A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease... | NCT02340221 | Trialant

A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease... | NCT02340221 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Postmenopausal women with histologically or cytologically confirmed locally advanced or metastatic estrogen receptor (ER) positive breast cancer

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Participants for whom endocrine therapy (example [e.g.], fulvestrant) is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study

Radiologic/objective evidence of recurrence or progression to the most recent systemic therapy for breast cancer

Radiologic/objective evidence of breast cancer recurrence or progression while on or within 12 months of the end of adjuvant treatment with an aromatase inhibitor (AI), or progression while on or within 1 month of the end of prior AI treatment for locally advanced or metastatic breast cancer

Measurable disease via Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) or non-measurable, evaluable disease with at least one evaluable bone lesion via RECIST v1.1

Consent to provide a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block (preferred) or a minimum of 20 (25 preferred) freshly cut unstained tumor slides from the most recently collected, available tumor tissue for oncogene that encodes for phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutation testing

A valid cobas PIK3CA mutation result by central testing is required

Adequate hematologic and end-organ function within 28 days prior to treatment initiation

Exclusion Criteria:

Human epidermal growth factor receptor 2 (HER2)-positive disease by local laboratory testing (immunohistochemistry 3 positive [IHC 3+] staining or in situ hybridization positive)

Prior treatment with fulvestrant

Prior treatment with a phosphatidylinositol 3-kinase (PI3K) inhibitor, mammalian target of rapamycin (mTOR) inhibitor (e.g. everolimus), or protein kinase B (AKT) inhibitor

Prior anti-cancer therapy within 2 weeks prior to Day 1 of Cycle 1

Prior radiation therapy within 2 weeks prior to Day 1 of Cycle 1

All acute treatment-related toxicity must have resolved to Grade less than or equal to (</=) 1 or be deemed stable by the Investigator

Prior treatment with greater than (>) 1 cytotoxic chemotherapy regimen for metastatic breast cancer

Concurrent hormone replacement therapy

Known untreated or active central nervous system (CNS) metastases

Type 1 or Type 2 diabetes mellitus requiring anti-hyperglycemic medications

History of inflammatory bowel disease or active bowel inflammation

Clinically significant cardiac or pulmonary dysfunction

Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with human immunodeficiency virus (HIV), hepatitis B or C virus

Arizona Oncology

Tucson, Arizona 85704, United States

Arizona Oncology Associates, P.C.

Tucson, Arizona 85710, United States

Georgia Cancer Specialists - Northside

Atlanta, Georgia 30341, United States

Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

Marietta, Georgia 30060, United States

Ingalls Hospital

Harvey, Illinois 60426, United States

Maryland Oncology Hematology

Rochville, Maryland 20850, United States

Dana Farber Can Ins

Boston, Massachusetts 02215, United States

Mercy Hospitals East Communities d/b/a Mercy Hospital St. Louis

St Louis, Missouri 63141, United States

MSKCC at Basking Ridge

Basking Ridge, New Jersey 07920, United States

John Theurer Cancer Ctr at Hackensack Univ Medical Ctr

Hackensack, New Jersey 07601, United States

Memorial Sloan-Kettering; Cancer Center

Commack, New York 11725, United States

Memorial Sloan Kettering Cancer Center; Memorial Sloan Kettering; at Westchester

Harrison, New York 10604, United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065, United States

Memorial Sloan Kettering Nassau

Uniondale, New York 11553, United States

Oregon Health & Science University; Knight Cancer Institute, Community Hematology Oncology

