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

NCT06206837 · tracked via the Priya Life Science China tracker

Sponsor

Pfizer

Phase

Phase 1/2

Started

2024-02-19

Last updated

2026-02-27

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

vepdegestrant →PF-07220060 →

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

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Phase 1b: Number of Participants With Dose Limiting Toxicities — 28 days
Dose Limiting Toxicities (DLTs) rate for Vepdegestrant in combination with PF-07220060, estimated based on data from DLT-evaluable participants during the DLT observation period (Cycle 1).
Phase 2: Percentage of Participants With Objective Response by investigator assessment — Up to approximately 1 year
Objective response (OR) refers to confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. as determined by investigator assessment.

Trial sites (58)

Facility	City	Region
Highlands Oncology	Fayetteville	Arkansas
Highlands Oncology	Rogers	Arkansas
Highlands Oncology Group	Springdale	Arkansas
Hoag Health Center Irvine	Irvine	California
Hoag Hospital Irvine	Irvine	California
Hoag Memorial Hospital Presbyterian	Newport Beach	California
Stanford Cancer Center	Palo Alto	California
Stanford Cancer Institute - Clinical Trials Office	Palo Alto	California
Stanford Women's Cancer Center	Palo Alto	California
UCSF Medical Center at Mission Bay	San Francisco	California
UCHealth Poudre Valley Hospital	Fort Collins	Colorado
UCHealth Harmony	Fort Collins	Colorado
UCHealth Greeley Hospital	Greeley	Colorado
UCHealth - Medical Center of the Rockies	Loveland	Colorado
Smilow Cancer Hospital - Yale New Haven Health	New Haven	Connecticut
Yale - New Haven Hospital - Yale Cancer Center	New Haven	Connecticut
Smilow Cancer Hospital Phase 1 Unit	New Haven	Connecticut
Smilow Cancer Hospital - Trumbull	Trumbull	Connecticut
START Midwest	Grand Rapids	Michigan
MSK Basking Ridge	Basking Ridge	New Jersey
MSK Monmouth	Middletown	New Jersey
MSK Bergen	Montvale	New Jersey
MSK Commack	Commack	New York
MSK Westchester	Harrison	New York
Rockefeller Outpatient Pavilion (53rd Street)	New York	New York
Evelyn H. Lauder Breast and Imaging Center (BAIC).	New York	New York
Memorial Sloan Kettering Cancer Center	New York	New York
MSK Nassau	Uniondale	New York
START San Antonio	San Antonio	Texas
University of Utah, Farmington Health Center	Farmington	Utah
University of Utah, Sugar House Health Center	Salt Lake City	Utah
Huntsman Cancer Institute	Salt Lake City	Utah
South Jordan Health Center - University of Utah	South Jordan	Utah
START Mountain Region	West Valley City	Utah
Antwerp University Hospital	Edegem	Antwerpen
Institut Jules Bordet	Anderlecht	Bruxelles-capitale, Région de
UZ Leuven	Leuven	Vlaams-brabant
AZ Groeninge Campus Kennedylaan	Kortrijk	West-vlaanderen
The Ottawa Hospital - General Campus	Ottawa	Ontario
Sunnybrook Research Institute	Toronto	Ontario

+ 18 more sites — see the full list on the official registry below.

More Pfizer trials in China

Vepdegestrant (ARV-471/PF-07850327) + Palbociclib vs Letrozole + Palbociclib in ER(+)/HER2(-) Advanced Breast Cancer Active, not recruiting

Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors Recruiting

MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide) Recruiting

A Long-Term Study to Learn About The Study Medicine Called Ritlecitinib in Children With Severe Alopecia Areata. Recruiting

A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC) Recruiting

Other trials for the same condition

A Study of BL-B01D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors Recruiting

ACHP-THP vs EC-THP as Neoadjuvant Therapy for HER2-positive EBC Active, not recruiting

A Clinical Study of TQB2102 Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of HER2 Positive Recurrent or Metastatic Breast Cancer Recruiting

A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+/HER2- Breast Cancer After Failure of Prior Endocrine Therapy(PANKU-Breast03) Recruiting

Myeloprotection With Trilaciclib in Pan-cancer Population Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06206837 on ClinicalTrials.gov ↗ ← All trials in China