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A Study to Learn About a New Medicine Called ARV-471 (PF-07850327) in People Who Have Advanced Metastatic Breast Cancer. (VERITAC-2)

Primary Purpose

Advanced Breast Cancer

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ARV-471
Fulvestrant
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Breast Cancer focused on measuring ER(+)/HER2(-) Advanced Breast Cancer, Advanced cancer of the breast, Breast neoplasm, Breast tumor, Breast cancer, Fulvestrant, Estrogen receptor positive, Metastatic breast cancer, ER degrader, PROTAC, Hormone Therapy, Hormone positive breast cancer, Endocrine therapy, Recurrent breast cancer, HR+, HER2-negative, Vepdegestrant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. Only one line of CDK4/6 inhibitor is allowed in any setting. ≤ 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. This may be the endocrine treatment component of the CDK4/6 inhibitor line of therapy. 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, elacestrant, mTOR, PI3K, AKT pathway inhibitors, PARP inhibitor for any setting other investigational agents (including novel endocrine therapy any SERDs, SERCAs, CERANs) for any setting prior chemotherapy for advanced/metastatic disease Inadequate liver, kidney and bone marrow function Active brain metastases Participants with significant concomitant illness

Sites / Locations

  • CBCC Global Research, Inc.Recruiting
  • Comprehensive Blood and Cancer CenterRecruiting
  • California Cancer Associates for Research and Excellence, Inc. (cCARE)Recruiting
  • California Cancer Associates for Research and ExcellenceRecruiting
  • Providence Queen of the Valley Medical CenterRecruiting
  • California Cancer Associates for Research and ExcellenceRecruiting
  • Providence Medical FoundationRecruiting
  • Olive View-UCLA Medical Center
  • TMPN Cancer Care research office
  • Torrance Memorial Physician Network / Cancer Care
  • Florida cancer specialistsRecruiting
  • Florida Cancer Specialists BONRecruiting
  • Florida Cancer Specialists BCCRecruiting
  • Florida Cancer Specialists LRSRecruiting
  • Florida Cancer SpecialistsRecruiting
  • Florida Cancer Specialists NFMRecruiting
  • Morton Plant Hospital - BayCare Health SystemRecruiting
  • Florida Cancer SpecialistsRecruiting
  • 3T Radiology LLCRecruiting
  • Florida Cancer SpecialistsRecruiting
  • Florida Cancer SpecialistsRecruiting
  • Florida Cancer Specialists - SouthRecruiting
  • Florida Cancer Specialists COLRecruiting
  • Florida Cancer Specialists GLORecruiting
  • Florida Cancer SpecialistsRecruiting
  • Lakeland Regional Cancer CenterRecruiting
  • Florida Cancer SpecialistsRecruiting
  • Broward P.E.T. Imaging CenterRecruiting
  • Florida Cancer SpecialistsRecruiting
  • Florida Cancer Specialists NGDRecruiting
  • Florida Cancer Specialists NPWRecruiting
  • Florida Cancer SpecialistsRecruiting
  • Florida Cancer specialistsRecruiting
  • Mid Florida Hematology and Oncology CenterRecruiting
  • Florida Cancer SpecialistsRecruiting
  • POM MRI & Radiology CentersRecruiting
  • BRCR GlobalRecruiting
  • Florida Cancer Specialists PCHRecruiting
  • Florida Cancer SpecialistsRecruiting
  • Florida Cancer Specialists SACRecruiting
  • Florida Cancer Specialists SADRecruiting
  • Florida Cancer SpecialistsRecruiting
  • Florida Cancer SpecialistsRecruiting
  • Impression ImagingRecruiting
  • Florida Cancer SpecialistsRecruiting
  • Florida Cancer SpecialistsRecruiting
  • Florida Cancer SpecialistRecruiting
  • Florida Cancer Specialists VISRecruiting
  • Florida Cancer Specialists VHPRecruiting
  • Florida Cancer SpecialistsRecruiting
  • Florida Cancer SpecialistsRecruiting
  • Florida Cancer SpecialistsRecruiting
  • Florida Cancer SpecialistsRecruiting
  • Norton Cancer Institute - DowntownRecruiting
  • Norton Cancer Institute, DowntownRecruiting
  • Norton HospitalRecruiting
  • Norton Cancer Institute, St Matthews CampusRecruiting
  • Norton Women's & Children's HospitalRecruiting
  • Norton Brownsboro HospitalRecruiting
  • Norton Cancer Institute, Brownsboro Hospital CampusRecruiting
  • University Medical Center New OrleansRecruiting
  • Louisiana State University Health Sciences ShreveportRecruiting
  • Hattiesburg Clinic Hematology/OncologyRecruiting
  • Comprehensive Cancer Centers of NevadaRecruiting
  • Comprehensive Cancer Centers of NevadaRecruiting
  • Comprehensive Cancer Centers of NevadaRecruiting
  • Comprehensive Cancer Centers of NevadaRecruiting
  • Comprehensive Cancer Centers of NevadaRecruiting
  • Comprehensive Cancer Centers of NevadaRecruiting
  • Dartmouth-Hitchcock Medical Center
  • Astera Cancer CareRecruiting
  • Hematology-Oncology Associates of Central New York, PCRecruiting
  • Hematology Oncology Associates of RocklandRecruiting
  • Cancer Centers of Southwest OklahomaRecruiting
  • Cancer Centers of Southwest OklahomaRecruiting
  • Frank C Love Cancer InstituteRecruiting
  • Hightower Clinical Trial ServicesRecruiting
  • SSM Health Medical Group - St AnthonyRecruiting
  • Tennessee Oncology, PLLCRecruiting
  • Tennessee Oncology PLLCRecruiting
  • Tennessee Oncology PLLCRecruiting
  • Tennessee Oncology PLLCRecruiting
  • Tennessee Oncology PLLCRecruiting
  • Tennessee Oncology PLLCRecruiting
  • Tennessee Oncology PLLCRecruiting
  • Tennessee Oncology PLLCRecruiting
  • Tennessee Oncology, PLLCRecruiting
  • Tennessee Oncology PLLCRecruiting
  • Tennessee Oncology PLLCRecruiting
  • Tennessee Oncology PLLCRecruiting
  • Tennessee Oncology, PLLCRecruiting
  • Tennessee Oncology PLLCRecruiting
  • Valley Cancer AssociatesRecruiting
  • The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer CenterRecruiting
  • Hematology Oncology Associates of FredericksburgRecruiting
  • West Virginia University
  • Centro Oncologico Korben
  • Sunshine Coast University Private Hospital
  • Sunshine Coast University Private HospitalRecruiting
  • Icon Cancer Centre HobartRecruiting
  • Cabrini Hospital -BrightonRecruiting
  • Barwon HealthRecruiting
  • Cabrini Hospital - MalvernRecruiting
  • Cliniques universitaires Saint-Luc
  • Grand Hôpital de Charleroi
  • UZ Leuven
  • Hospital Santa Rita de CassiaRecruiting
  • ONCOSITE - Centro de Pesquisa Clinica em Oncologia
  • Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E PesquisaRecruiting
  • Centro de Pesquisa Clínica - Área AdministrativaRecruiting
  • Hospital Mae de DeusRecruiting
  • Faculdade de Medicina do ABCRecruiting
  • A. C. Camargo Cancer CenterRecruiting
  • IBCC - Instituto Brasileiro de Controle do CâncerRecruiting
  • Núcleo de Pesquisa Clínica da Rede São CamiloRecruiting
  • Complex Oncology Center - BurgasRecruiting
  • Multiprofile Hospital for Active Treatment Dr. Tota Venkova ADRecruiting
  • Specialized Hospital for Active Treatment of Oncology - HaskovoRecruiting
  • Complex Oncology Center - Plovdiv EOODRecruiting
  • Complex Oncology Center - Ruse EOODRecruiting
  • Complex Oncology Center - VratsaRecruiting
  • The Moncton HospitalRecruiting
  • Grand River HospitalRecruiting
  • Sunnybrook Research Institute
  • Sunnybrook Research InstituteRecruiting
  • Unité de Recherche Clinique du CISSS des LaurentidesRecruiting
