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NCT05646862PHASE3Recruiting

A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy

Hoffmann-La Roche

Start Date

6/7/2023

Completion Date

3/30/2029

Summary

This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) -negative, PIK3CA-mutated, locally advanced (LA) or metastatic breast cancer (mBC), who progressed during or after cyclin dependent kinase 4/6i (CDK4/6i)-based therapy. Enrollment for the main study is now complete.

Detailed Description

The drug-drug interaction (DDI) substudy will evaluate the impact of repeat doses of inavolisib (coadministered with fulvestrant) on single-dose pharmacokinetics of sensitive CYP450 enzyme substrates (midazolam, omeprazole and bupropion) in participants with hormone receptor (HR)-positive, HER2-negative, PIK3CA-mutated, locally advanced (LA) or metastatic breast cancer (mBC), who progressed during or after CDK4/6 inhibitor (CDK4/6i) in combination with endocrine therapy (ET). Enrollment for the substudy is now open to recruitment.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria for Main Study and Sub-study: * If pre/perimenopausal women and men treatment with luteinizing hormone-releasing hormone (LHRH) agonist therapy beginning at least 2 weeks prior to Day 1 of Cycle 1 * Histologically or cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to surgical or radiation therapy with curative intent * Documented HR +/ HER2- tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines * Confirmation of biomarker eligibility: detection of specified mutation(s) of PIK3CA via specified test * Disease progression after or during treatment with a combination of CDK4/6i and endocrine therapy: \<= 2 prior lines of systemic therapy in mBC setting; CDK4/6i based therapy does not need to be the last one received prior study entry; one line of chemotherapy in mBC setting allowed * Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) * Participants for whom endocrine-based therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 * Life expectancy of \> 6 months * Adequate hematologic and organ function prior to initiation of study treatment Exclusion Criteria for both Main Study and Sub-study: * Metaplastic breast cancer * Prior treatment in locally advanced or metastatic setting with any PI3K, AKT, or mTOR inhibitor or any agent whose mechanism of action is to inhibit the PI3K/-AKT/-mTOR pathway * Participant who relapsed with documented evidence of progression \> 12 months from completion of adjuvant CDK4/6i based therapy with no treatment for metastatic disease * Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes * Inability or unwillingness to swallow pills * Malabsorption syndrome or other condition that would interfere with enteral absorption * Any history of leptomeningeal disease or carcinomatous meningitis * Known and untreated, or active central nervous system (CNS) metastases. Participants with a history of treated CNS metastases are eligible if they meet specific certain criteria * Any concurrent ocular or intraocular condition that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition * Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye * Requirement for daily supplemental oxygen * Symptomatic active lung disease, including pneumonitis * History of or active inflammatory bowel disease * Any active bowel inflammation * Clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis * Participants with known human immunodeficiency virus infection that meet specific criteria * History of other malignancy within 5 years prior to screening, except for cancers with very low risk of recurrence * Chronic therapy of \>= 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressants for a chronic disease * Active ongoing osteonecrosis of the jaw Exclusion Criteria for Main Study Only: * Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or at least 60 days after the final dose of study treatment * Known active, systemic infection at study enrollment, or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 7 days prior to Day 1 of Cycle 1 * Investigational drug(s) within 4 weeks before randomization or within 5 half-lives of the investigational drug(s), whichever is longer * Allergy or hypersensitivity to components or excipients of the inavolisib, fulvestrant, or alpelisib formulations * History of severe cutaneous reactions like Stevens-Johnson Syndrome, Erythema Multiforme, Toxic Epidermal Necrolysis, or Drug Reaction with Eosinphilia and Systemic Symptoms Exclusion Criteria for Sub-study Only: * Pregnant, lactating, or breastfeeding, or intending to become pregnant during the substudy or within 2 weeks after the final dose of inavolisib and within 2 years after the final dose of fulvestrant, whichever is longer * Known active, systemic infection at study enrollment, or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 7 days prior to Day -4 of Cycle 1 * Investigational drug(s) within 4 weeks prior to Day -4 or within 5 half-lives of the investigational drug(s), whichever is longer * Allergy or hypersensitivity to components or excipients of the inavolisib, fulvestrant formulations * Treatment with mild, moderate, or strong inducers of CYP2B6, CYP3A4, and/or CYP2C19 (including St. John's Wort) within 14 days or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study treatment on Day -4 until after the final PK sample has been collected on Day 15 of Cycle 1 * Treatment with mild, moderate, or strong inhibitors of CYP2B6, CYP3A4, and/or CYP2C19 (including grapefruit juice or supplements) within 14 days or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study treatment on Day -4 until after the final PK sample has been collected on Day 15 of Cycle 1

Interventions

DRUG

Inavolisib

DRUG

Fulvestrant

DRUG

Alpelisib

DRUG

Bupropion

DRUG

Omeprazole

DRUG

Midazolam

Interested in This Trial?

