Breast Cancer Clinical Trial

A Study to Learn About a New Medicine Called ARV-471 (PF-07850327) in People Who Have Advanced Metastatic Breast Cancer.

Summary

A study to learn about a new medicine called ARV-471 (PF-07850327) in people who have advanced metastatic breast cancer.

View Full Description

Full Description

The purpose of this study is to learn about the safety and effects of the study medicine ARV-471 (PF-07850327) compared to fulvestrant (FUL) in participants with advanced breast cancer. FUL is a medicine already used for treatment of breast cancer while ARV-471 is a new medicine.

This study is seeking participants with breast cancer who:

Have a disease that comes back in the place where it started or in the nearby region (locoregional recurrent disease) or have a disease that has spread to other parts of the body (metastatic) and cannot be fully cured by surgery or radiation therapy
Are responsive to hormonal therapy such as tamoxifen (it is called estrogen receptor positive disease)
Have received one line of CDK4/6 inhibitor therapy (for example palbociclib) in combination with endocrine therapy (for example letrozole) for advanced disease.
Allowed up to one additional endocrine therapy (for example exemestane) for advanced disease.

Half of the participants will be given ARV-471 while half of the participants will be given FUL.

Participants will take ARV-471 by mouth with food, one time a day. During the first treatment cycle participants will be given FUL by shots into the muscles on Day 1 and again 2 weeks later. Afterwards, FUL shots will be given on the first day of each new treatment cycle. One treatment cycle is 28 days

Participants will receive the study medicine until their breast cancer worsens or side effects become too severe. Participants will have visits at the study clinic about every 4 weeks.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Adult participants with loco-regional recurrent or metastatic breast disease not amenable to surgical resection or radiation therapy
Confirmed diagnosis of ER+/HER2- breast cancer
Prior therapies for locoregional recurrent or metastatic disease must fulfill all the following criteria:
One line of CDK4/6 inhibitor therapy in combination with endocrine therapy
≤ 1 endocrine therapy in addition to CDK4/6 inhibitor with ET
Most recent endocrine treatment duration must have been given for ≥6 months prior to disease progression
Radiological progression during or after the last line of therapy
Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Participants should be willing to provide blood and tumor tissue

Exclusion Criteria:

Participants with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term
Prior treatment with:
ARV-471, fulvestrant, mTOR, PI3K, AKT pathway inhibitors, PARP inhibitor for any setting
other investigational novel endocrine therapy (ie, SERD, SERCA, CERAN) for any setting
prior CDK4/6 inhibitor treatment in the neoadjuvant/ adjuvant setting
prior chemotherapy for advanced/metastatic disease
Inadequate liver, kidney and bone marrow function
Active brain metastases
Participants with significant concomitant illness

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

560

Study ID:

NCT05654623

Recruitment Status:

Recruiting

Sponsor:

Pfizer

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There are 160 Locations for this study

