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.
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).
| Facility | City | Region | Status |
|---|---|---|---|
| Banner Health MD Anderson AZ | Gilbert | Arizona | Recruiting |
| Disney Family Cancer Center | Burbank | California | Recruiting |
| City of Hope | Corona | California | Recruiting |
| City of Hope Comprehensive Cancer Center | Duarte | California | Recruiting |
| City of Hope at Irvine Lennar | Irvine | California | Recruiting |
| Ellison Medical Institute | Los Angeles | California | Recruiting |
| Georgetown Uni Hospital | Washington D.C. | District of Columbia | Recruiting |
| Medstar Research Institute | Hyattsville | Maryland | Recruiting |
| Dana Farber Cancer Institute | Boston | Massachusetts | Recruiting |
| Henry Ford Hospital | Detroit | Michigan | Recruiting |
| Renown Regional Medical Center | Reno | Nevada | Withdrawn |
| Hackensack University Medical Center | Hackensack | New Jersey | Withdrawn |
| Atrium Health | Charlotte | North Carolina | Recruiting |
| Hightower Clinical | Oklahoma City | Oklahoma | Withdrawn |
| Renovatio Clinical - El Paso | El Paso | Texas | Recruiting |
| JPS Health Network | Fort Worth | Texas | Recruiting |
| Lumi Research | Kingwood | Texas | Withdrawn |
| Renovatio Clinical | The Woodlands | Texas | Recruiting |
| Kadlec Clinic Hematology and Oncology | Kennewick | Washington | Recruiting |
| Swedish Medical Center | Seattle | Washington | Recruiting |
| Centro de Investigaciones Médicas y Desarrollo LC S.R.L | Buenos Aires | Ciudad Autónoma de BuenosAires | Active Not Recruiting |
| Centro Oncologico Korben | Ciudad Autonoma Buenos Aires | Argentina | Active Not Recruiting |
| Instituto de Oncología de Rosario | Rosario | Argentina | Active Not Recruiting |
| Hospital Provincial del Centenario | Rosario | Argentina | Active Not Recruiting |
| CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica | San Juan | Argentina | Active Not Recruiting |
| Clínica Viedma | Viedma Rio Negro | Argentina | Withdrawn |
| Blacktown Hospital | Blacktown | New South Wales | Withdrawn |
| Kinghorn Cancer Centre | Darlinghurst | New South Wales | Withdrawn |
| Gosford Hospital | Gosford | New South Wales | Withdrawn |
| University of the Sunshine Coast | Sippy Downs | Queensland | Withdrawn |
| Monash Health | Clayton | Victoria | Completed |
| Sir Charles Gairdner Hospital | Perth | Western Australia | Completed |
| Institut Jules Bordet | Anderlecht | Belgium | Withdrawn |
| CHIREC | Auderghem | Belgium | Withdrawn |
| CHU Brugmann (Victor Horta) | Brussels | Belgium | Withdrawn |
| Cliniques Universitaires St-Luc | Brussels | Belgium | Withdrawn |
| GHdC Site Les Viviers | Charleroi | Belgium | Withdrawn |
| CHU HELORA - Hôpital de la Louvière - Site Jolimont | Haine-Saint-Paul | Belgium | Active Not Recruiting |
| Jessa Zkh (Campus Virga Jesse) | Hasselt | Belgium | Withdrawn |
| Clinique Ste-Elisabeth | Namur | Belgium | Withdrawn |
+ 152 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05894239 on ClinicalTrials.gov ↗ ← All trials in India