approximately 40 months ]

Central Contacts and Locations

Central contacts

Reference Study ID Number: WO44263 https://forpatients.roche.com/ No attachments to email below.

888-662-6728 (U.S. Only)global-roche-genentech-trials@gene.com

Locations

Banner Health MD Anderson AZ

Recruiting

Gilbert, Arizona, United States, 85234

Disney Family Cancer Center

Recruiting

Burbank, California, United States, 91505

City of Hope

Recruiting

Corona, California, United States, 92882

City of Hope Comprehensive Cancer Center

Recruiting

Duarte, California, United States, 91010

City of Hope at Irvine Lennar

Recruiting

Irvine, California, United States, 92618

Ellison Medical Institute

Recruiting

Los Angeles, California, United States, 90064

Georgetown Uni Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20007

Medstar Research Institute

Recruiting

Hyattsville, Maryland, United States, 20783

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Atrium Health

Recruiting

Charlotte, North Carolina, United States, 28209

Renovatio Clinical - El Paso

Recruiting

El Paso, Texas, United States, 79915

JPS Health Network

Recruiting

Fort Worth, Texas, United States, 76104

Renovatio Clinical

Recruiting

The Woodlands, Texas, United States, 77380

Kadlec Clinic Hematology and Oncology

Recruiting

Kennewick, Washington, United States, 99336-7774

Swedish Medical Center

Recruiting

Seattle, Washington, United States, 98104-1360

Arthur J.E. Child Comprehensive Cancer Center-Calgary

Recruiting

Calgary, Alberta, Canada, T2N 5G2

The Moncton Hospital

Recruiting

Moncton, New Brunswick, Canada, E1C 6Z8

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Hôpital du Sacré-Coeur de Montreal

Recruiting

Montreal, Quebec, Canada, H4J 1C5

Centre Hospitalier de l?Université de Montréal (CHUM)

Recruiting

Montreal, Quebec, Canada, PO 25223

Hopital du Saint Sacrement

Recruiting

Québec, Quebec, Canada, G1S 4L8

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-08-25.