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RecruitingLast updated: 30 November 2023

VERITAC-2: The purpose of this study is to learn about the safety and effects of a type of hormone treatment (called vepdegestrant) compared to existing hormone treatment (called fulvestrant) in people with advanced ER+, HER2- advanced breast cancer whose cancer has progressed after previous endocrine based treatmentA Phase 3, Randomized, Open-Labe, Multicenter Trial of ARV-471 (PF-07850327) vs Fulvestrant in Participants with Estrogen Reeptor-Positive, HER2-Negative Advanced Breast Cancer Whose Disease Progressed After Prior Endocrine Based Treatment for Advanced Disease

Clinical summary

Summary

This study is recruiting people with advanced (recurrent or metastatic) ER+/HER2- breast cancer who have had prior treatment with endocrine therapy. Eligible participants will be ranomly allocated to either the Experimental Arm or Active Comparator Arm.

In the Experimental Arm, participants will receive the new hormone treatment (called vepdegestrant or ARV-471) which will be administered orally once daily on a 28-day continuous dosing schedule.

In the Active Comparator Arm, participants will receive the hormone treatment called fulvestrant, which will be administered via intramuscular injection on Days 1 and 15 of Cycle 1, and then on Day 1 of each cycle startted from CD21. Each cycle will be 28-days. 

Conditions

This trial is treating patients with ER+, HER2- advanced breast cancer

Cancer

Breast Cancers Breast

Age

People18+

Phase

III

Trial Acronym

VERITAC-2

More information

Trial Identifiers

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Trial sponsor

Pfizer

Scientific Title

A Phase 3, Randomized, Open-Labe, Multicenter Trial of ARV-471 (PF-07850327) vs Fulvestrant in Participants with Estrogen Reeptor-Positive, HER2-Negative Advanced Breast Cancer Whose Disease Progressed After Prior Endocrine Based Treatment for Advanced Disease

Eligibility

Inclusion

  • Adult participants with loco-regional recurrent or metastatic breast disease not amenable to surgical resection or radiation therapy
  • Confirmed diagnosis of ER+/HER2- breast cancer
  • Prior therapies for locoregional recurrent or metastatic disease must fulfill all the following criteria:
  • One line of CDK4/6 inhibitor therapy in combination with endocrine therapy. Only one line of CDK4/6 inhibitor is allowed in any setting.
  • ≤ 1 endocrine therapy in addition to CDK4/6 inhibitor with ET
  • Most recent endocrine treatment duration must have been given for ≥6 months prior to disease progression. This may be the endocrine treatment component of the CDK4/6 inhibitor line of therapy.
  • Radiological progression during or after the last line of therapy.
  • 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 0-1
  • Participants should be willing to provide blood and tumor tissue

Exclusion

  • Participants with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term
  • Prior treatment with:
  • ARV-471, fulvestrant, elacestrant, mTOR, PI3K, AKT pathway inhibitors, PARP inhibitor for any setting
  • other investigational agents (including novel endocrine therapy any SERDs, SERCAs, CERANs) for any setting
  • prior chemotherapy for advanced/metastatic disease
  • Inadequate liver, kidney and bone marrow function
  • Active brain metastases
  • Participants with significant concomitant illness

Inclusion

  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.
  • You have had treatment, but your cancer has come back.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

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

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