ClinicalTrials.gov record
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)
ClinicalTrials.gov ID: NCT05501886
Public ClinicalTrials.gov record NCT05501886. 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
Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination w/Non-Steroidal Aromatase Inhibitor Therapy
Study identification
- NCT ID
- NCT05501886
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Celcuity Inc
- Industry
- Enrollment
- 701 participants
Conditions and interventions
Conditions
Interventions
- Gedatolisib Drug
- Palbociclib Drug
- Fulvestrant Drug
- Alpelisib 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
- Dec 7, 2022
- Primary completion
- Jun 29, 2026
- Completion
- Dec 30, 2026
- Last update posted
- Feb 9, 2026
2022 – 2026
United States locations
- U.S. sites
- 71
- U.S. states
- 26
- U.S. cities
- 65
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Arizona Oncology (US Oncology/McKesson) - Goodyear | Goodyear | Arizona | 85395 | — |
| St. Bernards Medical Center | Jonesboro | Arkansas | 72401 | — |
| CARTI Cancer Center | Little Rock | Arkansas | 72205 | — |
| Pacific Cancer Medical Center Inc | Anaheim | California | 92801 | — |
| Kaiser Permanente South Bay Medical Center | Harbor City | California | 90710 | — |
| Cancer and Blood Specialty Clinic | Los Alamitos | California | 90720 | — |
| Pacific Cancer Care | Monterey | California | 93940 | — |
| University of California, Irvine Medical Center | Orange | California | 92868 | — |
| Ventura County Hematology Oncology Specialists | Oxnard | California | 93030 | — |
| Redlands Hematology Oncology | Redlands | California | 92373 | — |
| UCLA Hematology/Oncology-Santa Monica | Santa Monica | California | 90904 | — |
| Torrance Memorial Physician Network - Cancer Care | Torrance | California | 90505 | — |
| Kaiser Permanente Medical Center - Vallejo | Vallejo | California | 94589 | — |
| PIH Health Hospital Whittier | Whittier | California | 90602-1006 | — |
| Yale Cancer Center - New Haven | New Haven | Connecticut | 06520-8028 | — |
| South Broward Hospital District d/b/a Memorial Healthcare System | Hollywood | Florida | 33021 | — |
| Cancer Specialists of North Florida - Jacksonville | Jacksonville | Florida | 32256 | — |
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | — |
| Bond & Steele Clinic, P.A. d/b/a Bond Clinic, P.A. | Winter Haven | Florida | 33881 | — |
| John D. Archbold Memorial Hospital | Thomasville | Georgia | 31792 | — |
| Illinois Cancer Specialists - Arlington Heights | Arlington Heights | Illinois | 60005 | — |
| Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana | 46845 | — |
| University of Kansas Cancer Center | Westwood | Kansas | 66205 | — |
| University of Kentucky Medical Center | Lexington | Kentucky | 40536-0293 | — |
| Mercy Health - Paducah | Paducah | Kentucky | 42003 | — |
| American Oncology Partners of Maryland, PA | Bethesda | Maryland | 20817-7847 | — |
| Maryland Oncology Hematology, P.A. - Rockville | Rockville | Maryland | 20850 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215-5450 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Nebraska Hematology - Oncology, P.C. | Lincoln | Nebraska | 68506 | — |
| Oncology Hematology West PC dba Nebraska Cancer Specialists | Omaha | Nebraska | 68130 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| New York Oncology Hematology, P.C. - Albany | Albany | New York | 12206 | — |
| Queens Hospital Cancer Center | Jamaica | New York | 11432 | — |
| Coleman, Pasmantier & Decter, MDs | New York | New York | 10021-5302 | — |
| Weill Cornell Medicine/New York-Presbyterian Hospital | New York | New York | 10021 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Hematology/Oncology Associates of Central New York | Syracuse | New York | 13057 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| White Plains Hospital | White Plains | New York | 10601 | — |
| Cone Health Cancer Center at Alamance Regional, Hematology/Oncology | Greensboro | North Carolina | 27403 | — |
| Southeast Regional Cancer Center | Lumberton | North Carolina | 28359 | — |
| Sanford Health- Fargo | Fargo | North Dakota | 58102 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106-1716 | — |
| The James Cancer Hospital and Solove Research Institute | Columbus | Ohio | 43210 | — |
| OU Health Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | — |
| Oregon Oncology Specialists | Salem | Oregon | 97301 | — |
| Northwest Cancer Specialists, PC - Tigard | Tigard | Oregon | 97223 | — |
| Consultants In Medical Oncology and Hematology, P.C. | Broomall | Pennsylvania | 19008 | — |
| Alliance Cancer Specialists PC | Horsham | Pennsylvania | 19044 | — |
| Cancer Care Associates of York | York | Pennsylvania | 17403 | — |
| Sanford Gynecologic Oncology Clinic | Sioux Falls | South Dakota | 57104 | — |
| Texas Oncology - Austin | Austin | Texas | 78745 | — |
| Texas Oncology P.A. - Dallas | Dallas | Texas | 75230 | — |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | — |
| William Beaumont Army Medical Center | El Paso | Texas | 79920 | — |
| Oncology Consultants | Houston | Texas | 77030 | — |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Brooke Army Medical Center | Houston | Texas | 78234 | — |
| Texas Oncology - McKinney | McKinney | Texas | 75071 | — |
| Texas Oncology - Gulf Coast | Sugar Land | Texas | 77479 | — |
| Texas Oncology - Tyler | Tyler | Texas | 75702 | — |
| Fort Belvoir Community Hospital | Fort Belvoir | Virginia | 22060 | — |
| Bon Secours St. Francis Medical Oncology Center | Midlothian | Virginia | 23114 | — |
| Virginia Oncology Associates - Newport News | Newport News | Virginia | 23502 | — |
| VCU Massey Cancer Center | Richmond | Virginia | 23219 | — |
| Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care - Roanoke | Roanoke | Virginia | 24014 | — |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109-1023 | — |
| Northwest Medical Specialties, PLLC - Tacoma | Tacoma | Washington | 98405 | — |
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 164 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05501886, 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 Feb 9, 2026 · Synced Jul 22, 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 NCT05501886 live on ClinicalTrials.gov.