A Study to Learn About a New Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People Who Have Advanced Metastatic Breast Cancer

Running, not enrolling · Phase 3

Conditions studied: Advanced Breast Cancer

In brief

A study to learn about a new medicine called ARV-471 (PF-07850327) in people who have advanced metastatic breast cancer.

Key facts

Study ID

NCT05654623

Run by

Pfizer

People needed

624

Starts

2023-03-03

Expected to finish

2028-05-15

Last updated by the study team

2026-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• California Cancer Associates for Research and Excellence, Inc. (cCARE) — Encinitas, California, United States
• Orange Coast Memorial Medical Center — Fountain Valley, California, United States
• California Cancer Associates for Research and Excellence — Fresno, California, United States
• Providence Queen of the Valley Medical Center — Napa, California, United States
• California Cancer Associates for Research and Excellence — San Marcos, California, United States
• Olive View-UCLA Medical Center — Sylmar, California, United States
• Smilow Cancer Hospital Care Center at Fairfield — Fairfield, Connecticut, United States
• Smilow Cancer Hospital at Yale-New Haven — New Haven, Connecticut, United States
• Yale-New Haven Hospital — New Haven, Connecticut, United States
• Smilow Cancer Hospital Care Center at North Haven — North Haven, Connecticut, United States
• Smilow Cancer Hospital Care Center at Trumbull — Trumbull, Connecticut, United States
• Florida Cancer Specialists — Altamonte Springs, Florida, United States
• Florida Cancer Specialists BON — Bonita Springs, Florida, United States
• Florida Cancer Specialists BCC — Bradenton, Florida, United States
• Florida Cancer Specialists LRS — Bradenton, Florida, United States
• Florida Cancer Specialists — Brandon, Florida, United States
• Florida Cancer Specialists NFM — Cape Coral, Florida, United States
• Morton Plant Hospital - BayCare Health System — Clearwater, Florida, United States
• Florida Cancer Specialists — Clearwater, Florida, United States
• Florida Cancer Specialists — Daytona Beach, Florida, United States
• Florida Cancer Specialists COL — Fort Myers, Florida, United States
• Florida Cancer Specialists GLO — Fort Myers, Florida, United States
• Florida Cancer Specialists — Gainesville, Florida, United States
• Lakeland Regional Cancer Center — Lakeland, Florida, United States
• Florida Cancer Specialists SAC — Sarasota, Florida, United States

Full record on ClinicalTrials.gov

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