Spots Global Cancer Trial Database for TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study A)
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Trial Identification
Brief Title: TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study A)
Official Title: TACTIVE-U: An Interventional Safety and Efficacy Phase 1b/2, Open-label Umbrella Study to Investigate Tolerability, pk, and Antitumor Activity of Vepdegestrant (ARV-471/PF-07850327), an Oral Proteolysis Targeting Chimera, in Combination With Other Anticancer Treatments in Participants Aged 18 Years and Over With ER+ Advanced or Metastatic Breast Cancer, Sub-study A (ARV-471 in Combination With Abemaciclib)
Study ID: NCT05548127
Conditions
Study Description
Brief Summary: The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called ARV-471) when given together with other medicines for the potential treatment of advanced or metastatic breast cancer. This study is seeking participants who have breast cancer that: * is advanced, may have spread to other organs (metastatic) and cannot be fully treated by surgery or radiation therapy * is sensitive to hormonal therapy (it is called estrogen receptor positive); and * is no longer responding to previous treatments This study is divided into separate sub-studies. For Sub-Study A: All participants will receive ARV-471 and a medicine called abemaciclib. ARV-471 will be given by mouth, at home, 1 time a day. Abemaciclib will be given by mouth, at home, 2 times a day. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective. Participants will continue to take ARV-471 and abemaciclib 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: C4891006 is a sub-study from the Umbrella platform, TACTIVE-U, comprising multiple sub-studies that independently evaluate ARV-471 in participants with Estrogen Receptor Positive (ER+) Advanced or Metastatic Breast Cancer (A/MBC). ARV-471 will act as the backbone therapy given in combination with other anticancer agents thought to have clinical relevance in ER+ breast cancer.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Stanford Women's Cancer Center, 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
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center, Tampa, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Siteman Cancer Center - WUPI, Shiloh, Illinois, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Dana-Farber Cancer Institute - Chestnut Hill, Newton, Massachusetts, United States
Siteman Cancer Center - West County, Creve Coeur, Missouri, United States
Siteman Cancer Center - North County, Florissant, Missouri, United States
Barnes-Jewish Hospital, Saint Louis, Missouri, United States
Washington University School of Medicine - Siteman Cancer Center, Saint Louis, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Washington University, Saint Louis, Missouri, United States
Siteman Cancer Center - South County, Saint Louis, Missouri, United States
Siteman Cancer Center - St Peters, Saint Peters, Missouri, United States
U.T. MD Anderson Cancer Center, Investigational Pharmacy Services - Unit 376, Houston, Texas, United States
U.T. MD Anderson Cancer Center, Houston, Texas, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
BC Cancer Vancouver, Vancouver, British Columbia, Canada
BC Cancer Vancouver, Vancouver, British Columbia, Canada
The Ottawa Hospital - General Campus, Ottawa, Ontario, Canada
Sunnybrook Research Institute, Toronto, Ontario, Canada
CIUSSS- saguenay-Lac-Saint-Jean, Chicoutimi, Quebec, Canada
Jewish General Hospital, Montreal, Quebec, Canada
Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Campania, Italy
Humanitas Istituto Clinico Catanese, Misterbianco, Catania, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore, Roma, Lazio, Italy
Fondazione IRCCS San Gerardo dei Tintori, Monza, Lombardia, Italy
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia, Candiolo, Torino, Italy
Azienda Ospedaliero Universitaria delle Marche, Ancona, , Italy
Istituto Oncologico Veneto IRCCS, Padova, , Italy
Hospital Universitari Vall d'Hebron, Barcelona, Barcelona [barcelona], Spain
Hospital Universitari Dexeus, Barcelona, Catalunya [cataluña], Spain
Clinica Universidad de Navarra, Madrid, Madrid, Comunidad DE, Spain
Clínica Universidad de Navarra, Madrid, Madrid, Comunidad DE, Spain
Hospital Universitario 12 de Octubre, Madrid, Madrid, Comunidad DE, Spain
Clinica Universidad de Navarra, Pamplona, Navarra, Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
Hospital Universitario Virgen Del Rocio, Sevilla, , Spain
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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