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Conditions

Breast Cancer

Locations

Marin Cancer Care Inc

Greenbrae, California 94904

United States

Cancer Blood and Specialty Clinic

Los Alamitos, California 90720

United States

Los Angeles Cancer Network

Los Angeles, California 90017-4803

United States

University of California, Irvine Medical Center

Orange, California 92868

United States

UC Davis Comprehensive Cancer Center

Sacramento, California 95817

United States

Rocky Mountain Cancer Centers

Denver, Colorado 80220

United States

Banner MD Anderson Cancer Center

Greeley, Colorado 85234

United States

Eastern CT Hematology and Oncology Associates

Norwich, Connecticut 06360-2740

United States

Cancer Care Centers of Brevard

Palm Bay, Florida 32901

United States

Cleveland Clinic Florida

Weston, Florida 33331

United States

Grady Health System

Atlanta, Georgia 30303

United States

Midtown West Medical

Atlanta, Georgia 30318

United States

Emory University Hospital

Atlanta, Georgia 30322

United States

Winship Cancer Institute at Emory Saint Joseph's Hospital

Atlanta, Georgia 30342

United States

University of Louisville Hospital

Louisville, Kentucky 40202

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Karmanos Cancer Institute.

Detroit, Michigan 48201

United States

Cancer & Hematology Centers of Western Michigan

Grand Rapids, Michigan 49503

United States

Minnesota Oncology Hematology

Saint Paul, Minnesota 55102

United States

MD Anderson Cancer Center at Cooper

Camden, New Jersey 08103

United States

Novant Health Presbyterain Medical Center

Charlotte, North Carolina 28204

United States

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina 27103

United States

Gabrail Cancer Center

Canton, Ohio 44718

United States

Asante Rogue Regional Medical Center

Medford, Oregon 97504-8332

United States

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania 19010-3121

United States

St. Lukes Hospital and Health Network

Easton, Pennsylvania 18045

United States

Paoli Memorial Hospital

Paoli, Pennsylvania 19301

United States

Abramson Cancer Center Chester County Hospital

West Chester, Pennsylvania 19380

United States

Lankenau Medical Center, Cancer Center

Wynnewood, Pennsylvania 19096

United States

Main Line Health System

Wynnewood, Pennsylvania 19096

United States

WellSpan Oncology Research

York, Pennsylvania 17403

United States

Texas Oncology West

Amarillo, Texas 79106

United States

Texas Oncology - Dallas Presbyterian Hospital

Dallas, Texas 75231

United States

Texas Tech University Health Sciences Center

El Paso, Texas 79905

United States

Texas Oncology (Flower Mound) - USOR

Flower Mound, Texas 75028

United States

The Center for Cancer and Blood Disorders - Fort Worth

Fort Worth, Texas 76104

United States

Lumi Research

Kingwood, Texas 77339

United States

Texas Oncology McKinney

McKinney, Texas 75071

United States

Kadlec Clinic Hematology and Oncology

Kennewick, Washington 99336-7774

United States

Centro de Investigaciones Médicas y Desarrollo LC S.R.L

Buenos Aires, C1113AAE

Argentina

Centro Oncologico Korben

Ciudad Autonoma Buenos Aires, C1426AGE

Argentina

Fundacion CORI para la Investigacion y Prevencion del Cancer

La Rioja, F5300COE

Argentina

Instituto de Oncología de Rosario

Rosario, S2000KZE

Argentina

Sanatorio Parque S.A.

Rosario, S2000QGB

Argentina

Hosp Provincial D. Centenarios

Rosario, S2002KDS

Argentina

CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

San Juan, J5400DIL

Argentina

Clinica Viedma S.A.

