Clinical trial NCT02340221: A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy
Official title: A Phase III, Double-Blind, Placebo-Controlled, Randomized Study of Taselisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Locally Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-01-16
Enrollment: 631
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, oncogene that encodes for phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutant, unresectable, locally advanced or metastatic breast cancer after recurrence or progression during or after an aromatase inhibitor (AI) therapy. There will be a 2:1 randomization to the taselisib arm versus the placebo arm. Enrollment will be enriched for participants with PIK3CA mutant tumors via central testing. The anticipated duration of the study is approximately 3.5 years.


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

Primary outcomes:
measure: Progression-Free Survival (PFS) as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) at Primary Analysis
timeFrame: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
measure: PFS as Assessed by Investigator Using RECIST v1.1 at Final Analysis
timeFrame: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)
Secondary outcomes:
measure: Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]), as Assessed Using RECIST v.1.1 at Primary Analysis
timeFrame: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
measure: Percentage of Participants With Objective Response (PR Plus CR), as Assessed Using RECIST v.1.1 at Final Analysis
timeFrame: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)
measure: Overall Survival (OS) at Primary Analysis
timeFrame: From randomization up to death from any cause (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
measure: OS at Final Analysis
timeFrame: From randomization up to death from any cause (up to approximately 6.2 years)
measure: Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1 at Primary Analysis
timeFrame: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
measure: Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1 at Final Analysis
timeFrame: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)
measure: Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1 at Primary Analysis
timeFrame: Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
measure: Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1 at Final Analysis
timeFrame: Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)
measure: PFS as Assessed by Blinded Independent Central Review (BICR) Using RECIST v1.1 at Primary Analysis
timeFrame: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
measure: PFS as Assessed by BICR Using RECIST v1.1 at Final Analysis
timeFrame: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)
measure: Percentage of Participants With Adverse Events at Primary Analysis
timeFrame: From randomization up to the 15 Oct 2017 data cutoff, approximately 2.5 years.
measure: Percentage of Participants With Adverse Events at Final Analysis
timeFrame: From randomization up to approximately 6.2 years
measure: Maximum Observed Plasma Concentration (Cmax) of Taselisib
timeFrame: 1 to 4 hours (hrs) post-dose on Cycle (C) 1, Day (D) 1; 0 to 3 hrs pre-dose and 2 to 6 hrs post dose on Cycle 2, Day 1 (each cycle=28 days)
measure: Minimum Observed Plasma Concentration (Cmin) of Taselisib
timeFrame: 1 to 4 hrs post-dose on Cycle 1, Day 1; 0 to 3 hrs pre-dose and 2 to 6 hrs post dose on Cycle 2, Day 1; 0 to 3 hrs pre-dose on Cycle 6, Day 1 (each cycle=28 days)
measure: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score
timeFrame: Baseline, C2D1 up to C7D1 (each cycle=28 days)
measure: Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score
timeFrame: Baseline, C2D1 up to C7D1 (each cycle=28 days)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Oncology
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates, P.C.