  • Anhui Provincial Hospital
  • Anhui Provincial Cancer HospitalRecruiting
  • Fujian Medical University Union Hospital-1 Bingfanglou
  • Sun Yat-sen University Cancer CenterRecruiting
  • Guangxi Medical University Affiliated Tumor HospitalRecruiting
  • Wuhan Union Hospital Cancer CenterRecruiting
  • Hubei Cancer HospitalRecruiting
  • The Second Affiliated Hospital of Soochow UniversityRecruiting
  • The First Affiliated Hospital of Nanchang UniversityRecruiting
  • The Second Affiliated Hospital of Xi'an Jiaotong University
  • The Second Affiliated Hospital of Xi'an Jiaotong University
  • Fudan University Shanghai Cancer CenterRecruiting
  • Sir Run Run Shaw Hospital of Zhejiang University School of MedicineRecruiting
  • Zhejiang Cancer Hospital
  • The Second Affiliated hospital of Zhejiang University school of medicineRecruiting
  • Henan Cancer HospitalRecruiting
  • Fakultni Thomayerova nemocniceRecruiting
  • Fakultni nemocnice BulovkaRecruiting
  • Fakultni nemocnice OlomoucRecruiting
  • Fakultni nemocnice Kralovske VinohradyRecruiting
  • Tampereen yliopistollinen sairaala
  • Vaasan Keskussairaala
  • Oulun yliopistollinen sairaala
  • Satakunnan Keskussairaala
  • Centre Georges François LeclercRecruiting
  • Institut de Cancérologie de l'OuestRecruiting
  • Institut de Cancérologie de l'OuestRecruiting
  • Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'AuvergneRecruiting
  • Centre Hospitalier Universitaire de PoitiersRecruiting
  • Henri Mondor HospitalRecruiting
  • Gynäkologie Kompetenzzentrum Stralsund
  • Onkologische Schwerpunktpraxis KurfuerstendammRecruiting
  • University Hospital of Patras
  • Alexandra General Hospital of Athens
  • Attikon General University Hospital
  • University General Hospital of Heraklion
  • University General Hospital of Larissa
  • City Cancer Centre - VijayawadaRecruiting
  • Hcg Pet Imaging CentreRecruiting
  • All India Institute of Medical Sciences
  • Rajiv Gandhi Cancer Institute And Research CentreRecruiting
  • Artemis hospitalRecruiting
  • HCG Manavata Cancer CentreRecruiting
  • Sahyadri Super Speciality Hospital, Hadapsar
  • Bhakti Vedanta Hospital and Research InstituteRecruiting
  • Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial HospitalRecruiting
  • Rabin Medical Center
  • Kaplan Medical CenterRecruiting
  • Yitzhak Shamir Medical CenterRecruiting
  • Istituto Nazionale Tumori IRCCS Fondazione PascaleRecruiting
  • Humanitas Istituto Clinico CataneseRecruiting
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'OrsolaRecruiting
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro CuorRecruiting
  • Fondazione IRCCS San Gerardo dei TintoriRecruiting
  • Azienda Ospedaliero Universitaria delle MarcheRecruiting
  • Azienda Ospedaliero Universitaria PisanaRecruiting
  • Ospedale Generale Provinciale MacerataRecruiting
  • Istituto Europeo di Oncologia IRCCSRecruiting
  • Istituto Oncologico Veneto IRCCS
  • Aichi Cancer Center HospitalRecruiting
  • Nagoya University HospitalRecruiting
  • Nagoya City University HospitalRecruiting
  • Chiba cancer centerRecruiting
  • National Cancer Center Hospital EastRecruiting
  • National Hospital Organization Hokkaido Cancer CenterRecruiting
  • Kanagawa cancer centerRecruiting
  • Osaka University HospitalRecruiting
  • Saitama Prefectural Cancer CenterRecruiting
  • Juntendo University HospitalRecruiting
  • Tokyo Metropolitan Komagome Hospital, Department of Breast SurgeryRecruiting
  • Japanese Foundation for Cancer ResearchRecruiting
  • National Center for Global Health and MedicineRecruiting
  • National Hospital Organization Kyushu Cancer CenterRecruiting
  • Sagara HospitalRecruiting
  • Okayama University HospitalRecruiting
  • Juntendo University HospitalRecruiting
  • Gachon University Gil Medical CenterRecruiting
  • National Cancer CenterRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • Ajou University HospitalRecruiting
  • Korea University Anam HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • Asan Medical CenterRecruiting
  • Gangnam Severance Hospital, Yonsei University Health SystemRecruiting
  • Samsung Medical CenterRecruiting
  • The Catholic Univ. of Korea Seoul St. Mary's HospitalRecruiting
  • Ewha Womans University Mokdong HospitalRecruiting
  • Akershus Universitetssykehus
  • Drammen Sykehus, Vestre Viken HF
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
  • Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.Recruiting
  • KLIMED Marek KlimkiewiczRecruiting
  • COPERNICUS PL, Wojewodzkie Centrum OnkologiiRecruiting
  • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-AkcyjnaRecruiting
  • Puerto Rico Medical Research CenterRecruiting
  • Pan American Center for Oncology Trials- Hospital OncologicoRecruiting
  • FDI Clinical ResearchRecruiting
  • Onkologicky ustav sv. Alzbety, s.r.o.Recruiting
  • Narodny onkologicky ustavRecruiting
  • Vychodoslovensky onkologicky ustav, a.s.Recruiting
  • Nemocnica s poliklinikou Stefana Kukuru Michalovce, a.s.Recruiting
  • Nemocnica na okraji mesta n oRecruiting
  • Fakultna nemocnica s poliklinikou J.A. Reimana PresovRecruiting
  • Fakultna nemocnica TrnavaRecruiting
  • Iatros International
  • Wits Clinical Research
  • Medical Oncology Centre of RosebankRecruiting
  • Cancercare Rondebosch Oncology
  • CHUAC-Hospital Teresa HerreraRecruiting
  • Hospital General Universitario de ElcheRecruiting
  • Institut Català d'Oncologia (ICO) - BadalonaRecruiting
  • Parc de Salut Mar - Hospital del MarRecruiting
  • Institut Català d'Oncologia - L'HospitaletRecruiting
  • Hospital Universitario DonostiaRecruiting
  • Hospital Universitario Arnau de Vilanova de LleidaRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Hospital Universitario Virgen de la VictoriaRecruiting
  • Osi Bilbao-BasurtoRecruiting
  • Hospital Universitario Virgen NievesRecruiting
  • Hospital Unviersitario Virgen NievesRecruiting
  • Hospital Clinico San CarlosRecruiting
  • Hospital Universitario La PazRecruiting
  • Hospital Universitario HM Sanchinarro
  • Althaia, Xarxa Assistencial Universitària de ManresaRecruiting
  • Sundsvalls Sjukhus
  • Tumor Zentrum AarauRecruiting
  • Kantonsspital Graubünden
  • Kantonsspital Frauenfeld - Spital Thurgau AGRecruiting
  • Kantonsspital Münsterlingen - Spital Thurgau AGRecruiting
  • Ospedale Regionale Bellinzona e ValliRecruiting
  • Kantonsspital WinterthurRecruiting
  • Changhua Christian HospitalRecruiting
  • Chang Gung Memorial Hospital at KaohsiungRecruiting
  • Chi Mei Medical CenterRecruiting
  • Chi Mei Hospital - Liouying BranchRecruiting
  • Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
  • China Medical University HospitalRecruiting
  • National Cheng Kung University Hospital
  • National Cheng Kung University HospitalRecruiting
  • National Taiwan University HospitalRecruiting
  • Mackay Memorial HospitalRecruiting
  • Taipei Veterans General HospitalRecruiting
  • Koo Foundation Sun Yat-Sen Cancer CenterRecruiting
  • Taipei Municipal Wan Fang HospitalRecruiting
  • Chang Gung Medical Foundation-Linkou BranchRecruiting
  • Memorial Ankara Hastanesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ARV-471

