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.
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.
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
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There are 160 Locations for this study
Encinitas California, 92024, United States
Fresno California, 93720, United States
Napa California, 94558, United States
San Marcos California, 92069, United States
Santa Rosa California, 95403, United States
Altamonte Springs Florida, 32701, United States
Bonita Springs Florida, 34135, United States
Bradenton Florida, 34205, United States
Bradenton Florida, 34211, United States
Brandon Florida, 33511, United States
Clearwater Florida, 33756, United States
Clearwater Florida, 33761, United States
Coconut Creek Florida, 33073, United States
Daytona Beach Florida, 32117, United States
Fleming Island Florida, 32003, United States
Fort Myers Florida, 33901, United States
Fort Myers Florida, 33905, United States
Fort Myers Florida, 33908, United States
Gainesville Florida, 32605, United States
Lakeland Florida, 33805, United States
Largo Florida, 33770, United States
Lauderdale Lakes Florida, 33313, United States
Lecanto Florida, 34461, United States
Naples Florida, 34102, United States
Naples Florida, 34102, United States
Ocala Florida, 34474, United States
Orange City Florida, 32763, United States
Orange City Florida, 32763, United States
Orlando Florida, 32806, United States
Plantation Florida, 33313, United States
Plantation Florida, 33322, United States
Saint Petersburg Florida, 33705, United States
Sarasota Florida, 34232, United States
Sarasota Florida, 34236, United States
Stuart Florida, 34994, United States
Tallahassee Florida, 32308, United States
Tamarac Florida, 33321, United States
Tampa Florida, 33607, United States
The Villages Florida, 32159, United States
Trinity Florida, 34655, United States
Venice Florida, 34285, United States
Venice Florida, 34292, United States
Vero Beach Florida, 32960, United States
Wellington Florida, 33414, United States
West Palm Beach Florida, 33401, United States
Winter Park Florida, 32789, United States
Shreveport Louisiana, 71103, United States
Henderson Nevada, 89052, United States
Henderson Nevada, 89074, United States
Las Vegas Nevada, 89128, United States
Las Vegas Nevada, 89144, United States
Las Vegas Nevada, 89148, United States
Las Vegas Nevada, 89169, United States
East Syracuse New York, 13057, United States
Nyack New York, 10960, United States
Lawton Oklahoma, 73505, United States
Lawton Oklahoma, 73506, United States
Oklahoma City Oklahoma, 73102, United States
Oklahoma City Oklahoma, 73102, United States
Oklahoma City Oklahoma, 73102, United States
Dickson Tennessee, 37055, United States
Franklin Tennessee, 37067, United States
Gallatin Tennessee, 37066, United States
Hendersonville Tennessee, 37075, United States
Hermitage Tennessee, 37076, United States
Lebanon Tennessee, 37090, United States
Murfreesboro Tennessee, 37129, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37205, United States
Nashville Tennessee, 37207, United States
Nashville Tennessee, 37211, United States
Shelbyville Tennessee, 37160, United States
Smyrna Tennessee, 37167, United States
Harlingen Texas, 78550, United States