state: Arizona
city: Atlanta
country: United States
facility: Georgia Cancer Specialists - Northside
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
state: Georgia
city: Harvey
country: United States
facility: Ingalls Hospital
state: Illinois
city: Rochville
country: United States
facility: Maryland Oncology Hematology
state: Maryland
city: Boston
country: United States
facility: Dana Farber Can Ins
state: Massachusetts
city: Saint Louis
country: United States
facility: Mercy Hospitals East Communities d/b/a Mercy Hospital St. Louis
state: Missouri
city: Basking Ridge
country: United States
facility: MSKCC at Basking Ridge
state: New Jersey
city: Hackensack
country: United States
facility: John Theurer Cancer Ctr at Hackensack Univ Medical Ctr
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan-Kettering; Cancer Center
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Cancer Center; Memorial Sloan Kettering; at Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
city: Beaverton
country: United States
facility: Oregon Health & Science University; Knight Cancer Institute, Community Hematology Oncology
state: Oregon
city: Harrisburg
country: United States
facility: Pinnacle Health
state: Pennsylvania
city: Liverpool
country: Australia
facility: Liverpool Hospital; Cancer Therapy Centre
state: New South Wales
city: Macquarie Park
country: Australia
facility: Macquarie University Hospital
state: New South Wales
city: Waratah
country: Australia
facility: Newcastle Mater Misericordiae Hospital; Oncology
state: New South Wales
city: Brisbane
country: Australia
facility: Mater Hospital; Oncology
state: Queensland
city: Heidelberg
country: Australia
facility: Austin Hospital; Medical Oncology
state: Victoria
city: St Albans
country: Australia
facility: Sunshine Hospital; Oncology Research
state: Victoria
city: Murdoch
country: Australia
facility: St John of God Murdoch Hospital; Oncology West
state: Western Australia
city: Graz
country: Austria
facility: Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I
city: Innsbruck
country: Austria
facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie
city: Linz
country: Austria
facility: Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1
city: Wien
country: Austria
facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Clinical Center of the Republic of Srpska
city: Sarajevo
country: Bosnia and Herzegovina
facility: Clinic of Oncology, University Clinical Center Sarajevo
city: Plovdiv
country: Bulgaria
facility: Complex Oncological Center - Plovdiv, EOOD
city: Sofia
country: Bulgaria
facility: MHAT Nadezhda
city: Sofia
country: Bulgaria
facility: SHATO - Sofia
city: Varna
country: Bulgaria
facility: SHATOD Dr. Marko Antonov Markov-Varna, EOOD
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre
state: British Columbia
city: Kitchener
country: Canada
facility: Grand River Hospital
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre; Oncology
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Science Centre
state: Ontario
city: Montreal
country: Canada
facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
state: Quebec
city: Quebec City
country: Canada
facility: Hospital Du Saint-Sacrement
state: Quebec
city: Changchun
country: China
facility: the First Hospital of Jilin University
city: Changchun
country: China
facility: Jilin Cancer Hospital
city: Nanjing City
country: China
facility: Jiangsu Cancer Hospital
city: Shanghai City
country: China
facility: Fudan University Shanghai Cancer Center
city: Zhejiang
country: China
facility: Zhejiang Cancer Hospital
city: Bogota
country: Colombia
facility: Clinica del Country
city: Monteria
country: Colombia
facility: Oncomedica S.A.
city: Hradec Kralove
country: Czechia
facility: University Hospital; Oncology and Radiotherapy
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc; Onkologicka klinika
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Kuopio
country: Finland
facility: KYS Sadesairaala; Syopatautien poliklinikka
city: Turku
country: Finland
facility: Turku Uni Central Hospital; Oncology Clinics
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin; Hopital De Semaine
city: Dijon
country: France
facility: Centre Georges François Leclerc; Service Pharmacie, Bp 77980
city: Guilherand Granges
country: France
facility: Hopital Prive Drome Ardeche; Chir 2A 2B
city: La Roche Sur Yon
country: France
facility: CHD Vendée
city: Limoges
country: France
facility: Hopital Dupuytren; Oncologie Medicale
city: Montpellier
country: France
facility: Institut régional du Cancer Montpellier
city: Paris
country: France
facility: Institut Curie; Oncologie Medicale
city: Pierre Benite
country: France
facility: Ch Lyon Sud; Onco Secteur Jules Courmont
city: Strasbourg