Fulvestrant

Arm Description

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)
Progression-free survival is defined as the time interval from the date of randomization to the date of first documented tumor progression determined by blinded independent central review (BICR) assessment as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or death due to any cause, whichever come first.

Secondary Outcome Measures

Overall survival (OS)
Overall survival is defined as the time interval from the date of randomization to the date of documented death due to any cause.
Objective Response Rate (ORR)
Objective response rate is defined as the proportion of participants who have a confirmed CR or PR, as best overall response assessed by BICR as per RECIST 1.1, from the date of randomization to the date of disease progression, death due to any cause, whichever occurs first.
Duration of response (DR)
Duration of response is defined as the time from first documented evidence of CR or PR until progressive disease (PD) as determined by BICR assessment as per RECIST 1.1 or death due to any cause, whichever occurs first.
Clinical Benefit Rate
Clinical benefit rate is defined as the proportion of participants who have a confirmed CR, PR at any time, or SD or nonCR/non PD for at least 24 weeks determined by BICR assessment as per RECIST 1.1, from the date of randomization until disease progression, death due to any cause, whichever occurs first.
Number of participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs), electrocardiogram (ECG) and laboratory abnormalities
Incidence of participants with TEAEs, SAEs ECGs and laboratory abnormalities. TEAE/SAE and laboratory abnormalities will be graded according to NCI CTCAE V5.
QT Interval (QTc)
Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) are performed.
Plasma Concentration Versus Time of ARV-471
Plasma concentrations of ARV-471
Health state utility and health status will be assessed using the European Quality of Life Group questionnaire with 5 dimensions and 5 levels per dimension (EQ-5D-5L)
Change from baseline and time to deterioration between treatment comparison in Quality of Life using the EQ-5D 5L questionnaire.
Disease-related Quality of Life will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30)
Change from baseline and time to deterioration between treatment comparison in Quality of Life using the EORTC QLQ-C30 questionnaire.
Disease- and treatment-related Quality of Life will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) breast cancer module (QLQ-BR23) questionnaire
Change from baseline and time to deterioration between treatment comparison in Quality of Life Using the EORTC QLQ-BR23 (Breast) questionnaire.
Clinical Pain and its impact on functioning will be assessed using Brief Pain Inventory Short Form (BPI-SF) questionnaire.
Change from baseline and time to deterioration between treatment comparison in Brief Pain Inventory Short Form questionnaire.
circulating deoxyribonucleic acid (DNA)
Quantitative changes from baseline

