← Back to Search

Estrogen Receptor Antagonist

Gedatolisib + Fulvestrant ± Palbociclib for Breast Cancer(VIKTORIA-1 Trial)

Infanta Cristina Hospital, Badajoz, Spain
Gedatolisib +3 morePhase 3RecruitingResearch Sponsored by Celcuity, Inc.

VIKTORIA-1 Trial Summary

This trial tests a combination of drugs to treat advanced breast cancer after other treatments have stopped working.

Eligible Conditions
  • Breast Cancer

VIKTORIA-1 Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

VIKTORIA-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival (PFS) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Secondary outcome measures
Adverse Events
Clinical Benefit Rate (CBR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Duration of Response (DOR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

VIKTORIA-1 Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: Arm F - Patients with PIK3CA Mutation (MT)Experimental Treatment2 Interventions
Gedatolisib + Fulvestrant
Group II: Arm D - Patients with PIK3CA Mutation (MT)Experimental Treatment3 Interventions
Gedatolisib + Palbociclib + Fulvestrant
Group III: Arm B - Patients Lacking PIK3CA Mutations (WT)Experimental Treatment2 Interventions
Gedatolisib + Fulvestrant
Group IV: Arm A - Patients Lacking PIK3CA Mutations (WT)Experimental Treatment3 Interventions
Gedatolisib + Palbociclib + Fulvestrant
Group V: Arm C - Patients Lacking PIK3CA Mutations (WT)Active Control1 Intervention
Fulvestrant
Group VI: Arm E - Patients with PIK3CA Mutation (MT)Active Control2 Interventions
Alpelisib + Fulvestrant
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gedatolisib
2018
Completed Phase 1
~160
Palbociclib
2017
Completed Phase 3
~3720
Fulvestrant
2011
Completed Phase 3
~3700

Find a Location

Who is running the clinical trial?

Celcuity, Inc.Lead Sponsor
6 Previous Clinical Trials
261 Total Patients Enrolled
2 Trials studying Breast Cancer
197 Patients Enrolled for Breast Cancer
Nadene ZackStudy DirectorCelcuity, Inc.

Media Library

Fulvestrant (Estrogen Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05501886 — Phase 3
Breast Cancer Research Study Groups: Arm F - Patients with PIK3CA Mutation (MT), Arm A - Patients Lacking PIK3CA Mutations (WT), Arm B - Patients Lacking PIK3CA Mutations (WT), Arm C - Patients Lacking PIK3CA Mutations (WT), Arm D - Patients with PIK3CA Mutation (MT), Arm E - Patients with PIK3CA Mutation (MT)
Breast Cancer Clinical Trial 2023: Fulvestrant Highlights & Side Effects. Trial Name: NCT05501886 — Phase 3
Fulvestrant (Estrogen Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05501886 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people can join this trial at most?

"In order to move forward with this clinical trial, 701 patients that meet the specified inclusion criteria must enroll. These potential participants can be based out of CARTI Cancer Center in Little Rock, Arkansas or Oncology, ArkansRTI Cancer Center in Little Rock, Arkansas or Oncology Consultants in Houston, Texas."

Answered by AI

What are the FDA regulations surrounding patients who lack PIK3CA mutations?

"Arm A - Patients Lacking PIK3CA Mutations (WT) is backed by prior clinical data and Phase 3 trials, making it a safe option with a score of 3."

Answered by AI

Can people sign up for this clinical trial at the moment?

"Yes, as per the information available on clinicaltrials.gov this trial is still ongoing and looking for participants. The listing was first created on September 30th, 2020 with the most recent update occurring on November 9th, 2020."

Answered by AI

In how many diverse places is this experiment being conducted?

"As of right now, the clinical trial is being conducted at 76 different sites. These locations include Little Rock, Houston and Jonesboro. To cut down on travel time and effort, patients are encouraged to enroll at the location nearest them."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
Michigan
Virginia
How old are they?
18 - 65
What site did they apply to?
University of Alabama at Birmingham
Virginia Cancer Institute
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
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)
2022. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05501886.
All > Breast Cancer Austin > Toronto
~263 spots leftby Sep 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top