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No longer recruiting (closed or complete)Last updated: 28 May 2025

VERITAC-3: This study will compare the safety and effectiveness of a new medicine (called ARV-471) when given with targeted therapy compared to standard of care treatment in people with advanced ER+/HER2- breast cancerA PHASE 3, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY OF ARV-471(PF-07850327) PLUS PALBOCICLIB VERSUS LETROZOLE PLUS PALBOCICLIB FOR THE TREATMENT OF PARTICIPANTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTI-CANCER TREATMENT FOR ADVANCED DISEASE

Trial purpose

Medical clipboardCancer treatment

Tumor type

Breast Cancers Breast

Age

People18+

Trial acronym

VERITAC-3

Clinical summary

Summary

This study will have an open-label study lead-in prior to the Phase 3 part of the trial.

During the study lead-in, two dose levels of targeted therapy (called palbociclib) in combination with the study drug (called ARV-471) will be explored in parallel. Eligible participants will be randomly allocated to either receive one of the two dose levels of palbociclib plus ARV-471. The purpose of the study lead-in is to determine the recommended Phase 3 dose of palbociclib to be administered in combination with ARV-471.

In the Phase 3 part of the trial, eligible participants will be randomly allocated to one of two treatment arms. 

In Arm A (Experimental), participants will receive ARV-471 (orally, once daily) plus palbociclib (orally, once daily).

In Arm B (Active Comparator), participants will receive standard of care therapy consisting of letrozole (orally, once daily) plus palbociclib (orally, once daily).

 

Conditions

This trial is treating people with ER+/HER2- breast cancer who have not had prior systemic treatment for their advanced disease

Eligibility

Inclusion

  • Adult participants with loco-regional recurrent or metastatic disease not amenable to curative treatment
  • Confirmed diagnosis of ER+/HER2- breast cancer
  • No prior systemic treatment for loco-regional recurrent or metastatic disease
  • Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Phase 3 only: Participants should be willing to provide blood and tumor tissue

Exclusion

  • Disease recurrence while on, or within 12 months of completion of adjuvant endocrine therapy
  • Prior treatment with cyclin dependent kinase 4/6 inhibitors (CDK4/6i), fulvestrant, elacestrant and other investigational drugs including novel endocrine therapies, any selective estrogen receptor degraders (SERDs), covalent antagonists (SERCAs) and complete ER antagonists (CERANs).
  • Inadequate liver, kidney and bone marrow function
  • Impaired cardiovascular function or clinically significant cardiovascular diseases
  • 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.
  • Current use or anticipated need for food, herbal supplements or drugs that are known strong CYP3A4 inhibitors or inducers.

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You are able to swallow medication by mouth.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

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Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Pfizer

Scientific Title

A PHASE 3, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY OF ARV-471(PF-07850327) PLUS PALBOCICLIB VERSUS LETROZOLE PLUS PALBOCICLIB FOR THE TREATMENT OF PARTICIPANTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTI-CANCER TREATMENT FOR ADVANCED DISEASE

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