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

NCT ID: NCT06206837

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-19
• Study Completion Date: 2026-03-06

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 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.

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 treatment of participants with Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Advanced or Metastatic Breast Cancer.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

vepdegestrant in combination with PF-07220060

vepdegestrant administered orally once daily (QD) continuously and PF-07220060 administered orally twice daily (BID) continuously on 28-day cycles

Group Type: EXPERIMENTAL

vepdegestrant

Intervention Type: DRUG

Daily oral dosages of vepdegestrant continuously, dose escalation/de-escalation in Phase 1b until recommended phase 2 dose (RP2D) determined, cycles lasting 28 days

PF-07220060

Intervention Type: DRUG

Daily oral dosages of PF-07220060 continuously, dose escalation/de-escalation in Phase 1b until recommended phase 2 dose (RP2D) determined, cycles lasting 28 days

Interventions

vepdegestrant

Daily oral dosages of vepdegestrant continuously, dose escalation/de-escalation in Phase 1b until recommended phase 2 dose (RP2D) determined, cycles lasting 28 days

Intervention Type: DRUG

PF-07220060

Daily oral dosages of PF-07220060 continuously, dose escalation/de-escalation in Phase 1b until recommended phase 2 dose (RP2D) determined, cycles lasting 28 days

Intervention Type: DRUG

Other Intervention Names

ARV-471 / PF07850327

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arvinas Estrogen Receptor, Inc.

INDUSTRY

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Highlands Oncology

Fayetteville, Arkansas, United States

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

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

Evelyn H. Lauder Breast and Imaging Center (BAIC).

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

MSK Nassau

Uniondale, New York, United States

START San Antonio

San Antonio, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

START Mountain Region

West Valley City, Utah, United States

Antwerp University Hospital

Edegem, Antwerpen, Belgium

Institut Jules Bordet

Anderlecht, Bruxelles-capitale, Région de, Belgium

UZ Leuven

Leuven, Vlaams-brabant, Belgium

AZ Groeninge Campus Kennedylaan

Kortrijk, West-vlaanderen, Belgium

The Ottawa Hospital - General Campus

Ottawa, Ontario, Canada

Sunnybrook Research Institute

Toronto, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Wuhan Union Hospital Cancer Center

Wuhan, Hubei, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Institut Régional du Cancer Montpellier

Montpellier, Hérault, France

Institut de Cancérologie de l'Ouest

Saint-Herblain, Loire-atlantique, France

Institut Paoli-Calmettes

Marseille, Provence-Alpes-Côte d'Azur Region, France

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Kanagawa cancer center

Yokohama, Kanagawa, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Showa Medical University Hospital

Tokyo, , Japan

BRCR Global - Mayaguez Administrative Office

Mayagüez, , Puerto Rico

BRCR Global - Mayagüez

Mayagüez, , Puerto Rico

Pan American Center for Oncology Trials, LLC

Rio Piedras, , Puerto Rico

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [barcelona], Spain

Hospital Universitario Arnau de Vilanova de Lleida

Lleida, Lleida [lérida], Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad de, Spain

Hospital Universitario Virgen Del Rocio

Seville, , Spain

Countries

United States; Belgium; Canada; China; France; Japan; Puerto Rico; Spain

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=C4891026

To obtain contact information for a study center near you, click here.

Other Identifiers

TACTIVE-K

Identifier Type: OTHER

Identifier Source: secondary_id

2023-508130-33-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

C4891026

Identifier Type: -

Identifier Source: org_study_id