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
Public ClinicalTrials.gov record NCT05894239. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT05894239
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 230 participants
Conditions and interventions
Conditions
Interventions
- Inavolisib Drug
- Phesgo Drug
- Placebo Drug
- Taxane-based Chemotherapy Drug
- Optional Endocrine Therapy of Investigator's Choice Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 8, 2023 (Actual)
- Primary completion
- Dec 31, 2026 (Estimated)
- Completion
- Dec 28, 2032 (Estimated)
- Last update posted
- Oct 16, 2026
2023 – 2032
United States locations
- U.S. sites
- 20
- U.S. states
- 12
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner Health MD Anderson AZ | Gilbert | Arizona | 85234 | Recruiting |
| Disney Family Cancer Center | Burbank | California | 91505 | Recruiting |
| City of Hope | Corona | California | 92882 | Recruiting |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | Recruiting |
| City of Hope at Irvine Lennar | Irvine | California | 92618 | Recruiting |
| Ellison Medical Institute | Los Angeles | California | 90064 | Recruiting |
| Georgetown Uni Hospital | Washington D.C. | District of Columbia | 20007 | Recruiting |
| Medstar Research Institute | Hyattsville | Maryland | 20783 | Recruiting |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | Recruiting |
| Henry Ford Hospital | Detroit | Michigan | 48202 | Recruiting |
| Renown Regional Medical Center | Reno | Nevada | 89502 | Withdrawn |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | Withdrawn |
| Atrium Health | Charlotte | North Carolina | 28209 | Recruiting |
| Hightower Clinical | Oklahoma City | Oklahoma | 73102 | Withdrawn |
| Renovatio Clinical - El Paso | El Paso | Texas | 79915 | Recruiting |
| JPS Health Network | Fort Worth | Texas | 76104 | Recruiting |
| Lumi Research | Kingwood | Texas | 77339 | Withdrawn |
| Renovatio Clinical | The Woodlands | Texas | 77380 | Recruiting |
| Kadlec Clinic Hematology and Oncology | Kennewick | Washington | 99336-7774 | Recruiting |
| Swedish Medical Center | Seattle | Washington | 98104-1360 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 172 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05894239, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 16, 2026 · Synced Oct 16, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05894239 live on ClinicalTrials.gov.