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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)
NCT05501886 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05501886
The ClinicalTrials.gov registry entry for NCT05501886 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 701 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celcuity, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05501886 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05501886?
The interventions under investigation include: Fulvestrant (DRUG), Palbociclib (DRUG), Alpelisib (DRUG), Gedatolisib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05501886?
This trial is sponsored by Celcuity, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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