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Recruitment on holdLast updated: 17 June 2024

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

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 patients with ER+/HER2- breast cancer who have not had prior systemic treatment for their advanced disease

Cancer

Breast Cancers Breast

Age

People18+

Phase

III

Trial Acronym

VERITAC-3

More information

Trial Identifiers

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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

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.
  • Your cancer has spread to other parts of the body.
  • 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.

Ask your doctor if this trial could be right for you.

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