Viedma, R8500ACE

Argentina

Campbelltown Hospital

Campbelltown, New South Wales 2560

Australia

Coffs Harbour Health Campus

Coffs Harbour, New South Wales 2450

Australia

Concord Repatriation General Hospital

Concord, New South Wales 2139

Australia

Kinghorn Cancer Centre

Darlinghurst, New South Wales 2010

Australia

Gosford Hospital

Gosford, New South Wales 2250

Australia

Icon Cancer Care Wesley

Auchenflower, Queensland 4066

Australia

University of the Sunshine Coast

Sippy Downs, Queensland 4556

Australia

Bendigo Cancer Centre

Bendigo, Victoria 3550

Australia

Sir Charles Gairdner Hospital

Perth, Western Australia 6009

Australia

Cliniques Universitaires St-Luc

Brussels, 1200

Belgium

GHdC Site Les Viviers

Charleroi, 6000

Belgium

UZ Antwerpen

Edegem, 2650

Belgium

UZ Gent

Ghent, 9000

Belgium

UZ Leuven Gasthuisberg

Leuven, 3000

Belgium

Clinique Ste-Elisabeth

Namur, 5000

Belgium

Hospital da Bahia

Salvador, Estado de Bahia 41810-011

Brazil

Instituto D?Or de Pesquisa e Ensino ? Hospital DF STAR

Brasília, Federal District 70390-140

Brazil

NUPEC

Belo Horizonte, Minas Gerais 30210-090

Brazil

Hospital Santa Cruz / Centro de Oncologia D'Or

Curitiba, Paraná 80420-090

Brazil

Hospital do Cancer de Pernambuco - HCP

Recife, Pernambuco 50040-000

Brazil

Instituto D?Or de Pesquisa e Ensino ? Hospital Esperança Recife

Recife, Pernambuco

Brazil

Vencer Oncoclínica - Centro de Pesquisa do Piauí

Teresina, Piauí 64049-200

Brazil

Liga Norte Riograndense Contra O Câncer

Natal, Rio Grande do Norte 59040150

Brazil

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul 90050-170

Brazil

Hospital Sao Lucas - PUCRS

Porto Alegre, Rio Grande do Sul 90610-000

Brazil

Hospital de Base de Sao Jose do Rio Preto

São José do Rio Preto, São Paulo 15090-000

Brazil

Hospital Sírio-Libanês

São Paulo, São Paulo 01308-050

Brazil

Arthur J.E. Child Comprehensive Cancer Center-Calgary

Calgary, Alberta T2N 5G2

Canada

Cross Cancer Institute

Edmonton, Alberta T6G 1Z2

Canada

BC Cancer ? Vancouver

Vancouver, British Columbia V5Z 4E6

Canada

The Moncton Hospital

Moncton, New Brunswick E1C 6Z8

Canada

Juravinski Hospital

Hamilton, Ontario L8V 5C2

Canada

The Ottawa Hospital - General Campus

Ottawa, Ontario K1Y 4E9

Canada

CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont

Montreal, Quebec H1T 2M4

Canada

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec H2X 0C2

Canada

Jewish General Hospital

Montreal, Quebec H3T 1E2

Canada

Hôpital du Sacré-Coeur de Montreal

Montreal, Quebec H4J 1C5

Canada

The First Hospital of Jilin University

Changchun, 130021

China

Sichuan Provincial Cancer Hospital

Chengdu, 610041

China

The First Affiliated Hospital, Chongqing Medical University

Chongqing, 400016

China

Sun yat-sen University Cancer Center

Guangzhou, 510060

China

Guangdong Provincial People's Hospital

Guangzhou, 510180

China

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, 310009

China

Sir Run Run Shaw Hospital Zhejiang University

Hangzhou, 310016

China

Harbin Medical University Tumor Hospital

Harbin, 150049

China

Shandong Cancer Hospital

Jinan, 250117

China

The Second Affiliated Hospital to Nanchang University

Nanchang, 330006

China

Jiangsu Cancer Hospital

Nanjing, 211100

China

Tianjin Cancer Hospital

Tianjin, 300000

China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, 430023

China

Hubei Cancer Hospital

Wuhan, 430079

China

First Affiliated Hospital of Medical College of Xi'an Jiaotong University

Xi'an, 710061

China

Zhejiang Cancer Hospital

Zhejiang, 310022

China

Institut Sainte Catherine

Avignon, 84082

France

Centre Hospitalier de La Cote Basque

Bayonne, 64109

France

Polyclinique Bordeaux Nord

Bordeaux, 33300

France

Centre Leon Berard

Lyon, 69008

France

ICM

Montpellier, 34298

France

Centre Eugene Marquis

Rennes, 35042

France

IUCT Oncopole

Toulouse, 31100

France

