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
NCT05894239
This study is recruiting at 16 US sites in 9 states, according to its ClinicalTrials.gov record last updated .
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).
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Metastatic Breast Cancer
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 3
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Hoffmann-La Roche
- Last updated on ClinicalTrials.gov
- September 21, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Arizona · 1
- Banner Health MD Anderson AZ · Gilbert, AZ
California · 5
- Disney Family Cancer Center · Burbank, CA
- City of Hope · Corona, CA
- City of Hope Comprehensive Cancer Center · Duarte, CA
- City of Hope at Irvine Lennar · Irvine, CA
- Ellison Medical Institute · Los Angeles, CA
District of Columbia · 1
- Georgetown Uni Hospital · Washington D.C., DC
Maryland · 1
- Medstar Research Institute · Hyattsville, MD
Massachusetts · 1
- Dana Farber Cancer Institute · Boston, MA
Michigan · 1
- Henry Ford Hospital · Detroit, MI
North Carolina · 1
- Atrium Health · Charlotte, NC
Texas · 3
- Renovatio Clinical - El Paso · El Paso, TX
- JPS Health Network · Fort Worth, TX
- Renovatio Clinical · The Woodlands, TX
Washington · 2
- Kadlec Clinic Hematology and Oncology · Kennewick, WA
- Swedish Medical Center · Seattle, WA
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.