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Monoclonal Antibodies

ARV-471 + Palbociclib for Advanced Breast Cancer (VERITAC-3 Trial)

Phase 3
Waitlist Available
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
Must not have
Inadequate liver, kidney and bone marrow function
Refractory nausea and vomiting, inability to swallow capsules and tablets whole, chronic gastrointestinal diseases, significant gastric (total or partial) or bowel resection that would preclude adequate absorption of study interventions
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

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My liver, kidneys, and bone marrow are not working well.
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I cannot take pills normally due to severe nausea, vomiting, or certain stomach/intestinal surgeries.
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I have heart problems or significant heart disease.
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I am using or might need strong CYP3A4 inhibitors or inducers.

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).
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 12 weeks from randomization date, every 12 week, to the date of progression or death (up to approximately 4 years). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 3: Progression-Free Survival
SLI: Incidence of dose reduction
SLI: Incidence of drug discontinuation.
+1 more
Secondary study objectives
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 more

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
~3880

Find a Location

Who is running the clinical trial?

Arvinas Estrogen Receptor, Inc.Industry Sponsor
17 Previous Clinical Trials
1,194 Total Patients Enrolled
7 Trials studying Breast Cancer
477 Patients Enrolled for Breast Cancer
PfizerLead Sponsor
4,625 Previous Clinical Trials
14,283,014 Total Patients Enrolled
114 Trials studying Breast Cancer
40,291 Patients Enrolled for Breast Cancer
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,518 Previous Clinical Trials
11,457,590 Total Patients Enrolled
45 Trials studying Breast Cancer
16,622 Patients Enrolled for Breast Cancer

Media Library

ARV-471 (PF-07850327) (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05909397 — Phase 3
Breast Cancer Research Study Groups: Arm B (Comparator Arm):, Arm A (Investigational Arm)
Breast Cancer Clinical Trial 2023: ARV-471 (PF-07850327) Highlights & Side Effects. Trial Name: NCT05909397 — Phase 3
ARV-471 (PF-07850327) (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05909397 — Phase 3
~787 spots leftby Aug 2028
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