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Estrogen Receptor Antagonist
Gedatolisib + Fulvestrant +/- Palbociclib for Advanced Breast Cancer (VIKTORIA-1 Trial)
Phase 3
Recruiting
Research Sponsored by Celcuity Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate archival or fresh tumor tissue for the analysis of PIK3CA mutational status
Documented HER2 immunohistochemistry (IHC) negative as per ASCO-CAP 2018 guidance
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 48 months
Awards & highlights
VIKTORIA-1 Trial Summary
This trial tests a combination of drugs to treat advanced breast cancer after other treatments have stopped working.
Who is the study for?
This trial is for adults with advanced or metastatic HR+/HER2- breast cancer who've progressed after CDK4/6 and aromatase inhibitor therapy. They must have a life expectancy of at least 3 months, ECOG status of 0-1, adequate organ function, and no pregnancy. Pre-menopausal women must agree to LHRH agonist treatment.Check my eligibility
What is being tested?
The study tests gedatolisib plus fulvestrant with or without palbociclib against standard care in patients whose breast cancer has worsened despite previous treatments. It's an open-label Phase 3 trial where participants are randomly assigned to different drug combinations.See study design
What are the potential side effects?
Potential side effects may include digestive issues, blood sugar changes (especially important for diabetics), hormonal imbalances due to LHRH agonists in pre-menopausal women, and possible reactions related to the immune system or liver functions.
VIKTORIA-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can provide a recent or past sample of my tumor for PIK3CA mutation testing.
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My cancer is HER2 negative according to the latest guidelines.
Select...
My cancer has grown or spread after my last treatment, confirmed by scans.
Select...
I am not pregnant and will use birth control during and for 1 year after the study.
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I am fully active or can carry out light work.
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I have been diagnosed with advanced breast cancer.
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My cancer is positive for estrogen or progesterone receptors.
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My cancer progressed after treatment with CDK4/6 inhibitors and AI.
VIKTORIA-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 48 months
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 moreVIKTORIA-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 E - Patients with PIK3CA Mutation (MT)Active Control2 Interventions
Alpelisib + Fulvestrant
Group VI: Arm C - Patients Lacking PIK3CA Mutations (WT)Active Control1 Intervention
Fulvestrant
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
2011
Completed Phase 3
~3690
Gedatolisib
2018
Completed Phase 1
~160
Palbociclib
2017
Completed Phase 3
~3760
Find a Location
Who is running the clinical trial?
Celcuity IncLead Sponsor
7 Previous Clinical Trials
315 Total Patients Enrolled
2 Trials studying Breast Cancer
197 Patients Enrolled for Breast Cancer
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a pre/peri-menopausal woman willing to start LHRH agonist treatment.I can provide a recent or past sample of my tumor for PIK3CA mutation testing.My cancer is only in the bones and does not affect soft tissues.My cancer has spread to my organs and is causing symptoms that could quickly become life-threatening.My blood, liver, kidneys, and clotting functions are all working well.I have advanced breast cancer and am willing to start hormone therapy if pre-menopausal.My cancer is HER2 negative according to the latest guidelines.I have untreated brain or spinal cord cancer spread.I have a history of serious heart problems.My cancer has grown or spread after my last treatment, confirmed by scans.I am not pregnant and will use birth control during and for 1 year after the study.I have received chemotherapy and antibody drug treatments for my advanced disease.I am fully active or can carry out light work.My blood pressure is not controlled, even with medication.I do not have Long QT syndrome or a family history of sudden death.I have been treated with a PI3K, Akt, or mTOR inhibitor before.I have type 1 diabetes or my type 2 diabetes is not under control.I have had more than two hormone therapy treatments.Women who could become pregnant must have a negative pregnancy test.I have no cancer history except for certain treated skin cancers, cervical in situ cancer, or solid tumors with no signs for 3+ years.I have been diagnosed with advanced breast cancer.You are expected to live for at least 3 more months.My cancer is positive for estrogen or progesterone receptors.My cancer progressed after treatment with CDK4/6 inhibitors and AI.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B - Patients Lacking PIK3CA Mutations (WT)
- Group 2: Arm D - Patients with PIK3CA Mutation (MT)
- Group 3: Arm A - Patients Lacking PIK3CA Mutations (WT)
- Group 4: Arm E - Patients with PIK3CA Mutation (MT)
- Group 5: Arm F - Patients with PIK3CA Mutation (MT)
- Group 6: Arm C - Patients Lacking PIK3CA Mutations (WT)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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 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
Fred Hutchinson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
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