Full Information

First Posted
November 16, 2022
Last Updated
September 19, 2023
Sponsor
Pfizer
Collaborators
Arvinas Estrogen Receptor, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05654623
Brief Title
A Study to Learn About a New Medicine Called ARV-471 (PF-07850327) in People Who Have Advanced Metastatic Breast Cancer.
Acronym
VERITAC-2
Official Title
A PHASE 3, RANDOMIZED, OPEN-LABEL, MULTICENTER TRIAL OF ARV-471 (PF-07850327) VS FULVESTRANT IN PARTICIPANTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR ENDOCRINE BASED TREATMENT FOR ADVANCED DISEASE (VERITAC-2)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2023 (Actual)
Primary Completion Date
August 14, 2024 (Anticipated)
Study Completion Date
May 15, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
Arvinas Estrogen Receptor, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A study to learn about a new medicine called ARV-471 (PF-07850327) in people who have advanced metastatic breast cancer.
Detailed Description
The purpose of this study is to learn about the safety and effects of the study medicine ARV-471 (PF-07850327, vepdegestrant) compared to fulvestrant (FUL) in participants with advanced breast cancer. Advanced breast cancer is difficult to cure or control with treatment. The cancer may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body, i.e. bones, lungs, brain, or liver. 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 cancer that has come back in the place where it started or spread to nearby tissue, lymph nodes, or distant parts of the body. cannot be fully cured by surgery or radiation therapy. Radiation therapy is the use of high-energy radiation such as x-rays, gamma rays and other sources to kill cancer cells and shrink tumors. respond to hormonal or endocrine therapy (which target hormones and/or activity of hormone receptors) such as tamoxifen or aromatase inhibitors (this is called estrogen receptor positive disease) have received one line of CDK4/6 inhibitor therapy (for example palbociclib, ribociclib or abemaciclib) in combination with endocrine therapy (for example letrozole) for advanced cancer. are allowed up to one other endocrine therapy (for example exemestane) for advanced cancer. Half of the participants will be given ARV-471 while the other half of the participants will be given FUL. Participants who get ARV-471 will take ARV-471 by mouth with food, one time a day. During the first treatment cycle participants who will get FUL will be given FUL by shots into the muscles on Day 1 and again 2 weeks later. After the first month, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Breast Cancer
Keywords
ER(+)/HER2(-) Advanced Breast Cancer, Advanced cancer of the breast, Breast neoplasm, Breast tumor, Breast cancer, Fulvestrant, Estrogen receptor positive, Metastatic breast cancer, ER degrader, PROTAC, Hormone Therapy, Hormone positive breast cancer, Endocrine therapy, Recurrent breast cancer, HR+, HER2-negative, Vepdegestrant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
560 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ARV-471
Arm Type
Experimental
Arm Title
Fulvestrant
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
ARV-471
Other Intervention Name(s)
PF-07850327
Intervention Description
orally, once daily on a 28-day continuous dosing schedule
Intervention Type
Drug
Intervention Name(s)
Fulvestrant
Intervention Description
intramuscularly on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle starting from C2D1 (28-day cycle)
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
Progression-free survival is defined as the time interval from the date of randomization to the date of first documented tumor progression determined by blinded independent central review (BICR) assessment as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or death due to any cause, whichever come first.
Time Frame
From randomization date (every 8 weeks for the first 48 weeks and then every 12 weeks thereafter) to date of first documentation of progression OR death (approximately 2 years).
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
Overall survival is defined as the time interval from the date of randomization to the date of documented death due to any cause.
Time Frame
From randomization date (every 3 months) to date of death (approximately 3 years)
Title
Objective Response Rate (ORR)
Description
Objective response rate is defined as the proportion of participants who have a confirmed CR or PR, as best overall response assessed by BICR as per RECIST 1.1, from the date of randomization to the date of disease progression, death due to any cause, whichever occurs first.
Time Frame
From randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) to the date of progression OR death (approximately to 2 years).
Title
Duration of response (DR)
Description
Duration of response is defined as the time from first documented evidence of CR or PR until progressive disease (PD) as determined by BICR assessment as per RECIST 1.1 or death due to any cause, whichever occurs first.
Time Frame
From the date of the first objective response (every 8 weeks during the first 48 weeks and then every 12 week) to the date of disease progression or death (approximately to 2 years).
Title
Clinical Benefit Rate
Description
Clinical benefit rate is defined as the proportion of participants who have a confirmed CR, PR at any time, or SD or nonCR/non PD for at least 24 weeks determined by BICR assessment as per RECIST 1.1, from the date of randomization until disease progression, death due to any cause, whichever occurs first.
Time Frame
From randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) to the date of progression or death (approximately to 2 years).
Title
Number of participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs), electrocardiogram (ECG) and laboratory abnormalities
Description
Incidence of participants with TEAEs, SAEs ECGs and laboratory abnormalities. TEAE/SAE and laboratory abnormalities will be graded according to NCI CTCAE V5.
Time Frame
From screening until 28 days after the last dose (approximately 2 years).
Title
QT Interval (QTc)
Description
Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) are performed.
Time Frame
From baseline to end of treatment (approximately 2 years).
Title
Plasma Concentration Versus Time of ARV-471
Description
Plasma concentrations of ARV-471
Time Frame
From randomization date up to cycle 7 (each cycle is 28 days).
Title
Health state utility and health status will be assessed using the European Quality of Life Group questionnaire with 5 dimensions and 5 levels per dimension (EQ-5D-5L)
Description
Change from baseline and time to deterioration between treatment comparison in Quality of Life using the EQ-5D 5L questionnaire.
Time Frame
From screening and every cycle until cycle 6 (each cycle is 28 days), and then every other cycle until 28 days after the last dose (approximately 2 years).
Title
Disease-related Quality of Life will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30)
Description
Change from baseline and time to deterioration between treatment comparison in Quality of Life using the EORTC QLQ-C30 questionnaire.
Time Frame
From screening and every cycle until cycle 6 (each cycle is 28 days), and then every other cycle until 28 days after the last dose (approximately 2 years).
Title
Disease- and treatment-related Quality of Life will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) breast cancer module (QLQ-BR23) questionnaire
Description
Change from baseline and time to deterioration between treatment comparison in Quality of Life Using the EORTC QLQ-BR23 (Breast) questionnaire.
Time Frame
From screening and every cycle until cycle 6 (each cycle is 28 days), and then every other cycle until 28 days after the last dose (approximately 2 years).
