Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
Public ClinicalTrials.gov record NCT06757634. 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
VIKTORIA-2: A Randomized, Open-Label, Phase 3 Study of Fulvestrant and CDK4/6 Inhibitors With or Without Gedatolisib as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast Cancer
Study identification
- NCT ID
- NCT06757634
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Celcuity Inc
- Industry
- Enrollment
- 674 participants
Conditions and interventions
Conditions
Interventions
- Arm A: Gedatolisib + Palbociclib or Ribociclib + Fulvestrant Drug
- Arm B: Palbociclib or Ribociclib + Fulvestrant 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
- Jul 23, 2025
- Primary completion
- Dec 30, 2027
- Completion
- Dec 29, 2028
- Last update posted
- Feb 4, 2026
2025 – 2028
United States locations
- U.S. sites
- 22
- U.S. states
- 16
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | Not yet recruiting |
| Providence Medical Foundation | Fullerton | California | 92835 | Recruiting |
| UCLA Hematology Oncology Santa Monica | Los Angeles | California | 90404 | Recruiting |
| BRCR Medical Center, Inc- Internal Medicine | Plantation | Florida | 33322 | Recruiting |
| BRCR Medical Center, INC | Tamarac | Florida | 33321 | Recruiting |
| The University of Kansas Cancer Center | Westwood | Kansas | 66205 | Recruiting |
| Mercy Health-Paducah Cancer Center | Paducah | Kentucky | 42003 | Recruiting |
| American Oncology Partners, P.A. | Bethesda | Maryland | 20817 | Recruiting |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | Not yet recruiting |
| Henry Ford Health System | Detroit | Michigan | 48202 | Recruiting |
| Saint Luke's Cancer Institute | Kansas City | Missouri | 64111-5965 | Recruiting |
| Washington University School of Medicine in Saint Louis | St Louis | Missouri | 63110 | Recruiting |
| SCL Health - Cancer Centers of Montana | Billings | Montana | 59102 | Recruiting |
| Weill Cornell Medical College - NewYork-Presbyterian Hospital | New York | New York | 10065 | Not yet recruiting |
| Clinical Research Alliance, Inc. | Westbury | New York | 11590 | Recruiting |
| Stefanie Spielman Comprehensive Breast Center at Olentangy River Road | Columbus | Ohio | 43210 | Recruiting |
| Rittenhouse Hematology/Oncology | Philadelphia | Pennsylvania | 19004 | Recruiting |
| Sanford Health | Sioux Falls | South Dakota | 57106 | Not yet recruiting |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030-4000 | Recruiting |
| Mays Cancer Center | San Antonio | Texas | 78229 | Recruiting |
| Bon Secours St. Francis Medical Oncology Center | Midlothian | Virginia | 23114-3203 | Recruiting |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | 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 181 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06757634, 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 4, 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 NCT06757634 live on ClinicalTrials.gov.