Beaverton, Oregon 97006, United States

Pinnacle Health

Harrisburg, Pennsylvania 17110, United States

Liverpool Hospital; Cancer Therapy Centre

Liverpool, New South Wales 2170, Australia

Macquarie University Hospital

Macquarie Park, New South Wales 2109, Australia

Newcastle Mater Misericordiae Hospital; Oncology

Waratah, New South Wales 2298, Australia

Mater Hospital; Oncology

Brisbane, Queensland 4101, Australia

Austin Hospital; Medical Oncology

Heidelberg, Victoria 3084, Australia

Sunshine Hospital; Oncology Research

St Albans, Victoria, Australia

St John of God Murdoch Hospital; Oncology West

Murdoch, Western Australia 6150, Australia

Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I

Graz, 8036, Austria

Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie

Innsbruck, 6020, Austria

Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1

Linz, 4010, Austria

Medizinische Universität Wien; Univ.Klinik für Innere Medizin I

Vienna, 1090, Austria

University Clinical Center of the Republic of Srpska

Banja Luka, 78000, Bosnia and Herzegovina

Clinic of Oncology, University Clinical Center Sarajevo

Sarajevo, 7100, Bosnia and Herzegovina

Complex Oncological Center - Plovdiv, EOOD

Plovdiv, 4004, Bulgaria

MHAT Nadezhda

Sofia, 1330, Bulgaria

SHATO - Sofia

Sofia, 1756, Bulgaria

SHATOD Dr. Marko Antonov Markov-Varna, EOOD

Varna, 9010, Bulgaria

Cross Cancer Institute

Edmonton, Alberta T6G 1Z2, Canada

British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

Vancouver, British Columbia V5Z 4E6, Canada

Grand River Hospital

Kitchener, Ontario N2G 1G3, Canada

The Ottawa Hospital Cancer Centre; Oncology

Ottawa, Ontario K1H 8L6, Canada

Sunnybrook Health Science Centre

Toronto, Ontario M4N 3M5, Canada

McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

Montreal, Quebec H3T 1E2, Canada

Hospital Du Saint-Sacrement

Québec, Quebec G1S 4L8, Canada

the First Hospital of Jilin University

Changchun, 130021, China

Jilin Cancer Hospital

Changchun, 132013, China

Jiangsu Cancer Hospital

Nanjing, 211100, China

Fudan University Shanghai Cancer Center

Shanghai, 200120, China

Zhejiang Cancer Hospital

Zhejiang, 310022, China

Clinica del Country

Bogotá, 11001, Colombia

Oncomedica S.A.

Montería, 230002, Colombia

University Hospital; Oncology and Radiotherapy

Hradec Králové, 500 05, Czechia

Fakultni nemocnice Olomouc; Onkologicka klinika

Olomouc, 779 00, Czechia

Vseobecna fakultni nemocnice v Praze

Prague, 128 08, Czechia

KYS Sadesairaala; Syopatautien poliklinikka

Kuopio, 70210, Finland

Turku Uni Central Hospital; Oncology Clinics

Turku, 20520, Finland

Centre Jean Perrin; Hopital De Semaine

Clermont-Ferrand, 63011, France

Centre Georges François Leclerc; Service Pharmacie, Bp 77980

Dijon, 21000, France

Hopital Prive Drome Ardeche; Chir 2A 2B

Guilherand-Granges, 07500, France

CHD Vendée

La Roche-sur-Yon, 85025, France

Hopital Dupuytren; Oncologie Medicale

Limoges, 87042, France

Institut régional du Cancer Montpellier

Montpellier, 34298, France

Institut Curie; Oncologie Medicale

Paris, 75231, France

Ch Lyon Sud; Onco Secteur Jules Courmont

Pierre-Bénite, 69495, France

Pole de Cancerologie Prive Strasbourgeois

Strasbourg, 67000, France

Centre Alexis Vautrin; Oncologie Medicale

Vandœuvre-lès-Nancy, 54519, France

Hochwaldkrankenhaus; Abt.Gynäkologie Geburtshilfe u.Senologie

Bad Nauheim, 61231, Germany

Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)

Berlin, 10367, Germany

Onkologische Schwerpunktpraxis Kurfürstendamm

Berlin, 10707, Germany

Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

Essen, 45122, Germany

Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem

Hamburg, 20357, Germany

Klinikum der Universität München; Frauenklinik - Onkologie II

München, 80337, Germany

Klinikum Mutterhaus der Borromäerinnen, Innere Medizin I

Trier, 54290, Germany

Alexandras General Hospital of Athens; Oncology Department

Athens, 115 28, Greece

IASO General Hospital of Athens

Athens, 155 62, Greece

Univ General Hosp Heraklion; Medical Oncology

Heraklion, 711 10, Greece

University Hospital of Patras Medical Oncology

Pátrai, 265 04, Greece

Euromedical General Clinic of Thessaloniki; Oncology Department

Thessaloniki, 546450, Greece

Papageorgiou General Hospital; Medical Oncology

Thessaloniki, 564 29, Greece

Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica

Naples, Campania 80131, Italy

ARCISPEDALE S. MARIA NUOVA - REGGIO EMILIA; Struttura Semplice Coordinamento Breast Unit Integrata

