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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

No Placebo-Only Group

Pivotal 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.

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 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).

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

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.

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

~3790

0 / 9Eligibility criteria met