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NCT06757634Phase 3RECRUITING

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

Study 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.

Conditions
Breast Cancer
Interventions / Drugs
Arm A: Gedatolisib + Palbociclib or Ribociclib + FulvestrantArm B: Palbociclib or Ribociclib + Fulvestrant
View on ClinicalTrials.gov ↗
Sponsor
CELC
Celcuity Inc
Oncology
C58/100
Study Details
Enrollment674 participants
Primary Completion—
Lead SponsorCelcuity Inc
Data Retrieved2026-04-11 04:09:11.213897+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.

Enrolled: 674 participants
Sponsor Catalyst Profile

Celcuity Inc (CELC) is the sponsoring company for this trial. BiotechSign currently grades this company C (58/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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