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)
Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination w/Non-Steroidal Aromatase Inhibitor Therapy
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (235 Sites)
Showing the first 25 of 235 sites.
- University of Alabama at Birmingham — Birmingham, Alabama
- Arizona Oncology (US Oncology/McKesson) - Goodyear — Goodyear, Arizona
- St. Bernards Medical Center — Jonesboro, Arkansas
- CARTI Cancer Center — Little Rock, Arkansas
- Pacific Cancer Medical Center Inc — Anaheim, California
- Kaiser Permanente South Bay Medical Center — Harbor City, California
- Cancer and Blood Specialty Clinic — Los Alamitos, California
- Pacific Cancer Care — Monterey, California
- University of California, Irvine Medical Center — Orange, California
- Ventura County Hematology Oncology Specialists — Oxnard, California
- Redlands Hematology Oncology — Redlands, California
- UCLA Hematology/Oncology-Santa Monica — Santa Monica, California
- Torrance Memorial Physician Network - Cancer Care — Torrance, California
- Kaiser Permanente Medical Center - Vallejo — Vallejo, California
- PIH Health Hospital Whittier — Whittier, California
- Yale Cancer Center - New Haven — New Haven, Connecticut
- South Broward Hospital District d/b/a Memorial Healthcare System — Hollywood, Florida
- Cancer Specialists of North Florida - Jacksonville — Jacksonville, Florida
- H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida
- Bond & Steele Clinic, P.A. d/b/a Bond Clinic, P.A. — Winter Haven, Florida
- John D. Archbold Memorial Hospital — Thomasville, Georgia
- Illinois Cancer Specialists - Arlington Heights — Arlington Heights, Illinois
- Fort Wayne Medical Oncology and Hematology — Fort Wayne, Indiana
- University of Kansas Cancer Center — Westwood, Kansas
- University of Kentucky Medical Center — Lexington, Kentucky
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.