Title
Clinical Pain and its impact on functioning will be assessed using Brief Pain Inventory Short Form (BPI-SF) questionnaire.
Description
Change from baseline and time to deterioration between treatment comparison in Brief Pain Inventory Short Form questionnaire.
Time Frame
From screening and every cycle until cycle 6 (cycle=28 days) and then every other cycle until 28 days after the last dose (appr. 2 yrs).The modified BPI-SF (worst pain severity and pain interference) daily from baseline until the EOT (appr 2 yrs)
Title
circulating deoxyribonucleic acid (DNA)
Description
Quantitative changes from baseline
Time Frame
From baseline to end of treatment (approximately 2 years).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. Only one line of CDK4/6 inhibitor is allowed in any setting. ≤ 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. This may be the endocrine treatment component of the CDK4/6 inhibitor line of therapy. 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, elacestrant, mTOR, PI3K, AKT pathway inhibitors, PARP inhibitor for any setting other investigational agents (including novel endocrine therapy any SERDs, SERCAs, CERANs) for any setting prior chemotherapy for advanced/metastatic disease Inadequate liver, kidney and bone marrow function Active brain metastases Participants with significant concomitant illness
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
CBCC Global Research, Inc.
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Individual Site Status
Recruiting
Facility Name
Comprehensive Blood and Cancer Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Individual Site Status
Recruiting
Facility Name
California Cancer Associates for Research and Excellence, Inc. (cCARE)
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Individual Site Status
Recruiting
Facility Name
California Cancer Associates for Research and Excellence
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Individual Site Status
Recruiting
Facility Name
Providence Queen of the Valley Medical Center
City
Napa
State/Province
California
ZIP/Postal Code
94558
Country
United States
Individual Site Status
Recruiting
Facility Name
California Cancer Associates for Research and Excellence
City
San Marcos
State/Province
California
ZIP/Postal Code
92069
Country
United States
Individual Site Status
Recruiting
Facility Name
Providence Medical Foundation
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Individual Site Status
Recruiting
Facility Name
Olive View-UCLA Medical Center
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
TMPN Cancer Care research office
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Torrance Memorial Physician Network / Cancer Care
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Florida cancer specialists
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists BON
City
Bonita Springs
State/Province
Florida
ZIP/Postal Code
34135
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists BCC
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists LRS
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34211
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists NFM
City
Cape Coral
State/Province
Florida
ZIP/Postal Code
33909
Country
United States
Individual Site Status
Recruiting
Facility Name
Morton Plant Hospital - BayCare Health System
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Individual Site Status
Recruiting
Facility Name
3T Radiology LLC
City
Coconut Creek
State/Province
Florida
ZIP/Postal Code
33073
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists
City
Fleming Island
State/Province
Florida
ZIP/Postal Code
32003
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists - South
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists COL
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33905
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists GLO
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Individual Site Status
Recruiting
Facility Name
Lakeland Regional Cancer Center
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Individual Site Status
Recruiting
Facility Name
Broward P.E.T. Imaging Center
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33313
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists
City
Lecanto
State/Province
Florida
ZIP/Postal Code
34461
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists NGD
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists NPW
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer specialists
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Individual Site Status
Recruiting
Facility Name
Mid Florida Hematology and Oncology Center
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Name
POM MRI & Radiology Centers
City
Plantation
State/Province
Florida
ZIP/Postal Code
33313
Country
United States
Individual Site Status
Recruiting
Facility Name
BRCR Global
City
Plantation
State/Province
Florida
ZIP/Postal Code
33322
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists PCH
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33980
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists SAC
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists SAD
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34236
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists
City
Stuart
State/Province
Florida
ZIP/Postal Code
34994
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Individual Site Status
Recruiting
Facility Name
Impression Imaging
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists
City
The Villages
State/Province
Florida
ZIP/Postal Code
32159
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialist
City
Trinity
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists VIS
City
Venice
State/Province
Florida
ZIP/Postal Code
34285
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists VHP
City
Venice
State/Province
Florida
ZIP/Postal Code
34292
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Individual Site Status
Recruiting
Facility Name
Norton Cancer Institute - Downtown
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Name
Norton Cancer Institute, Downtown
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Name
Norton Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Name
Norton Cancer Institute, St Matthews Campus
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Individual Site Status
Recruiting
Facility Name
Norton Women's & Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Individual Site Status
Recruiting
Facility Name
Norton Brownsboro Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Individual Site Status
Recruiting
Facility Name
Norton Cancer Institute, Brownsboro Hospital Campus
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Individual Site Status
Recruiting
Facility Name
University Medical Center New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Name
Louisiana State University Health Sciences Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Individual Site Status
Recruiting
Facility Name
Hattiesburg Clinic Hematology/Oncology
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Individual Site Status
Recruiting
Facility Name
Comprehensive Cancer Centers of Nevada
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Individual Site Status
Recruiting
Facility Name
Comprehensive Cancer Centers of Nevada
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
Individual Site Status
Recruiting
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Individual Site Status
Recruiting
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Individual Site Status
Recruiting
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Individual Site Status
Recruiting
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Individual Site Status
Recruiting
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Astera Cancer Care
