Clinical trial · no report yet · Phase 3
VIKTORIA-1
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 ↗
- Active not recruiting
- Celcuity Inc
- 195 commentary sources found
- Deep
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Commentary we found
Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.
| Channel | Found | |
|---|---|---|
| X threads | 96 | |
| YouTube | 52 | |
| Podcasts | 43 | |
| X videos | 4 |
The trial
ClinicalTrials.gov- 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
- Phase
- Phase 3
- Status
- Active not recruiting
- Conditions
- Breast Cancer
- Interventions
- Gedatolisib; Palbociclib; Fulvestrant; Alpelisib
- Arms
- Arm A - Patients Lacking PIK3CA Mutations (WT) · Experimental
- Arm B - Patients Lacking PIK3CA Mutations (WT) · Experimental
- Arm C - Patients Lacking PIK3CA Mutations (WT) · Active comparator
- Arm D - Patients with PIK3CA Mutation (MT) · Experimental
- Arm E - Patients with PIK3CA Mutation (MT) · Active comparator
- Arm F - Patients with PIK3CA Mutation (MT) · Experimental
- Enrollment
- 701 (estimated)
- Primary outcomes
- Progression Free Survival (PFS) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
- Sponsor
- Celcuity Inc
- Start
- Dec 8, 2022
- Primary completion
- Jun 30, 2026 (estimated)
- Results posted
- No
- Registry record
- NCT05501886 · updated Feb 10, 2026
Publications
linked from the registry- Hurvitz SA, Layman RM, Curigliano G, Andre F, Cristofanilli M, Kim SB, Martinez Rodriguez JL, Nadal JC, Kim GM, Lo L, Remolina-Bonilla YA, Rosselli G, Emile G, Korbenfeld E, Puig JM, Wesolowski R, Martin M, Ring A, Han HS, Giordano A, Mutka SC, Moss K, Suzuki S, Sullivan B, Gorbatchevsky I, Pistilli B; VIKTORIA-1 Study Group. VIKTORIA-1 Trial of Gedatolisib Plus Fulvestrant With or Without Palbociclib in Hormone Receptor-Positive/HER2-/PIK3CA Wild-Type Advanced Breast Cancer. J Clin Oncol. 2026 Apr 20;44(12):1108-1119. doi: 10.1200/JCO-25-02643. Epub 2026 Mar 9. PubMed 41802242