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California Cancer Associates for Research and Excellence, Inc. (cCARE)
Encinitas California, 92024, United States
California Cancer Associates for Research and Excellence
Fresno California, 93720, United States
Providence Queen of the Valley Medical Center
Napa California, 94558, United States
California Cancer Associates for Research and Excellence
San Marcos California, 92069, United States
Providence Medical Foundation
Santa Rosa California, 95403, United States
Florida cancer specialists
Altamonte Springs Florida, 32701, United States
Florida Cancer Specialists BON
Bonita Springs Florida, 34135, United States
Florida Cancer Specialists BCC
Bradenton Florida, 34205, United States
Florida Cancer Specialists LRS
Bradenton Florida, 34211, United States
Florida Cancer Specialists
Brandon Florida, 33511, United States
Morton Plant Hospital - BayCare Health System
Clearwater Florida, 33756, United States
Florida Cancer Specialists
Clearwater Florida, 33761, United States
3T Radiology LLC
Coconut Creek Florida, 33073, United States
Florida Cancer Specialists
Daytona Beach Florida, 32117, United States
Florida Cancer Specialists
Fleming Island Florida, 32003, United States
Florida Cancer Specialists - South
Fort Myers Florida, 33901, United States
Florida Cancer Specialists COL
Fort Myers Florida, 33905, United States
Florida Cancer Specialists GLO
Fort Myers Florida, 33908, United States
Florida Cancer Specialists
Gainesville Florida, 32605, United States
Lakeland Regional Cancer Center
Lakeland Florida, 33805, United States
Florida Cancer Specialists
Largo Florida, 33770, United States
Broward P.E.T. Imaging Center
Lauderdale Lakes Florida, 33313, United States
Florida Cancer Specialists
Lecanto Florida, 34461, United States
Florida Cancer Specialists NGD
Naples Florida, 34102, United States
Florida Cancer Specialists NPW
Naples Florida, 34102, United States
Florida Cancer Specialists
Ocala Florida, 34474, United States
Florida Cancer specialists
Orange City Florida, 32763, United States
Mid Florida Hematology and Oncology Center
Orange City Florida, 32763, United States
Florida Cancer Specialists
Orlando Florida, 32806, United States
POM MRI & Radiology Centers
Plantation Florida, 33313, United States
BRCR Global
Plantation Florida, 33322, United States
Florida Cancer Specialists
Saint Petersburg Florida, 33705, United States
Florida Cancer Specialists SAC
Sarasota Florida, 34232, United States
Florida Cancer Specialists SAD
Sarasota Florida, 34236, United States
Florida Cancer Specialists
Stuart Florida, 34994, United States
Florida Cancer Specialists
Tallahassee Florida, 32308, United States
Impression Imaging
Tamarac Florida, 33321, United States
Florida Cancer Specialists
Tampa Florida, 33607, United States
Florida Cancer Specialists
The Villages Florida, 32159, United States
Florida Cancer Specialist
Trinity Florida, 34655, United States
Florida Cancer Specialists VIS
Venice Florida, 34285, United States
Florida Cancer Specialists VHP
Venice Florida, 34292, United States
Florida Cancer Specialists
Vero Beach Florida, 32960, United States
Florida Cancer Specialists
Wellington Florida, 33414, United States
Florida Cancer Specialists
West Palm Beach Florida, 33401, United States
Florida Cancer Specialists
Winter Park Florida, 32789, United States
Louisiana State University Health Sciences Shreveport
Shreveport Louisiana, 71103, United States
Comprehensive Cancer Centers of Nevada
Henderson Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada
Henderson Nevada, 89074, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89128, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89144, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89148, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89169, United States
Hematology-Oncology Associates of Central New York, PC
East Syracuse New York, 13057, United States
Hematology Oncology Associates of Rockland
Nyack New York, 10960, United States
Cancer Centers of Southwest Oklahoma
Lawton Oklahoma, 73505, United States