City
East Brunswick
State/Province
New Jersey
ZIP/Postal Code
08816
Country
United States
Individual Site Status
Recruiting
Facility Name
Hematology-Oncology Associates of Central New York, PC
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Individual Site Status
Recruiting
Facility Name
Hematology Oncology Associates of Rockland
City
Nyack
State/Province
New York
ZIP/Postal Code
10960
Country
United States
Individual Site Status
Recruiting
Facility Name
Cancer Centers of Southwest Oklahoma
City
Lawton
State/Province
Oklahoma
ZIP/Postal Code
73505
Country
United States
Individual Site Status
Recruiting
Facility Name
Cancer Centers of Southwest Oklahoma
City
Lawton
State/Province
Oklahoma
ZIP/Postal Code
73506
Country
United States
Individual Site Status
Recruiting
Facility Name
Frank C Love Cancer Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73102
Country
United States
Individual Site Status
Recruiting
Facility Name
Hightower Clinical Trial Services
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73102
Country
United States
Individual Site Status
Recruiting
Facility Name
SSM Health Medical Group - St Anthony
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73102
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennessee Oncology, PLLC
City
Dickson
State/Province
Tennessee
ZIP/Postal Code
37055
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennessee Oncology PLLC
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennessee Oncology PLLC
City
Gallatin
State/Province
Tennessee
ZIP/Postal Code
37066
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennessee Oncology PLLC
City
Hendersonville
State/Province
Tennessee
ZIP/Postal Code
37075
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennessee Oncology PLLC
City
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37076
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennessee Oncology PLLC
City
Lebanon
State/Province
Tennessee
ZIP/Postal Code
37090
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennessee Oncology PLLC
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37129
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennessee Oncology PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennessee Oncology PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennessee Oncology PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37207
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennessee Oncology PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennessee Oncology, PLLC
City
Shelbyville
State/Province
Tennessee
ZIP/Postal Code
37160
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennessee Oncology PLLC
City
Smyrna
State/Province
Tennessee
ZIP/Postal Code
37167
Country
United States
Individual Site Status
Recruiting
Facility Name
Valley Cancer Associates
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Individual Site Status
Recruiting
Facility Name
Hematology Oncology Associates of Fredericksburg
City
Fredericksburg
State/Province
Virginia
ZIP/Postal Code
22408
Country
United States
Individual Site Status
Recruiting
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Centro Oncologico Korben
City
Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Sunshine Coast University Private Hospital
City
Birtinya
State/Province
Queensland
ZIP/Postal Code
4575
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Sunshine Coast University Private Hospital
City
Birtinya
State/Province
Queensland
ZIP/Postal Code
4575
Country
Australia
Individual Site Status
Recruiting
Facility Name
Icon Cancer Centre Hobart
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Cabrini Hospital -Brighton
City
Brighton
State/Province
Victoria
ZIP/Postal Code
3186
Country
Australia
Individual Site Status
Recruiting
Facility Name
Barwon Health
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Individual Site Status
Recruiting
Facility Name
Cabrini Hospital - Malvern
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Individual Site Status
Recruiting
Facility Name
Cliniques universitaires Saint-Luc
City
Woluwe-Saint-Lambert
State/Province
Bruxelles-capitale, Région DE
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Grand Hôpital de Charleroi
City
Charleroi
State/Province
Hainaut
ZIP/Postal Code
6000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams-brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Hospital Santa Rita de Cassia
City
Vitoria
State/Province
Espírito Santo
ZIP/Postal Code
29041-295
Country
Brazil
Individual Site Status
Recruiting
Facility Name
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
City
Ijui
State/Province
RIO Grande DO SUL
ZIP/Postal Code
98700-000
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90110-270
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Centro de Pesquisa Clínica - Área Administrativa
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90850-170
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Mae de Deus
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90880-480
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Faculdade de Medicina do ABC
City
Santo André
State/Province
SÃO Paulo
ZIP/Postal Code
09060-650
Country
Brazil
Individual Site Status
Recruiting
Facility Name
A. C. Camargo Cancer Center
City
Sao Paulo
State/Province
SÃO Paulo
ZIP/Postal Code
01509-010
Country
Brazil
Individual Site Status
Recruiting
Facility Name
IBCC - Instituto Brasileiro de Controle do Câncer
City
São Paulo
ZIP/Postal Code
03102002
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Núcleo de Pesquisa Clínica da Rede São Camilo
City
São Paulo
ZIP/Postal Code
04014-002
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Complex Oncology Center - Burgas
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Multiprofile Hospital for Active Treatment Dr. Tota Venkova AD
City
Gabrovo
ZIP/Postal Code
5300
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Specialized Hospital for Active Treatment of Oncology - Haskovo
City
Haskovo
ZIP/Postal Code
6300
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Complex Oncology Center - Plovdiv EOOD
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Complex Oncology Center - Ruse EOOD
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Complex Oncology Center - Vratsa
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
The Moncton Hospital
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Grand River Hospital
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2G 1G3
Country
Canada
Individual Site Status
Recruiting
Facility Name
Sunnybrook Research Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Sunnybrook Research Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Unité de Recherche Clinique du CISSS des Laurentides
City
St-Jerome
State/Province
Quebec
ZIP/Postal Code
J7Z 5T3
Country
Canada
Individual Site Status
Recruiting
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Anhui Provincial Cancer Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230031
Country
China
Individual Site Status
Recruiting
Facility Name
Fujian Medical University Union Hospital-1 Bingfanglou
City
Fuzhou Fujian
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Name
Guangxi Medical University Affiliated Tumor Hospital
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting
Facility Name
Wuhan Union Hospital Cancer Center
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi/china
ZIP/Postal Code
710004
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The Second Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710004
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Name
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Individual Site Status
Recruiting
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The Second Affiliated hospital of Zhejiang University school of medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310052
