Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 3 study of Breast Cancer, sponsored by Celcuity.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
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 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 |
What the registry record for NCT05501886 still lists
NCT05501886 is an interventional study that assigns participants to a tested intervention. The registered 701 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 (75% lower).
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 names 20 study sites across 6 states, led by 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.
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 NCT05501886's enrollment target sits among peer trials
701 160th of 1224 higher than 1,065 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
RECRUITING · Phase 3
-
Intensity Modulated Radiotherapy (IMRT) vs. 3D-conformal Accelerated Partial Breast Irradiation (APBI) for Early Stage Breast Cancer After Lumpectomy
RECRUITING · Phase 3
-
A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer
RECRUITING · Phase 3
-
A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment.
RECRUITING · Phase 3
-
A Study of a Comprehensive Prevention Program to Reduce Lymphedema After Axillary Lymph Node Dissection in People With Breast Cancer
RECRUITING · Phase 3
-
Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease
RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06027996 · 702 participants · NA
Melodi Matrix™ in Breast Reconstruction
- NCT00900419 · 700 participants
Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers
- NCT01804686 · 700 participants · Phase 3
A Long-term Extension Study of PCI-32765 (Ibrutinib)
- NCT02107989 · 700 participants
Noninvasive Pre-surgical Evaluation of Patients With Focal Epilepsy and Establishment of a Normative Imaging Database
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI