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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 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 701

Last updated 2026-02-10

No results posted yet for this 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

Interventions

DRUG

Gedatolisib

Gedatolisib 180 mg IV given weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off

DRUG

Palbociclib

Palbociclib 125 mg PO given daily for 3 weeks (21 days), followed by 1 week off

DRUG

Fulvestrant

Fulvestrant 500 mg IM (2 × 5 mL injections) given every 2 weeks during Cycle 1 (Days 1 and 15), then every 4 weeks beginning with Cycle 2 Day 1

DRUG

Alpelisib

Alpelisib 300 mg PO (2 × 150 mg tablets) given daily for 4 weeks (28 days)

Sponsors & Collaborators

  • Celcuity Inc

    lead INDUSTRY

Principal Investigators

  • Nadene Zack · Celcuity Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-08
Primary Completion
2026-06-30
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Czechia
  • France
  • Germany
  • Greece
  • Hungary
  • India
  • Italy
  • Mexico
  • Poland
  • Romania
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05501886 on ClinicalTrials.gov