A Study to Learn About Vepdegestrant When Given With PF-07220060 to People With Advanced or Metastatic Breast Cancer.

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Breast Cancer

In brief

The purpose of this study is to learn about the safety and effects of giving vepdegestrant along with PF-07220060. Vepdegestrant is studied to see if it can be a possible treatment for advanced metastatic breast cancer. This type of cancer would have spread from where it started (breast) to other parts of the body and would be tough to treat. The study is seeking for participants who have breast cancer that: * is hard to treat (advanced) and may have spread to other organs (metastatic). * is sensitive to hormonal therapy (it is called estrogen receptor positive). * is no longer responding to treatments taken before starting this study. All the participants will receive vepdegestrant and PF-07220060. Both medicines will be taken by mouth. The medicines will be taken at home. The experience of people receiving the study medicines will be studied. This will help see if the study medicines are safe and effective. Participants will continue to take vepdegestrant and PF-07220060 until: * their cancer is no longer responding, or * side effects become too severe. They will have visits at the study clinic about every 4 weeks.

Key facts

Study ID

NCT06206837

Run by

Pfizer

People needed

71

Starts

2024-02-19

Expected to finish

2026-09-07

Last updated by the study team

2026-02-27

Who can join

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

You may qualify if…

• Histological or cytological diagnosis of breast cancer. At time of enrollment this must not be amenable to surgical resection with curative intent (≥1% ER+ stained cells as per local practice on the most recent tumor biopsy HER2- tumor by IHC or in-situ hybridization per ASCO/CAP).
• prior anticancer therapies: Phase 1b: at least 1 line of SOC for A/MBC; Prior fulvestrant allowed; ≤1 prior chemotherapy line (no antibody-drug conjugates permitted) for A/MBC setting allowed. Phase 2: At least one and maximum 2 lines of ET in A/MBC setting and most recent ET-based regimen for >6 months.
• 1, and only 1, prior CDK4/6 inhibitor-based regimen required. Up to 1 prior regimen of cytotoxic chemotherapy (no antibody-drug conjugates permitted) in the A/MBC setting; Prior fulvestrant allowed.
• Participant with only non-measurable lesion (Phase1b) or at least 1 measurable lesion as defined by RECIST v1.1. (Phase2) are eligible.
• ECOG PS = 0 or 1 (Phase1b) ; ≤2 (Phase2)

You may not qualify if…

• visceral crisis at risk of life-threatening complications in the short term.
• Any condition precluding an adeguate absorption of study interventions.
• newly diagnosed brain metastases, or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease. Participants with a history of CNS metastases or cord compression are eligible if they have been definitively treated, clinically stable and discontinued anti-seizure medications and corticosteroids for at least 28 days prior to enrollment in the of study.
• history of any other tumor malignancies within the past 3 years, except for the following: (1) adequately treated basal or squamous cell carcinoma of the skin; (2) curatively treated in situ carcinoma of the cervix. Inflammatory breast cancer are excluded
• impaired cardiovascular function or clinically significant cardiovascular diseases.
• concurrent administration of medications, food, or herb supplements that are strong inhibitors/inducers of CYP3A or UGT2B7, moderate inducers of CYP34 (Phase1b only) and drugs known to predispose to Torsade de Pointes or QT interval prolongation.
• renal impairment, not adequate liver function and/or bone marrow function.
• known active infection

Where it is running

• Highlands Oncology — Rogers, Arkansas, United States
• Highlands Oncology Group — Springdale, Arkansas, United States
• Hoag Health Center Irvine — Irvine, California, United States
• Hoag Hospital Irvine — Irvine, California, United States
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
• Stanford Cancer Center — Palo Alto, California, United States
• Stanford Cancer Institute - Clinical Trials Office — Palo Alto, California, United States
• Stanford Women's Cancer Center — Palo Alto, California, United States
• UCSF Medical Center at Mission Bay — San Francisco, California, United States
• UCHealth Poudre Valley Hospital — Fort Collins, Colorado, United States
• UCHealth Harmony — Fort Collins, Colorado, United States
• UCHealth Greeley Hospital — Greeley, Colorado, United States
• UCHealth - Medical Center of the Rockies — Loveland, Colorado, United States
• Smilow Cancer Hospital - Yale New Haven Health — New Haven, Connecticut, United States
• Yale - New Haven Hospital - Yale Cancer Center — New Haven, Connecticut, United States
• Smilow Cancer Hospital Phase 1 Unit — New Haven, Connecticut, United States
• Smilow Cancer Hospital - Trumbull — Trumbull, Connecticut, United States
• START Midwest — Grand Rapids, Michigan, United States
• MSK Basking Ridge — Basking Ridge, New Jersey, United States
• MSK Monmouth — Middletown, New Jersey, United States
• MSK Bergen — Montvale, New Jersey, United States
• MSK Commack — Commack, New York, United States
• MSK Westchester — Harrison, New York, United States
• Rockefeller Outpatient Pavilion (53rd Street) — New York, New York, United States
• Highlands Oncology — Fayetteville, Arkansas, United States

Full record on ClinicalTrials.gov

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