Tyler Texas, 75701, United States
Fredericksburg Virginia, 22408, United States
Birtinya Queensland, 4575, Australia
Birtinya Queensland, 4575, Australia
Hobart Tasmania, 7000, Australia
Brighton Victoria, 3186, Australia
Malvern Victoria, 3144, Australia
Woluwe-Saint-Lambert Bruxelles-capitale, Région DE, 1200, Belgium
Charleroi Hainaut, 6000, Belgium
Santo André SÃO Paulo, 09060, Brazil
Burgas , 8000, Bulgaria
Haskovo , 6300, Bulgaria
Ruse , 7002, Bulgaria
Vratsa , 3000, Bulgaria
Moncton New Brunswick, E1C 6, Canada
Kitchener Ontario, N2G 1, Canada
Hefei Anhui, 23003, China
Guangzhou Guangdong, 51006, China
Wuhan Hubei, 43002, China
Wuhan Hubei, 43007, China
Shanghai Shanghai, 20003, China
Hangzhou Zhejiang, 31001, China
Prague Praha 4, 14059, Czechia
Tampere Pirkanmaa, 33520, Finland
Pori , 28500, Finland
Dijon Côte-d'or, 21079, France
ANGERS cedex 02 Maine-et-loire, 49055, France
Berlin , 10707, Germany
Patras Achaḯa, 26504, Greece
Vijayawada Andhra Pradesh, 52000, India
Vijayawada Andhra Pradesh, 52000, India
New Delhi Delhi, 11008, India
Gurgaon Haryana, 12200, India
Nashik Maharashtra, 42200, India
Thane Maharashtra, 40110, India
Kolkata WEST Bengal, 70002, India
Zerifin Hamerkaz, 70300, Israel
Napoli Campania, 80131, Italy
Misterbianco Catania, 95045, Italy
Bologna Emilia-romagna, 40138, Italy
Roma Lazio, 00168, Italy
Monza Lombardia, 20900, Italy
Ancona Marche, 60126, Italy
Pisa Toscana, 56126, Italy
Nagoya Aichi, 464-8, Japan
Nagoya Aichi, 466-8, Japan
Nagoya Aichi, 467-8, Japan
Chiba-shi Chiba, 260-8, Japan
Kashiwa Chiba, 277-8, Japan
Sapporo Hokkaido, 003-0, Japan
Yokohama Kanagawa, 24185, Japan
Suita Osaka, 565-0, Japan
Bunkyo-ku Tokyo, 113-8, Japan
Koto Tokyo, 135-8, Japan
Shinjuku City Tokyo, 162-8, Japan
Fukuoka , 811-1, Japan
Kagoshima , 892-0, Japan
Okayama , 700-8, Japan
Namdong-gu Incheon-gwangyeoksi [incheon], 21565, Korea, Republic of
Goyang-si KyÇ’nggi-do, 10408, Korea, Republic of
Seongnam KyÇ’nggi-do, 13620, Korea, Republic of
Suwon KyÇ’nggi-do, 16499, Korea, Republic of
Seoul Seoul-teukbyeolsi [seoul], 02841, Korea, Republic of
Seoul Seoul-teukbyeolsi [seoul], 03080, Korea, Republic of
Seoul Seoul-teukbyeolsi [seoul], 03722, Korea, Republic of
Seoul Seoul-teukbyeolsi [seoul], 05505, Korea, Republic of
Seoul Seoul-teukbyeolsi [seoul], 06273, Korea, Republic of
Seoul Seoul-teukbyeolsi [seoul], 06351, Korea, Republic of
Seoul Seoul-teukbyeolsi [seoul], , Korea, Republic of
Kraków Małopolskie, 30-34, Poland
Gdansk Pomorskie, 80-21, Poland
Lodz Åódzkie, 90-33, Poland
Hato Rey , 00917, Puerto Rico
Rio Piedras , 00935, Puerto Rico
San Juan , 00927, Puerto Rico
Bratislava , 812 5, Slovakia
Kosice , 04191, Slovakia
Michalovce , 07101, Slovakia
Partizanske , 95801, Slovakia
Bloemfontein FREE State, 9301, South Africa
Johannesburg Gauteng, 2196, South Africa
Barcelona Barcelona [barcelona], 08003, Spain
Lleida Lleida [lérida], 25198, Spain
Granada , 18012, Spain
Granada , 18012, Spain
Madrid , 28050, Spain
Bellinzona Ticino, 6500, Switzerland
Kaohsiung Niao Sung Dist Kaohsiung, 83301, Taiwan
Tainan City Tainan, 73657, Taiwan
Kaohsiung , 80756, Taiwan
Taipei , 10449, Taiwan
Taipei , 11217, Taiwan
Taipei , 112, Taiwan
Taipei , 116, Taiwan
Taoyuan , 333, Taiwan
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