Uniklinik RWTH Aachen Klinik für Gynäkologie und Geburtsmedizin

Aachen, 52074

Germany

Onkologische Schwerpunktpraxis Bielefeld

Bielefeld, 33604

Germany

Universitätsklinikum Essen

Essen, 45122

Germany

Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

Freiburg im Breisgau, 79110

Germany

Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH

Georgsmarienhütte, 49124

Germany

Universitätsmedizin Göttingen Georg-August-Universität

Göttingen, 37075

Germany

Mammazentrum Hamburg am Krankenhaus Jerusalem

Hamburg, 20357

Germany

Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie

Hanover, 30625

Germany

Nationales Centrum für Tumorerkrankungen (NCT)

Heidelberg, 69120

Germany

Brustzentrum Rhein-Ruhr Servicegesellschaft mbH

Mönchengladbach, 41061

Germany

Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt

München, 80336

Germany

St. Vincenz-Krankenhaus GmbH Paderborn Frauen- und Kinderklinik St. Louise

Paderborn, 33098

Germany

MVZ für Hämatologie und Onkologie Ravensburg GmBH

Ravensburg, 88212

Germany

A.O. S. Anna e San Sebastiano

Caserta, Campania 81100

Italy

IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola

Meldola, Emilia-Romagna 47014

Italy

AUSL della Romagna

Ravenna, Emilia-Romagna 48121

Italy

Irccs Centro Di Riferimento Oncologico (CRO)

Aviano, Friuli Venezia Giulia 33081

Italy

Ospedale San Raffaele

Milan, Lombardy 20132

Italy

ASL AL - Azienda Sanitaria Locale AL

Alessandria, Piedmont 15121

Italy

AOU Città della Salute e della Scienza di Torino

Turin, Piedmont 10126

Italy

Humanitas Centro Catanese Di Oncologia

Misterbianco (CT), Sicily 95045

Italy

Ospedale Di Macerata

Province of Macerata, The Marches 62100

Italy

Ospedale Santa Chiara

Trento, Trentino-Alto Adige 38100

Italy

Ospedale S. Giuseppe

Empoli (FI), Tuscany 50053

Italy

Panamerican Clinical Research S.A de C.V.

Guadalajara, Jalisco 44670

Mexico

RENATI INNOVATION S.A.P.I. de C.V

Guadalajara, Jalisco 44680

Mexico

COI Centro Oncologico Internacional Santa Fe

Mexico City, Mexico CITY (federal District) 01330

Mexico

Health Pharma Professional Research

Mexico City, Mexico CITY (federal District) 03100

Mexico

OncoMed

Mexico City, Mexico CITY (federal District) 03100

Mexico

ARKE Estudios Clínicos S.A. de C.V.

Mexico City, Mexico CITY (federal District) 06700

Mexico

Instituto Nacional de Cancerologia

Distrito Federal, 14080

Mexico

CENEIT Oncologicos

Mexico City, 03100

Mexico

Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

Morelia, 58260

Mexico

New Zealand Clinical Research - Auckland

Auckland, 1010

New Zealand

Centrum Onkologii im. Prof. Franciszka ?ukaszczyka

Bydgoszcz, 85-796

Poland

Szpital Morski im.PCK

Gdynia, 81-519

Poland

Narodowy Instytut Onkologii Odzia? w Gliwicach

Gliwice, 44-102

Poland

Przychodnia Lekarska KOMED, Roman Karaszewski

Konin, 62-500

Poland

Szpital Wojewódzki im. Miko?aja Kopernika

Koszalin, 75-581

Poland

Szpital Uniwersytecki w Krakowie

Krakow, 31-501

Poland

MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie

Rzeszów, 35-021

Poland

Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie

Warsaw, 02-781

Poland

Dr. W.M. Szpak Incorporated trading as Rainbow Oncology

Durban, 4126

South Africa

Hopelands Cancer Centre

Hilton, 3245

South Africa

Medical Oncology Centre of Rosebank

Johannesburg, 2196

South Africa

Richards Bay Oncology Centre

KwaZulu Natal, 3900

South Africa

Mountain View Oncology

Paarl, 7646

South Africa

Kyungpook National University Chilgok Hospital

Daegu, 41404

South Korea

National Cancer Center

Goyang-si, 10408

South Korea

CHA Bundang Medical Center

Gyeonggi-do, 13496

South Korea

Catholic Univ. of Incheon St.Mary's Hospital

Incheon, 21431

South Korea

Inha University Hospital

Incheon, 22332

South Korea

Korea University Anam Hospital

Seoul, 02841

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Severance Hospital, Yonsei University Health System

