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A Study to Learn About Vepdegestrant When Given With PF-07220060 to People With Advanced or Metastatic Breast Cancer.
Sponsor: Pfizer
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.
Official title: AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF VEPDEGESTRANT (ARV-471/PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH PF-07220060 IN PARTICIPANTS AGED 18 YEARS AND OLDER WITH ER+/HER2- ADVANCED OR METASTATIC BREAST CANCER
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
71
Start Date
2024-02-19
Completion Date
2026-09-07
Last Updated
2026-02-27
Healthy Volunteers
No
Conditions
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
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
Locations (58)
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
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
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
University of Utah, Farmington Health Center
Farmington, Utah, United States
University of Utah, Sugar House Health Center
Salt Lake City, Utah, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
South Jordan Health Center - University of Utah
South Jordan, 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