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NCT06757634 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
A Phase 3 study of Breast Cancer, sponsored by Celcuity.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 674
- Enrollment target
- 20
- Study locations
NCT06757634: Recruiting Phase 3 study of Breast Cancer, sponsored by Celcuity.
NCT06757634 is a Phase 3 study of Breast Cancer that is actively recruiting participants, run by Celcuity. The registered enrollment target is 674 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (76% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06757634, a Phase 3 study of Breast Cancer, is actively recruiting participants, sponsored by Celcuity.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 674 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 and CDK4/6 Inhibitors for the treatment of patients with locally advanced or metastatic HR+/HER2- advanced breast cancer.
Primary Outcome
PFS is defined as the time from randomization to death or the first documented progression, whichever occurs first, confirmed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, as determined based on blinded independent central review (BICR)
Conditions Studied
Interventions
- DRUG Arm A: Gedatolisib + Palbociclib or Ribociclib + Fulvestrant
- DRUG Arm B: Palbociclib or Ribociclib + Fulvestrant
Study Locations (20)
California
- City of Hope Medical Center - Duarte
- Providence Medical Foundation - Fullerton
- UCLA Hematology Oncology Santa Monica - Los Angeles
Florida
- BRCR Medical Center, Inc- Internal Medicine - Plantation
- BRCR Medical Center, INC - Tamarac
Missouri
- Saint Luke's Cancer Institute - Kansas City
- Washington University School of Medicine in Saint Louis - St Louis
New York
- Weill Cornell Medical College - NewYork-Presbyterian Hospital - New York
- Clinical Research Alliance, Inc. - Westbury
Texas
- University of Texas MD Anderson Cancer Center - Houston
- Mays Cancer Center - San Antonio
Kansas
- The University of Kansas Cancer Center - Westwood
Kentucky
- Mercy Health-Paducah Cancer Center - Paducah
Maryland
- American Oncology Partners, P.A. - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 674 participants |
| Start Date | 2025-07-24 |
| Est. Completion | 2028-12-30 |
| Phase | Phase 3 |
What NCT06757634 shows while recruiting
NCT06757634 is an interventional study that assigns participants to a tested intervention. The registered 674 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 (76% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Arm A: Gedatolisib + Palbociclib or Ribociclib + Fulvestrant is the first listed.
NCT06757634 names 20 study sites across 14 states, led by California, Florida, Missouri.
Frequently Asked Questions
What is clinical trial NCT06757634 about?
NCT06757634 is a clinical study titled "Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)". This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant and CDK4/6 Inhibitors for the treatment of patients with locally advanced or metastatic HR+/HER2- advanced breast cancer.
What is the current status of trial NCT06757634?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 674 participants. The study started on 2025-07-24. Estimated completion is 2028-12-30.
What conditions does trial NCT06757634 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT06757634?
The interventions under investigation include: Arm A: Gedatolisib + Palbociclib or Ribociclib + Fulvestrant (DRUG), Arm B: Palbociclib or Ribociclib + Fulvestrant (DRUG).
Who is sponsoring clinical trial NCT06757634?
This trial is sponsored by Celcuity, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06757634 being conducted?
This trial has 20 study locations across California, Florida, Kansas, Kentucky, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
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 NCT06757634's enrollment target sits among peer trials
674 165th of 1224 higher than 1,060 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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