NCT06757634

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

VIKTORIA-2: A Randomized, Open-Label, Phase 3 Study of Fulvestrant and CDK4/6 Inhibitors With or Without Gedatolisib as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 674 (estimated)
• Sponsor: Celcuity Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 3, open-label, randomized clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant combined with a CDK4/6 inhibitor (Investigator's choice of palbociclib or ribociclib) for the treatment of patients with advanced (inoperable) or metastatic hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+/HER2-) breast cancer whose disease has progressed during or within 12 months of adjuvant treatment with endocrine therapy (either an AI or tamoxifen), and who have not received prior systemic therapy for ABC. Gedatolisib is an intravenously administered pan-PI3K/mTOR inhibitor. Palbociclib is a CDK4/6 inhibitor. Fulvestrant is a selective estrogen receptor degrader (SERD). Following completion of the safety run-in phase to determine the gedatolisib dose with ribociclib, subjects will be assigned to 1 of 2 cohorts based on their PIK3CA status and then randomized to either the investigational treatment arm (gedatolisib with fulvestrant and ribociclib or palbociclib) or standard-of-care control arm (fulvestrant and ribociclib or palbociclib).

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Arm A: Gedatolisib + Palbociclib or Ribociclib + Fulvestrant	Drug: Gedatolisib Participants will receive intravenous (IV) gedatolisib once weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off Other Names: • PF-05212384 Drug: Palbociclib Participants will receive oral palbociclib on days 1-21 of each 28-day cycle. Other Names: • IBRANCE Drug: Ribociclib Participants will receive oral ribociclib on Days 1-21 of each 28-day cycle Other Names: • KISQALI® Drug: Fulvestrant Participants will receive intramuscular (IM) fulvestrant every 2 weeks during Cycle 1 and then every 4 weeks Other Names: • Faslodex
DRUG	Arm B: Palbociclib or Ribociclib + Fulvestrant	Drug: Palbociclib Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle Other Names: • IBRANCE Drug: Ribociclib Participants will receive oral ribociclib on Days 1-21 of each 28-day cycle Other Names: • KISQALI® Drug: Fulvestrant Participants will receive intramuscular (IM) fulvestrant approximately every 2 weeks during Cycle 1 then approximately every 4 Other Names: • Faslodex

Timeline

• Start date: 2025-07-24
• Primary completion: 2027-12-31
• Completion: 2028-12-30
• First posted: 2025-01-03
• Last updated: 2026-02-05

Locations

203 sites across 22 countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Czechia, France, Germany, Greece, Hungary, Italy, Malaysia, Mexico, Poland, Portugal, Romania, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study