A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy
Public ClinicalTrials.gov record NCT05646862. 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, Open-Label Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Versus Alpelisib Plus Fulvestrant in Patients With Hormone Receptor-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Who Progressed During or After CDK4/6 Inhibitor and Endocrine Combination Therapy
Study identification
- NCT ID
- NCT05646862
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Hoffmann-La Roche
- Industry
- Enrollment
- 420 participants
Conditions and interventions
Conditions
Interventions
- Alpelisib Drug
- Bupropion Drug
- Fulvestrant Drug
- Inavolisib Drug
- Midazolam Drug
- Omeprazole 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
- Jun 6, 2023
- Primary completion
- Nov 12, 2026
- Completion
- Mar 29, 2029
- Last update posted
- May 5, 2026
2023 – 2029
United States locations
- U.S. sites
- 14
- U.S. states
- 9
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cancer Blood and Specialty Clinic | Los Alamitos | California | 90720 | — |
| Los Angeles Cancer Network | Los Angeles | California | 90017-4803 | — |
| UC Davis Comprehensive Cancer Center | Sacramento | California | 95817 | — |
| Rocky Mountain Cancer Centers | Denver | Colorado | 80220 | — |
| Cleveland Clinic Florida | Weston | Florida | 33331 | — |
| Grady Health System | Atlanta | Georgia | 30303 | — |
| Midtown West Medical | Atlanta | Georgia | 30318 | — |
| Emory University Hospital | Atlanta | Georgia | 30322 | — |
| Winship Cancer Institute at Emory Saint Joseph's Hospital | Atlanta | Georgia | 30342 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Cancer & Hematology Centers of Western Michigan | Grand Rapids | Michigan | 49503 | — |
| Minnesota Oncology Hematology | Saint Paul | Minnesota | 55102 | — |
| Asante Rogue Regional Medical Center | Medford | Oregon | 97504-8332 | — |
| Texas Oncology - Dallas Presbyterian Hospital | Dallas | Texas | 75231 | — |
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 130 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05646862, 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 May 5, 2026 · Synced May 8, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05646862 live on ClinicalTrials.gov.