Clinical Trial: NCT05501886
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)
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | Celcuity Inc |
| Information Provided By: | Celcuity Inc |
| Last Update Posted: | 2026-02-10 |
Study Overview
Brief 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.
Official Title
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
Conditions
Breast Cancer
Intervention / Treatment
- Drug: Gedatolisib
- Drug: Palbociclib
- Drug: Fulvestrant
- Drug: Alpelisib
Other Study ID Numbers
- CELC-G-301
- 2021-005235-24
Start Date (Actual)
2022-12-08
Primary Completion Date (Estimated)
2026-06-30
Study Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
701
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Celcuity Inc |
| Information Provided By: | Celcuity Inc |
| Last Update Posted: | 2026-02-10 |
Study Overview
Brief 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.
Official Title
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
Conditions
Breast Cancer
Intervention / Treatment
- Drug: Gedatolisib
- Drug: Palbociclib
- Drug: Fulvestrant
- Drug: Alpelisib
Other Study ID Numbers
- CELC-G-301
- 2021-005235-24
Start Date (Actual)
2022-12-08
Primary Completion Date (Estimated)
2026-06-30
Study Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
701
Study Type
Interventional
Phase
Phase 3