Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)

ClinicalTrials.gov ID: NCT06757634

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.

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ClinicalTrials.gov public records Last synced May 20, 2026, 1:10 AM EDT

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 Evaluating Efficacy and Safety of Gedatolisib With Endocrine Therapy and Palbociclib vs Endocrine Therapy and Ribociclib 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: 1,180 participants

Conditions and interventions

Conditions

Breast Cancer

Interventions

Arm A: Gedatolisib + Palbociclib + Fulvestrant Drug
Arm B: Ribociclib + Fulvestrant Drug
Arm C: Gedatolisib + Palbociclib + Letrozole Drug
Arm D: Ribociclib + Letrozole 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: Mar 30, 2029
Completion: Jul 29, 2033
Last update posted: May 17, 2026

2025 – 2033

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 May 17, 2026 · Synced May 20, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06757634 live on ClinicalTrials.gov.

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