Cancer Centers of Southwest Oklahoma
Lawton Oklahoma, 73506, United States
Frank C Love Cancer Institute
Oklahoma City Oklahoma, 73102, United States
Hightower Clinical Trial Services
Oklahoma City Oklahoma, 73102, United States
SSM Health Medical Group - St Anthony
Oklahoma City Oklahoma, 73102, United States
Tennessee Oncology, PLLC
Dickson Tennessee, 37055, United States
Tennessee Oncology PLLC
Franklin Tennessee, 37067, United States
Tennessee Oncology PLLC
Gallatin Tennessee, 37066, United States
Tennessee Oncology PLLC
Hendersonville Tennessee, 37075, United States
Tennessee Oncology PLLC
Hermitage Tennessee, 37076, United States
Tennessee Oncology PLLC
Lebanon Tennessee, 37090, United States
Tennessee Oncology PLLC
Murfreesboro Tennessee, 37129, United States
Tennessee Oncology PLLC
Nashville Tennessee, 37203, United States
Tennessee Oncology, PLLC
Nashville Tennessee, 37203, United States
Tennessee Oncology PLLC
Nashville Tennessee, 37205, United States
Tennessee Oncology PLLC
Nashville Tennessee, 37207, United States
Tennessee Oncology PLLC
Nashville Tennessee, 37211, United States
Tennessee Oncology, PLLC
Shelbyville Tennessee, 37160, United States
Tennessee Oncology PLLC
Smyrna Tennessee, 37167, United States
Valley Cancer Associates
Harlingen Texas, 78550, United States
The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center
Tyler Texas, 75701, United States
Hematology Oncology Associates of Fredericksburg
Fredericksburg Virginia, 22408, United States
Sunshine Coast University Private Hospital
Birtinya Queensland, 4575, Australia
Sunshine Coast University Private Hospital
Birtinya Queensland, 4575, Australia
Icon Cancer Centre Hobart
Hobart Tasmania, 7000, Australia
Cabrini Hospital -Brighton
Brighton Victoria, 3186, Australia
Cabrini Hospital - Malvern
Malvern Victoria, 3144, Australia
Cliniques universitaires Saint-Luc
Woluwe-Saint-Lambert Bruxelles-capitale, Région DE, 1200, Belgium
Grand Hôpital de Charleroi
Charleroi Hainaut, 6000, Belgium
Faculdade de Medicina do ABC
Santo André SÃO Paulo, 09060, Brazil
Complex Oncology Center - Burgas
Burgas , 8000, Bulgaria
Specialized Hospital for Active Treatment of Oncology - Haskovo
Haskovo , 6300, Bulgaria
Complex Oncology Center - Ruse EOOD
Ruse , 7002, Bulgaria
Complex Oncology Center - Vratsa
Vratsa , 3000, Bulgaria
The Moncton Hospital
Moncton New Brunswick, E1C 6, Canada
Grand River Hospital
Kitchener Ontario, N2G 1, Canada
Anhui Provincial Cancer Hospital
Hefei Anhui, 23003, China
Sun Yat-sen University Cancer Center
Guangzhou Guangdong, 51006, China
Wuhan Union Hospital Cancer Center
Wuhan Hubei, 43002, China
Hubei Cancer Hospital
Wuhan Hubei, 43007, China
Fudan University Shanghai Cancer Center
Shanghai Shanghai, 20003, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou Zhejiang, 31001, China
Fakultni Thomayerova nemocnice
Prague Praha 4, 14059, Czechia
Tampereen yliopistollinen sairaala
Tampere Pirkanmaa, 33520, Finland
Satakunnan Keskussairaala
Pori , 28500, Finland
Centre Georges François Leclerc
Dijon Côte-d'or, 21079, France
Institut de Cancérologie de l'Ouest
ANGERS cedex 02 Maine-et-loire, 49055, France
Onkologische Schwerpunktpraxis Kurfuerstendamm
Berlin , 10707, Germany
University Hospital of Patras
Patras Achaḯa, 26504, Greece
City Cancer Centre - Vijayawada
Vijayawada Andhra Pradesh, 52000, India
Hcg Pet Imaging Centre
Vijayawada Andhra Pradesh, 52000, India
Rajiv Gandhi Cancer Institute And Research Centre
New Delhi Delhi, 11008, India
Artemis hospital
Gurgaon Haryana, 12200, India
HCG Manavata Cancer Centre
Nashik Maharashtra, 42200, India
Bhakti Vedanta Hospital and Research Institute
Thane Maharashtra, 40110, India
Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
Kolkata WEST Bengal, 70002, India
Yitzhak Shamir Medical Center
Zerifin Hamerkaz, 70300, Israel
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Napoli Campania, 80131, Italy
Humanitas Istituto Clinico Catanese
Misterbianco Catania, 95045, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna Emilia-romagna, 40138, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuor
Roma Lazio, 00168, Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza Lombardia, 20900, Italy
Azienda Ospedaliero Universitaria delle Marche
Ancona Marche, 60126, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa Toscana, 56126, Italy
Aichi Cancer Center Hospital
Nagoya Aichi, 464-8, Japan
Nagoya University Hospital
Nagoya Aichi, 466-8, Japan
Nagoya City University Hospital
Nagoya Aichi, 467-8, Japan
Chiba cancer center
Chiba-shi Chiba, 260-8, Japan
National Cancer Center Hospital East
Kashiwa Chiba, 277-8, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo Hokkaido, 003-0, Japan
Kanagawa cancer center
Yokohama Kanagawa, 24185, Japan
Osaka University Hospital
Suita Osaka, 565-0, Japan
Tokyo Metropolitan Komagome Hospital, Department of Breast Surgery
Bunkyo-ku Tokyo, 113-8, Japan
Japanese Foundation for Cancer Research
Koto Tokyo, 135-8, Japan
National Center for Global Health and Medicine
Shinjuku City Tokyo, 162-8, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka , 811-1, Japan
Sagara Hospital
Kagoshima , 892-0, Japan
Okayama University Hospital
Okayama , 700-8, Japan
Gachon University Gil Medical Center
Namdong-gu Incheon-gwangyeoksi [incheon], 21565, Korea, Republic of
National Cancer Center
Goyang-si KyÇ’nggi-do, 10408, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam KyÇ’nggi-do, 13620, Korea, Republic of
Ajou University Hospital
Suwon KyÇ’nggi-do, 16499, Korea, Republic of
Korea University Anam Hospital
Seoul Seoul-teukbyeolsi [seoul], 02841, Korea, Republic of
Seoul National University Hospital
Seoul Seoul-teukbyeolsi [seoul], 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul Seoul-teukbyeolsi [seoul], 03722, Korea, Republic of
Asan Medical Center
Seoul Seoul-teukbyeolsi [seoul], 05505, Korea, Republic of
Gangnam Severance Hospital
Seoul Seoul-teukbyeolsi [seoul], 06273, Korea, Republic of
Samsung Medical Center
Seoul Seoul-teukbyeolsi [seoul], 06351, Korea, Republic of
Ewha Womans University Mokdong Hospital
Seoul Seoul-teukbyeolsi [seoul], , Korea, Republic of
Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.
Kraków Małopolskie, 30-34, Poland
COPERNICUS PL, Wojewodzkie Centrum Onkologii
Gdansk Pomorskie, 80-21, Poland
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
Lodz Łódzkie, 90-33, Poland
Puerto Rico Medical Research Center
Hato Rey , 00917, Puerto Rico
Pan American Center for Oncology Trials
Rio Piedras , 00935, Puerto Rico
FDI Clinical Research
San Juan , 00927, Puerto Rico
Onkologicky ustav sv. Alzbety, s.r.o.
Bratislava , 812 5, Slovakia
Vychodoslovensky onkologicky ustav, a.s.
Kosice , 04191, Slovakia
Nemocnica s poliklinikou Stefana Kukuru Michalovce, a.s.
Michalovce , 07101, Slovakia
Nemocnica na okraji mesta n o
Partizanske , 95801, Slovakia
Iatros International
Bloemfontein FREE State, 9301, South Africa
Medical Oncology Centre of Rosebank
Johannesburg Gauteng, 2196, South Africa
Parc de Salut Mar - Hospital del Mar
Barcelona Barcelona [barcelona], 08003, Spain
Hospital Universitario Arnau de Vilanova de Lleida
Lleida Lleida [lérida], 25198, Spain
Hospital Universitario Virgen Nieves
Granada , 18012, Spain
Hospital Unviersitario Virgen Nieves
Granada , 18012, Spain
Hospital Universitario HM Sanchinarro
Madrid , 28050, Spain
Ospedale Regionale Bellinzona e Valli
Bellinzona Ticino, 6500, Switzerland
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist Kaohsiung, 83301, Taiwan
Chi Mei Hospital - Liouying Branch
Tainan City Tainan, 73657, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung , 80756, Taiwan
Mackay Memorial Hospital
Taipei , 10449, Taiwan
Taipei Veterans General Hospital
Taipei , 11217, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei , 112, Taiwan
Taipei Municipal Wan Fang Hospital
Taipei , 116, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan , 333, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

560

Study ID:

NCT05654623

Recruitment Status:

Recruiting

Sponsor:


Pfizer

How clear is this clinincal trial information?

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