Spots Global Cancer Trial Database for A Study of ARV-471 (PF-07850327) Plus Palbociclib Versus Letrozole Plus Palbociclib in Participants With Estrogen Receptor Positive, Human Epidermal Growth Factor Negative Advanced Breast Cancer
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Trial Identification
Brief Title: A Study of ARV-471 (PF-07850327) Plus Palbociclib Versus Letrozole Plus Palbociclib in Participants With Estrogen Receptor Positive, Human Epidermal Growth Factor Negative Advanced Breast Cancer
Official Title: A PHASE 3, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY OF ARV-471(PF-07850327) PLUS PALBOCICLIB VERSUS LETROZOLE PLUS PALBOCICLIB FOR THE TREATMENT OF PARTICIPANTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTI-CANCER TREATMENT FOR ADVANCED DISEASE (VERITAC-3)
Study ID: NCT05909397
Conditions
Study Description
Brief Summary: The purpose of this study is to understand the safety and effects of the study medicine ARV-471 (PF-07850327) given together with palbociclib in advanced breast cancer. In particular, the study will compare the combination of ARV-471 plus palbociclib to standard of care therapy (letrozole plus palbociclib). Both letrozole and palbociclib are medicines already used for treatment of breast cancer. ARV-471 is a new medicine under study. This study is seeking participants who have breast cancer that: * Have a locally advanced or metastatic disease and cannot be fully cured by surgery or radiation therapy. A metastatic disease is when disease has spread to other parts of the body. * Is sensitive to hormonal therapy such as tamoxifen. This is called estrogen receptor positive disease. * Have not received any prior medicine for advanced disease. Example medications include tamoxifen or letrozole or exemestane. The study will have an open-label SLI (study lead-in) before initiation of Phase 3 trial. During SLI, two dose levels of palbociclib in combination with ARV-471 will be explored in parallel. Assignment to the palbociclib dose is by chance. Half of the participant will receive one dose and the other half another palbociclib dose. The purpose of SLI is to determine the recommended Phase 3 dose of palbociclib to be administered in combination with ARV-471. In the Phase 3, half of the participants will take ARV-471 plus palbociclib while the other half will take letrozole plus palbociclib. In both SLI and Phase 3, participants will take the study medicines by mouth, with food, once a day. Participants will take the study medicines until breast cancer increase in size or side effects become too severe. Side effects refer to unwanted reactions to medications. Participants will visit the study clinic about once every 4 weeks.
Detailed Description: The purpose of this study is to demonstrate that ARV-471 in combination with palbociclib provides superior clinical benefit compared to letrozole in combination with palbociclib in participants with ER(+)/HER2(-) aBC who have not received any prior systemic anti-cancer therapies for their locoregionally advanced or metastatic disease. The study will have a Study Lead-in (SLI) and a Phase 3. In the SLI, 50 participants (approximately 25 each arm) will be randomly assigned on a 1:1 basis to one of the two dose levels (DLs). In the randomized Phase 3, approximately 1130 eligible participants (approximately 565 each arm) will be randomized in a 1:1 ratio to the Experimental Arm (ie, ARV-471 plus palbociclib at RP3D determined in the SLI) or Control Arm (ie, letrozole plus palbociclib at the registered doses). Randomization will be stratified by menopausal status at study entry, visceral disease and de novo metastatic disease.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Lakeland Regional Cancer Center, Lakeland, Florida, United States
Mid Florida Hematology and Oncology Center, Orange City, Florida, United States
University of Michigan, Ann Arbor, Michigan, United States
Mercy Clinic Oncology and Hematology, Ballwin, Missouri, United States
Mercy Research - David C. Pratt Cancer Center, Saint Louis, Missouri, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
SCRI Oncology Partners, Nashville, Tennessee, United States
Virginia Oncology Associates, Norfolk, Virginia, United States
Cancer Research SA, Adelaide, South Australia, Australia
Cabrini Hospital -Brighton, Brighton, Victoria, Australia
Barwon Health, Geelong, Victoria, Australia
Cabrini Hospital - Malvern, Malvern, Victoria, Australia
Hospital Santa Rita de Cassia, Vitoria, Espírito Santo, Brazil
Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa, Porto Alegre, RIO Grande DO SUL, Brazil
Centro de Pesquisa Clínica - Área Administrativa, Porto Alegre, RIO Grande DO SUL, Brazil
Hospital Mae de Deus, Porto Alegre, RIO Grande DO SUL, Brazil
A. C. Camargo Cancer Center, SP, SÃO Paulo, Brazil
Cancer Hospital Chinese Academy of Medical Science, Beijing, Beijing, China
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
Hubei Cancer Hospital, Wuhan, Hubei, China
The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Debreceni Egyetem Klinikai Kozpont, Debrecen, , Hungary
Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Campania, Italy
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Emilia-romagna, Italy
Fondazione IRCCS San Gerardo dei Tintori, Monza, Lombardia, Italy
Aichi Cancer Center Hospital, Nagoya, Aichi, Japan
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
Nemocnica na okraji mesta n o, Partizanske, , Slovakia
Fakultna nemocnica s poliklinikou J.A. Reimana Presov, Presov, , Slovakia
Institut Català d'Oncologia (ICO) - Badalona, Badalona, Barcelona [barcelona], Spain
Hospital Universitari Dexeus, Barcelona, Catalunya [cataluña], Spain
Complejo Hospitalario de Jaén, Jaen, Jaén, Spain
Hospital Universitario Virgen de la Victoria, Malaga, Málaga, Spain
Hospital Unviersitario Virgen Nieves, Granada, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Tumor Zentrum Aarau, Aarau, Aargau, Switzerland
CHUV (centre hospitalier universitaire vaudois), Lausanne, Vaud, Switzerland
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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