Seoul, 03722

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Gangnam Severance Hospital

Seoul, 06273

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

Seoul St Mary's Hospital

Seoul, 06591

South Korea

ICO L'Hospitalet

L'Hospitalet de Llobregat, Barcelona 08908

Spain

Complejo Hospitalario Universitario de Santiago (CHUS)

Santiago de Compostela, LA Coruna 15706

Spain

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Tenerife 38320

Spain

Hospital Universitari Vall d'Hebron

Barcelona, 08035

Spain

Hospital San Pedro De Alcantara

Cáceres, 10003

Spain

Hospital General Universitario Gregorio Marañon

Madrid, 28007

Spain

Hospital Ramon y Cajal

Madrid, 28034

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Hospital Regional Universitario Carlos Haya

Málaga, 29011

Spain

Hospital Universitario Virgen de Arrixaca

Murcia, 30120

Spain

Hospital Universitario Virgen Macarena

Seville, 41009

Spain

China Medical University Hospital

Taichung, 404

Taiwan

National Cheng Kung University Hospital

Tainan, 70457

Taiwan

Taipei Veterans General Hospital

Taipei, 11217

Taiwan

Chang Gung Memorial Hosipital at Linkou

Taoyuan City, 333

Taiwan

Veterans General Hospital - Taichung

Xitun Dist., 40705

Taiwan

National Taiwan University Hospital

Zhongzheng Dist., 10048

Taiwan

Chulalongkorn Hospital

Bangkok, 10330

Thailand

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, 50200

Thailand

Chulabhorn Hospital

Lak Si, 10210

Thailand

Songklanagarind Hospital

Songkhla, 90110

Thailand

Gulhane Training and Applicaton Hospital

Ankara, 06010

Turkey (Türkiye)

Memorial Ankara Hastanesi

Ankara, 06520

Turkey (Türkiye)

Dicle University Faculty of Medicine

Diyarbakır, 21280

Turkey (Türkiye)

Trakya University Medical Faculty

Edirne, 22030

Turkey (Türkiye)

Medipol Mega Üniversite Hastanesi Göztepe

Istanbul, 34214

Turkey (Türkiye)

Marmara Uni Faculty of Medicine

Istanbul, 34890

Turkey (Türkiye)

Ege Uni Medical Faculty Hospital

Izmir, 35100

Turkey (Türkiye)

Izmir Ataturk Training and Research Hospital

Izmir, 35360

Turkey (Türkiye)

Goztepe Prof.Dr. Suleyman Yalcin City Hospital

Kadiköy, 34722

Turkey (Türkiye)

Medical Park Seyhan Hospital

Seyhan, 01140

Turkey (Türkiye)

Hacettepe Uni Medical Faculty Hospital

Sihhiye/Ankara, 06230

Turkey (Türkiye)

Basingstoke and North Hampshire Hospital

Basingstoke, RG24 9NA

United Kingdom

Blackpool Victoria Hospital

Blackpool, FY3 8NR

United Kingdom

Dumfries and Galloway Royal Infirmary

Dumfries, DG1 4AP

United Kingdom

Western General Hospital

Edinburgh, EH4 2XU

United Kingdom

Princess Alexandra Hospital

Harlow, CM20 1QX

United Kingdom

St John's Hospital

Livingston, EH54 6PP

United Kingdom

St Bartholomew's Hospital

London, EC1M 6BQ

United Kingdom

Maidstone & Tonbridge Wells Hospital

Maidstone, ME16 9QQ

United Kingdom

Mount Vernon & Watford Hospital Trust

Northwood, HA6 2RN

United Kingdom

Churchill Hospital

Oxford, OX3 7LE

United Kingdom

Royal Preston Hosptial

Preston, PR2 9HT

United Kingdom

Royal Hampshire County Hospital

Winchester, SO22 5DG

United Kingdom