Status:
ACTIVE_NOT_RECRUITING
A Study to Learn About Vepdegestrant When Given With PF-07220060 to People With Advanced or Metastatic Breast Cancer.
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Arvinas Estrogen Receptor, Inc.
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 metast...
Detailed Description
C4891026 is a prospective, open-label, multicenter, Phase 1b/2 study to evaluate the safety, antitumor activity, and pharmacokinetic (PK) of vepdegestrant in combination with PF-07220060 in the treatm...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
February 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2026
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT06206837
Start Date
February 19 2024
End Date
March 6 2026
Last Update
September 23 2025
Active Locations (54)
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1
Highlands Oncology
Fayetteville, Arkansas, United States, 72703
2
Highlands Oncology
Rogers, Arkansas, United States, 72758
3
Highlands Oncology Group
Springdale, Arkansas, United States, 72762
4
Hoag Health Center Irvine
Irvine, California, United States, 92618