Reggio Emilia, Emilia-Romagna 42100, Italy

A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia

Udine, Friuli Venezia Giulia 33100, Italy

IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

Genoa, Liguria 16132, Italy

Istituto Europeo Di Oncologia

Milan, Lombardy 20141, Italy

Centro Catanese Di Oncologia; Oncologia Medica

Catania, Sicily 95126, Italy

Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia

Florence, Tuscany 50134, Italy

Azienda USL 9 Grosseto; Dipartimento Politiche del Farmaco

Grosseto, Tuscany 58100, Italy

Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia

Pontedera, Tuscany 56025, Italy

AZ. Usll12 Veneziana-Ospedale Dell'angelo;Oncologia Medica

Mestre, Veneto 30174, Italy

Iem-Fucam

D.F., 04980, Mexico

Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios

Distrito Federal, 14000, Mexico

Consultorio de Medicina Especializada; Dentro de Condominio San Francisco

Mexico City, 03100, Mexico

Hospital San Jose Del Tec. de Monterrey; Oncology

Monterrey, 64020, Mexico

Oaxaca Site Management Organization

Oaxaca City, 68000, Mexico

Medisch Centrum Alkmaar

Alkmaar, 1815 JD, Netherlands

Ziekenhuis Rijnstate

Arnhem, 6815 AD, Netherlands

Instituto Nacional de Enfermedades Neoplasicas

Lima, Lima 34, Peru

Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

Lima, Lima 41, Peru

Oncocenter Peru S.A.C.; Oncosalud

Lima, Lima 41, Peru

Instituto Regional de Enfermedades Neoplasicas - IREN Norte

Trujillo, 13014, Peru

Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej

Bialystok, 15-027, Poland

Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii

Bydgoszcz, 85-796, Poland

Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

Gdansk, 80-214, Poland

Przychodnia Lekarska KOMED, Roman Karaszewski

Konin, 62-500, Poland

Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

Krakow, 30-688, Poland

Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii

Lodz, 93-513, Poland

Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii

Lublin, 20-090, Poland

Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych

Szczecin, 71-730, Poland

Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii

Warsaw, 02-781, Poland

Wojewodzki Szpital Specjalistyczny; Osrodek Badawczo-Rozwojowy, Oddzial Chemioterapii

Wroclaw, 51-124, Poland

Hospital Garcia de Orta; Servico de Oncologia Medica

Almada, 2801-951, Portugal

IPO de Lisboa; Servico de Oncologia Medica

Lisbon, 1099-023, Portugal

Hospital da Luz; Departamento de Oncologia Medica

Lisbon, 1500-650, Portugal

Hospital de Santa Maria; Servico de Oncologia Medica

Lisbon, 1649-035, Portugal

IPO do Porto; Servico de Oncologia Medica

Porto, 4200-072, Portugal

Institut of Oncology Al. Trestioreanu Bucharest; Oncology Department

Bucharest, 022328, Romania

Prof. Dr. I. Chiricuta Institute of Oncology

Cluj-Napoca, 400015, Romania

Oncology Center Sf. Nectarie

Craiova, 200347, Romania

Euroclinic Center of Oncology SRL

Iași, 700106, Romania

Moscow City Oncology Hospital #62

Moscovskaya Oblast, Moscow Oblast 143423, Russia

Regional Clinical Oncology Dispensary; Surgery Dept, Thoracic

Arkhangelsk, 163045, Russia

Ivanovo Regional Oncology Dispensary

Ivanovo, 153040, Russia

Clinical Oncology Dispensary of Ministry of Health of Tatarstan

Kazan', 420029, Russia

State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis

Orenburg, 460021, Russia

S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

Saint Petersburg, 197758, Russia

Institute for Onc/Rad Serbia

Belgrade, 11000, Serbia

Inje university Haeundae Paik Hospital

Busan, 48108, South Korea

Chungbuk National University Hospital

Cheongju-si, 28644, South Korea

National Cancer Center

Goyang-si, 10408, 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

Samsung Medical Center

Seoul, 06351, South Korea

Ulsan University Hosiptal

Ulsan, 44033, South Korea

Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

Santiago de Compostela, LA Coruña 15706, Spain

Hospital Universitario Puerta de Hierro; Servicio de Oncologia

Majadahonda, Madrid 28222, Spain

Hospital Universitario de Canarias;servicio de Oncologia

San Cristóbal de La Laguna, Tenerife 38320, Spain

Hospital de Cruces; Servicio de Oncologia

Bilbao, Vizcaya 48903, Spain

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Hospital Clínic i Provincial; Servicio de Hematología y Oncología

Barcelona, 08036, Spain

Centro Oncologico MD Anderson Internacional; Servicio de Oncologia

Madrid, 28033, Spain

Hospital Ramon y Cajal; Servicio de Oncologia

Madrid, 28034, Spain

HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

Madrid, 28050, Spain

Fundación IVO

Valencia, 46980, Spain

Hospital Universitario Miguel Servet; Servicio Oncologia

Zaragoza, 50009, Spain

Uni Hospital Linkoeping; Dept. of Oncology

Linköping, 58185, Sweden

Sodersjukhuset; Onkologkliniken

Stockholm, 118 83, Sweden

Akademiska sjukhuset, Onkologkliniken

Uppsala, 751 85, Sweden

VETERANS GENERAL HOSPITAL; Department of General Surgery

Taipei, 00112, Taiwan

National Taiwan Uni Hospital; General Surgery

Taipei, 100, Taiwan

Mackay Memorial Hospital; Dept of Surgery

Taipei, 104, Taiwan

Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

Taipei, 11259, Taiwan

Department of Surgery, King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

Bangkok, 10400, Thailand

Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial

Chiang Mai, 50200, Thailand

Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology

Adana, 01230, Turkey (Türkiye)

Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

Edirne, 22770, Turkey (Türkiye)

Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

Istanbul, 34300, Turkey (Türkiye)

Ege Uni Medical Faculty; Oncology Dept

Izmir, 35100, Turkey (Türkiye)

Hacettepe Uni Medical Faculty Hospital; Oncology Dept

Sihhiye/Ankara, 06230, Turkey (Türkiye)