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NCT05646862 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Breast Cancer, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 3
- Development phase
- 420
- Enrollment target
- 20
- Study locations
NCT05646862: Active Phase 3 study of Breast Cancer, sponsored by Hoffmann-La Roche.
NCT05646862 is a Phase 3 study of Breast Cancer that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 420 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05646862, a Phase 3 study of Breast Cancer, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 420 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) -negative, PIK3CA-mutated, locally advanced (LA) or metastatic breast cancer (mBC), who progressed during or after cyclin dependent kinase 4/6i (CDK4/6i)-based therapy.
Conditions Studied
Interventions
- DRUG Fulvestrant
- DRUG Inavolisib
- DRUG Omeprazole
- DRUG Alpelisib
- DRUG Bupropion
Study Locations (20)
Other
- Centro de Investigaciones Médicas y Desarrollo LC S.R.L - Buenos Aires
- Centro Oncologico Korben - Ciudad Autonoma Buenos Aires
- Fundacion CORI para la Investigacion y Prevencion del Cancer - La Rioja
- Instituto de Oncología de Rosario - Rosario
- Hosp Provincial D. Centenarios - Rosario
- CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica - San Juan
Georgia
- Grady Health System - Atlanta
- Midtown West Medical - Atlanta
- Emory University Hospital - Atlanta
- Winship Cancer Institute at Emory Saint Joseph's Hospital - Atlanta
California
- Cancer Blood and Specialty Clinic - Los Alamitos
- Los Angeles Cancer Network - Los Angeles
- UC Davis Comprehensive Cancer Center - Sacramento
Colorado
- Rocky Mountain Cancer Centers - Denver
Florida
- Cleveland Clinic Florida - Weston
Massachusetts
- Massachusetts General Hospital - Boston
Michigan
- Cancer & Hematology Centers of Western Michigan - Grand Rapids
Minnesota
- Minnesota Oncology Hematology - Saint Paul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2023-06-07 |
| Est. Completion | 2029-03-30 |
| Phase | Phase 3 |
What the registry record for NCT05646862 still lists
NCT05646862 is an interventional study that assigns participants to a tested intervention. The registered 420 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Fulvestrant is the first listed.
NCT05646862 names 20 study sites across 10 states, led by Other, Georgia, California.
Frequently Asked Questions
What is clinical trial NCT05646862 about?
NCT05646862 is a clinical study titled "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". This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) -negative, PIK3...
What is the current status of trial NCT05646862?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 420 participants. The study started on 2023-06-07. Estimated completion is 2029-03-30.
What conditions does trial NCT05646862 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT05646862?
The interventions under investigation include: Fulvestrant (DRUG), Inavolisib (DRUG), Omeprazole (DRUG), Alpelisib (DRUG), Bupropion (DRUG).
Who is sponsoring clinical trial NCT05646862?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05646862 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05646862's enrollment target sits among peer trials
420 222nd of 1224 higher than 1,002 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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