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NCT05501886 · ClinicalTrials.gov registry record · Phase 3
Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)
A Phase 3 study of Breast Cancer, sponsored by Celcuity.
- Active
- Registry status
- Phase 3
- Development phase
- 701
- Enrollment target
- 20
- Study locations
NCT05501886 is a Phase 3 study of Breast Cancer that is active but no longer recruiting, run by Celcuity. The registered enrollment target is 701 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (75% lower). The trial reports 20 study locations across 6 states.
The verdict
NCT05501886, a Phase 3 study of Breast Cancer, is active but no longer recruiting, sponsored by Celcuity.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 701 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy.
Conditions Studied
Interventions
- DRUG Fulvestrant
- DRUG Palbociclib
- DRUG Alpelisib
- DRUG Gedatolisib
Study Locations (20)
California
- Pacific Cancer Medical Center Inc - Anaheim
- Kaiser Permanente South Bay Medical Center - Harbor City
- Cancer and Blood Specialty Clinic - Los Alamitos
- Pacific Cancer Care - Monterey
- University of California, Irvine Medical Center - Orange
- Ventura County Hematology Oncology Specialists - Oxnard
- Redlands Hematology Oncology - Redlands
- UCLA Hematology/Oncology-Santa Monica - Santa Monica
- Torrance Memorial Physician Network - Cancer Care - Torrance
- Kaiser Permanente Medical Center - Vallejo - Vallejo
- PIH Health Hospital Whittier - Whittier
Florida
- South Broward Hospital District d/b/a Memorial Healthcare System - Hollywood
- Cancer Specialists of North Florida - Jacksonville - Jacksonville
- H. Lee Moffitt Cancer Center & Research Institute - Tampa
- Bond & Steele Clinic, P.A. d/b/a Bond Clinic, P.A. - Winter Haven
Arkansas
- St. Bernards Medical Center - Jonesboro
- CARTI Cancer Center - Little Rock
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- Arizona Oncology (US Oncology/McKesson) - Goodyear - Goodyear
Connecticut
- Yale Cancer Center - New Haven - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 701 participants |
| Start Date | 2022-12-08 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05501886
The ClinicalTrials.gov registry entry for NCT05501886 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 701 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (75% lower). The listed sponsor is Celcuity, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Fulvestrant is the first listed.
NCT05501886 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Florida, Arkansas.
Frequently Asked Questions
What is clinical trial NCT05501886 about?
NCT05501886 is a clinical study titled "Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)". This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase in...
What is the current status of trial NCT05501886?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 701 participants. The study started on 2022-12-08. Estimated completion is 2026-12-31.
What conditions does trial NCT05501886 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT05501886?
The interventions under investigation include: Fulvestrant (DRUG), Palbociclib (DRUG), Alpelisib (DRUG), Gedatolisib (DRUG).
Who is sponsoring clinical trial NCT05501886?
This trial is sponsored by Celcuity, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05501886 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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