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Monoclonal Antibodies
ARV-471 + Palbociclib for Advanced Breast Cancer (VERITAC-3 Trial)
Phase 3
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No prior systemic treatment for loco-regional recurrent or metastatic disease
Confirmed diagnosis of ER+/HER2- breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 12 weeks from randomization date, every 12 week, to the date of progression or death (up to approximately 4 years).
Awards & highlights
VERITAC-3 Trial Summary
This trial studies a new medication (ARV-471) with an existing one (palbociclib) to compare to standard of care therapy for advanced breast cancer.
Who is the study for?
This trial is for adults with advanced breast cancer that can't be cured by surgery or radiation, who haven't had systemic treatment for their recurrent or metastatic disease. They should have estrogen receptor positive and HER2 negative tumors, good performance status (ECOG 0-2), and be able to provide tissue samples.Check my eligibility
What is being tested?
The study tests ARV-471 combined with palbociclib against the standard letrozole plus palbociclib in treating advanced breast cancer. Initially, two doses of palbociclib are tested to find the best one for Phase 3, where participants will randomly receive either combination orally once daily until progression or unacceptable side effects.See study design
What are the potential side effects?
Potential side effects include reactions related to hormone therapy such as hot flashes and joint pain, along with those common to cancer treatments like nausea, fatigue, blood cell count changes which could increase infection risk, liver function alterations and possible heart issues.
VERITAC-3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't had systemic treatment for my cancer that has returned or spread.
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My breast cancer is ER positive and HER2 negative.
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My cancer can be measured by scans or is only in my bones.
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I am able to get out of my bed or chair and move around.
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My cancer has returned or spread and cannot be cured with surgery or radiation.
VERITAC-3 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 12 weeks from randomization date, every 12 week, to the date of progression or death (up to approximately 4 years).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 12 weeks from randomization date, every 12 week, to the date of progression or death (up to approximately 4 years).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 3: Progression-Free Survival
SLI: Incidence of dose reduction
SLI: Incidence of drug discontinuation.
+1 moreSecondary outcome measures
Phase 3: Changes from baseline in plasma ctDNA (Circulating Deoxyribonucleic Acid)
Phase 3: Disease- and treatment-related Quality of Life will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) breast cancer module (QLQ-BR23) questionnaire.
Phase 3: Disease-related Quality of Life will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30)
+9 moreVERITAC-3 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (Investigational Arm)Experimental Treatment2 Interventions
Participants will receive:
ARV-471, orally, once daily, continuously, in a 28-day cycle, plus
Palbociclib, orally, once daily for 21 consecutive days followed by 7 days off treatment in a 28 day cycle
Group II: Arm B (Comparator Arm):Active Control2 Interventions
Participants will receive:
Letrozole, orally, once daily, continuously, in a 28-day cycle, plus
Palbociclib, orally, once daily for 21 consecutive days followed by 7 days off treatment, in a 28-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palbociclib
2017
Completed Phase 3
~3760
Find a Location
Who is running the clinical trial?
Arvinas Estrogen Receptor, Inc.Industry Sponsor
17 Previous Clinical Trials
1,189 Total Patients Enrolled
7 Trials studying Breast Cancer
475 Patients Enrolled for Breast Cancer
PfizerLead Sponsor
4,570 Previous Clinical Trials
10,914,846 Total Patients Enrolled
111 Trials studying Breast Cancer
35,264 Patients Enrolled for Breast Cancer
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,476 Previous Clinical Trials
8,091,041 Total Patients Enrolled
42 Trials studying Breast Cancer
11,628 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver, kidneys, and bone marrow are not working well.I cannot take pills normally due to severe nausea, vomiting, or certain stomach/intestinal surgeries.I have heart problems or significant heart disease.I haven't had systemic treatment for my cancer that has returned or spread.My cancer came back while on hormone therapy or within a year after finishing it.My breast cancer is ER positive and HER2 negative.My cancer can be measured by scans or is only in my bones.I am able to get out of my bed or chair and move around.I have not been treated with specific breast cancer drugs like CDK4/6 inhibitors or SERDs.My cancer has returned or spread and cannot be cured with surgery or radiation.I am using or might need strong CYP3A4 inhibitors or inducers.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (Comparator Arm):
- Group 2: Arm A (Investigational Arm)
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.
What potential dangers should participants in Arm A (Investigational Arm) be aware of?
"Our analysts at Power rated Arm A (Investigational Arm) with a 3 on the safety scale, as this is an advanced stage trial and there are data points that suggest efficacy along with multiple rounds of evidence backing its security."
Answered by AI
How many participants are permitted to join this experiment?
"Affirmative. According to records available on clinicaltrials.gov, this medical investigation is actively seeking participants after its June 28th 2023 posting date and last update of 8th June 2023. The study specifically requires 1180 patients from a single location."
Answered by AI
Are researchers presently enlisting participants for this research project?
"According to the data available on clinicaltrials.gov, recruitment for this trial is in progress; it has been running since June 28th 2023 and was last updated less than two weeks ago."
Answered by AI
What aims is this research attempting to accomplish?
"The primary goal for this clinical trial, which will be analyzed over a 28 day cycle period, is to measure the incidence of dose reduction. Secondary objectives include measuring SLI and Phase 3's Duration of Response (defined as time from first documented evidence of CR or PR until progressive disease/death due to any cause), Clinical Benefit Rate (proportion who have confirmed CR/PR at any time/SD or non CR/non PD for 24 weeks) and Overall Survival (time interval from randomization to date of death)."
Answered by AI
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