Country
China
Individual Site Status
Recruiting
Facility Name
Henan Cancer Hospital
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Name
Fakultni Thomayerova nemocnice
City
Prague
State/Province
Praha 4
ZIP/Postal Code
14059
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Bulovka
City
Prague
State/Province
Praha 8
ZIP/Postal Code
180 81
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Kralovske Vinohrady
City
Praha 10
ZIP/Postal Code
10034
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Tampereen yliopistollinen sairaala
City
Tampere
State/Province
Pirkanmaa
ZIP/Postal Code
33520
Country
Finland
Individual Site Status
Not yet recruiting
Facility Name
Vaasan Keskussairaala
City
Vaasa
State/Province
Pohjanmaa
ZIP/Postal Code
65130
Country
Finland
Individual Site Status
Not yet recruiting
Facility Name
Oulun yliopistollinen sairaala
City
Oulu
State/Province
Pohjois-pohjanmaa
ZIP/Postal Code
90220
Country
Finland
Individual Site Status
Not yet recruiting
Facility Name
Satakunnan Keskussairaala
City
Pori
ZIP/Postal Code
28500
Country
Finland
Individual Site Status
Not yet recruiting
Facility Name
Centre Georges François Leclerc
City
Dijon
State/Province
Côte-d'or
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Name
Institut de Cancérologie de l'Ouest
City
Saint Herblain
State/Province
Loire-atlantique
ZIP/Postal Code
44805
Country
France
Individual Site Status
Recruiting
Facility Name
Institut de Cancérologie de l'Ouest
City
ANGERS cedex 02
State/Province
Maine-et-loire
ZIP/Postal Code
49055
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
City
Clermont-Ferrand
State/Province
Puy-de-dôme
ZIP/Postal Code
63011
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Poitiers
City
Poitiers
State/Province
Vienne
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Name
Henri Mondor Hospital
City
Créteil
State/Province
Île-de-france
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Name
Gynäkologie Kompetenzzentrum Stralsund
City
Stralsund
State/Province
Mecklenburg-vorpommern
ZIP/Postal Code
18439
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Onkologische Schwerpunktpraxis Kurfuerstendamm
City
Berlin
ZIP/Postal Code
10707
Country
Germany
Individual Site Status
Recruiting
Facility Name
University Hospital of Patras
City
Patras
State/Province
Achaḯa
ZIP/Postal Code
26504
Country
Greece
Individual Site Status
Not yet recruiting
Facility Name
Alexandra General Hospital of Athens
City
Athens
State/Province
Attikí
ZIP/Postal Code
115 28
Country
Greece
Individual Site Status
Not yet recruiting
Facility Name
Attikon General University Hospital
City
Chaidari/Athens
State/Province
Attikí
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Not yet recruiting
Facility Name
University General Hospital of Heraklion
City
Heraklion
State/Province
Irakleío
ZIP/Postal Code
715 00
Country
Greece
Individual Site Status
Not yet recruiting
Facility Name
University General Hospital of Larissa
City
Larissa
State/Province
Thessalía
ZIP/Postal Code
41110
Country
Greece
Individual Site Status
Not yet recruiting
Facility Name
City Cancer Centre - Vijayawada
City
Vijayawada
State/Province
Andhra Pradesh
ZIP/Postal Code
520002
Country
India
Individual Site Status
Recruiting
Facility Name
Hcg Pet Imaging Centre
City
Vijayawada
State/Province
Andhra Pradesh
ZIP/Postal Code
520002
Country
India
Individual Site Status
Recruiting
Facility Name
All India Institute of Medical Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Rajiv Gandhi Cancer Institute And Research Centre
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110085
Country
India
Individual Site Status
Recruiting
Facility Name
Artemis hospital
City
Gurgaon
State/Province
Haryana
ZIP/Postal Code
122001
Country
India
Individual Site Status
Recruiting
Facility Name
HCG Manavata Cancer Centre
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422002
Country
India
Individual Site Status
Recruiting
Facility Name
Sahyadri Super Speciality Hospital, Hadapsar
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411028
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Bhakti Vedanta Hospital and Research Institute
City
Thane
State/Province
Maharashtra
ZIP/Postal Code
401107
Country
India
Individual Site Status
Recruiting
Facility Name
Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
City
Kolkata
State/Province
WEST Bengal
ZIP/Postal Code
700020
Country
India
Individual Site Status
Recruiting
Facility Name
Rabin Medical Center
City
Petah Tikva
State/Province
Hamerkaz
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Kaplan Medical Center
City
Rehovot
State/Province
Hamerkaz
ZIP/Postal Code
7610001
Country
Israel
Individual Site Status
Recruiting
Facility Name
Yitzhak Shamir Medical Center
City
Zerifin
State/Province
Hamerkaz
ZIP/Postal Code
70300
Country
Israel
Individual Site Status
Recruiting
Facility Name
Istituto Nazionale Tumori IRCCS Fondazione Pascale
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Humanitas Istituto Clinico Catanese
City
Misterbianco
State/Province
Catania
ZIP/Postal Code
95045
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
City
Bologna
State/Province
Emilia-romagna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuor
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCCS San Gerardo dei Tintori
City
Monza
State/Province
Lombardia
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria delle Marche
City
Ancona
State/Province
Marche
ZIP/Postal Code
60126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Generale Provinciale Macerata
City
Macerata
ZIP/Postal Code
62100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Europeo di Oncologia IRCCS
City
Milano
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Oncologico Veneto IRCCS
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Aichi Cancer Center Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagoya University Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagoya City University Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Individual Site Status
Recruiting
Facility Name
Chiba cancer center
City
Chiba-shi
State/Province
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cancer Center Hospital East
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Hokkaido Cancer Center
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kanagawa cancer center
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
2418515
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka University Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Individual Site Status
Recruiting
Facility Name
Saitama Prefectural Cancer Center
City
Ina-machi
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Individual Site Status
Recruiting
Facility Name
Juntendo University Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Metropolitan Komagome Hospital, Department of Breast Surgery
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Individual Site Status
Recruiting
Facility Name
Japanese Foundation for Cancer Research
City
Koto
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Center for Global Health and Medicine
City
Shinjuku City
State/Province
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Kyushu Cancer Center
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sagara Hospital
City
Kagoshima
ZIP/Postal Code
892-0833
Country
Japan
Individual Site Status
Recruiting
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
Juntendo University Hospital
City
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Individual Site Status
Recruiting
Facility Name
Gachon University Gil Medical Center
City
Namdong-gu
State/Province
Incheon-gwangyeoksi [incheon]
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Kyǒnggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Kyǒnggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Ajou University Hospital
City
Suwon
State/Province
Kyǒnggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Korea University Anam Hospital
City
Seoul
State/Province
Seoul-teukbyeolsi [seoul]
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Seoul-teukbyeolsi [seoul]
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
State/Province
Seoul-teukbyeolsi [seoul]
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
State/Province
Seoul-teukbyeolsi [seoul]
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Gangnam Severance Hospital, Yonsei University Health System
City
Seoul
State/Province
Seoul-teukbyeolsi [seoul]
ZIP/Postal Code
06273
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Seoul-teukbyeolsi [seoul]
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic Univ. of Korea Seoul St. Mary's Hospital
City
Seoul
State/Province
Seoul-teukbyeolsi [seoul]
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
State/Province
Seoul-teukbyeolsi [seoul]
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Akershus Universitetssykehus
City
Lorenskog
State/Province
Akershus
ZIP/Postal Code
1474
Country
Norway
Individual Site Status
Not yet recruiting
Facility Name
Drammen Sykehus, Vestre Viken HF
City
Drammen
State/Province
Buskerud
ZIP/Postal Code
3004
Country
Norway
Individual Site Status
Not yet recruiting
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.
City
Kraków
State/Province
Małopolskie
ZIP/Postal Code
30-348
Country
Poland
Individual Site Status
Recruiting
Facility Name
KLIMED Marek Klimkiewicz
City
Białystok
State/Province
Podlaskie
ZIP/Postal Code
15-704
Country
Poland
Individual Site Status
Recruiting
Facility Name
COPERNICUS PL, Wojewodzkie Centrum Onkologii
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-219
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
City
Lodz
State/Province
Łódzkie
ZIP/Postal Code
90-338
Country
Poland
Individual Site Status
Recruiting
Facility Name
Puerto Rico Medical Research Center
City
Hato Rey
ZIP/Postal Code
00917
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
Pan American Center for Oncology Trials- Hospital Oncologico
City
Rio Piedras
ZIP/Postal Code
00935
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
FDI Clinical Research
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
Onkologicky ustav sv. Alzbety, s.r.o.
City
Bratislava
ZIP/Postal Code
812 50
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Narodny onkologicky ustav
City
Bratislava
ZIP/Postal Code
833 10
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Vychodoslovensky onkologicky ustav, a.s.
City
Kosice
ZIP/Postal Code
04191
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Nemocnica s poliklinikou Stefana Kukuru Michalovce, a.s.
City
Michalovce
ZIP/Postal Code
07101
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Nemocnica na okraji mesta n o
City
Partizanske
ZIP/Postal Code
95801
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Fakultna nemocnica s poliklinikou J.A. Reimana Presov
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Fakultna nemocnica Trnava
City
Trnava
ZIP/Postal Code
917 17
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Iatros International
City
Bloemfontein
State/Province
FREE State
ZIP/Postal Code
9301
Country
South Africa
Individual Site Status
Not yet recruiting
Facility Name
Wits Clinical Research
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2193
Country
South Africa
Individual Site Status
Not yet recruiting
Facility Name
Medical Oncology Centre of Rosebank
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2196
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Cancercare Rondebosch Oncology
City
Cape Town
State/Province
Western CAPE
ZIP/Postal Code
7700
Country
South Africa
Individual Site Status
Not yet recruiting
Facility Name
CHUAC-Hospital Teresa Herrera
City
A Coruña
State/Province
A Coruña [LA Coruña]
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario de Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Individual Site Status
Recruiting
Facility Name
Institut Català d'Oncologia (ICO) - Badalona
City
Badalona
State/Province
Barcelona [barcelona]
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Parc de Salut Mar - Hospital del Mar
City
Barcelona
State/Province
Barcelona [barcelona]
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Institut Català d'Oncologia - L'Hospitalet
City
L'Hospitalet de Llobregat
State/Province
Catalunya [cataluña]
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Donostia
City
San Sebastian
State/Province
Gipuzkoa
ZIP/Postal Code
20014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Arnau de Vilanova de Lleida
City
Lleida
State/Province
Lleida [lérida]
ZIP/Postal Code
25198
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
State/Province
Madrid, Comunidad DE
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen de la Victoria
City
Malaga
State/Province
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Osi Bilbao-Basurto
City
Bilbao
State/Province
PAÍS Vasco
ZIP/Postal Code
48013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen Nieves
City
Granada
ZIP/Postal Code
18012
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Unviersitario Virgen Nieves
City
Granada
ZIP/Postal Code
18012
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario HM Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Althaia, Xarxa Assistencial Universitària de Manresa
City
Manresa
ZIP/Postal Code
8423
Country
Spain
Individual Site Status
Recruiting
Facility Name
Sundsvalls Sjukhus
City
Sundsvall
ZIP/Postal Code
856 43
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Name
Tumor Zentrum Aarau
City
Aarau
State/Province
Aargau
ZIP/Postal Code
5000
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Kantonsspital Graubünden
City
Chur
State/Province
Grisons
ZIP/Postal Code
7000
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Name
Kantonsspital Frauenfeld - Spital Thurgau AG
City
Frauenfeld
State/Province
Thurgau
ZIP/Postal Code
8500
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Kantonsspital Münsterlingen - Spital Thurgau AG
City
Münsterlingen
State/Province
Thurgau
ZIP/Postal Code
CH8596
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Ospedale Regionale Bellinzona e Valli
City
Bellinzona
State/Province
Ticino
ZIP/Postal Code
6500
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Kantonsspital Winterthur
City
Winterthur
ZIP/Postal Code
8401
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Changhua Christian Hospital
City
Changhua County
State/Province
Changhua
ZIP/Postal Code
50006
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chang Gung Memorial Hospital at Kaohsiung
City
Kaohsiung Niao Sung Dist
State/Province
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chi Mei Medical Center
City
Tainan City
State/Province
Tainan
ZIP/Postal Code
71004
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chi Mei Hospital - Liouying Branch
City
Tainan City
State/Province
Tainan
ZIP/Postal Code
73657
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Mackay Memorial Hospital
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Koo Foundation Sun Yat-Sen Cancer Center
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Municipal Wan Fang Hospital
City
Taipei
ZIP/Postal Code
116
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chang Gung Medical Foundation-Linkou Branch
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Memorial Ankara Hastanesi
City
Ankara
ZIP/Postal Code
06520
Country
Turkey
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C4891001
Description
To obtain contact information for a study center near you, click here.
URL
https://www.pfizerclinicaltrials.com/nct05654623-advanced-breast-cancer-trial
Description
VERITAC-2 Study Pfizer Clinical Trials

Learn more about this trial

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

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