country: France
facility: Pole de Cancerologie Prive Strasbourgeois
city: Vandoeuvre-les-nancy
country: France
facility: Centre Alexis Vautrin; Oncologie Medicale
city: Bad Nauheim
country: Germany
facility: Hochwaldkrankenhaus; Abt.Gynäkologie Geburtshilfe u.Senologie
city: Berlin
country: Germany
facility: Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)
city: Berlin
country: Germany
facility: Onkologische Schwerpunktpraxis Kurfürstendamm
city: Essen
country: Germany
facility: Universitätsklinikum Essen; Zentrum Für Frauenheilkunde
city: Hamburg
country: Germany
facility: Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
city: München
country: Germany
facility: Klinikum der Universität München; Frauenklinik - Onkologie II
city: Trier
country: Germany
facility: Klinikum Mutterhaus der Borromäerinnen, Innere Medizin I
city: Athens
country: Greece
facility: Alexandras General Hospital of Athens; Oncology Department
city: Athens
country: Greece
facility: IASO General Hospital of Athens
city: Heraklion
country: Greece
facility: Univ General Hosp Heraklion; Medical Oncology
city: Patras
country: Greece
facility: University Hospital of Patras Medical Oncology
city: Thessaloniki
country: Greece
facility: Euromedical General Clinic of Thessaloniki; Oncology Department
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital; Medical Oncology
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica
state: Campania
city: Reggio Emilia
country: Italy
facility: ARCISPEDALE S. MARIA NUOVA - REGGIO EMILIA; Struttura Semplice Coordinamento Breast Unit Integrata
state: Emilia-Romagna
city: Udine
country: Italy
facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia
state: Friuli-Venezia Giulia
city: Genova
country: Italy
facility: IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A
state: Liguria
city: Milano
country: Italy
facility: Istituto Europeo Di Oncologia
state: Lombardia
city: Catania
country: Italy
facility: Centro Catanese Di Oncologia; Oncologia Medica
state: Sicilia
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia
state: Toscana
city: Grosseto
country: Italy
facility: Azienda USL 9 Grosseto; Dipartimento Politiche del Farmaco
state: Toscana
city: Pontedera
country: Italy
facility: Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia
state: Toscana
city: Mestre
country: Italy
facility: AZ. Usll12 Veneziana-Ospedale Dell'angelo;Oncologia Medica
state: Veneto
city: Busan
country: Korea, Republic of
facility: Inje university Haeundae Paik Hospital
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hosiptal
city: D.f.
country: Mexico
facility: Iem-Fucam
city: Distrito Federal
country: Mexico
facility: Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios
city: Mexico City
country: Mexico
facility: Consultorio de Medicina Especializada; Dentro de Condominio San Francisco
city: Monterrey
country: Mexico
facility: Hospital San Jose Del Tec. de Monterrey; Oncology
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization
city: Alkmaar
country: Netherlands
facility: Medisch Centrum Alkmaar
city: Arnhem
country: Netherlands
facility: Ziekenhuis Rijnstate
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplasicas
city: Lima
country: Peru
facility: Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
city: Lima
country: Peru
facility: Oncocenter Peru S.A.C.; Oncosalud
city: Trujillo
country: Peru
facility: Instituto Regional de Enfermedades Neoplasicas - IREN Norte
city: Bialystok
country: Poland
facility: Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
city: Konin
country: Poland
facility: Przychodnia Lekarska KOMED, Roman Karaszewski
city: Kraków
country: Poland
facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
city: Lodz
country: Poland
facility: Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii
city: Lublin
country: Poland
facility: Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii
city: Szczecin
country: Poland
facility: Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych
city: Warszawa
country: Poland
facility: Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
city: Wroclaw
country: Poland
facility: Wojewodzki Szpital Specjalistyczny; Osrodek Badawczo-Rozwojowy, Oddzial Chemioterapii
city: Almada
country: Portugal
facility: Hospital Garcia de Orta; Servico de Oncologia Medica
city: Lisboa
country: Portugal
facility: IPO de Lisboa; Servico de Oncologia Medica
city: Lisboa
country: Portugal
facility: Hospital da Luz; Departamento de Oncologia Medica
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria; Servico de Oncologia Medica
city: Porto
country: Portugal
facility: IPO do Porto; Servico de Oncologia Medica
city: Bucuresti
country: Romania
facility: Institut of Oncology Al. Trestioreanu Bucharest; Oncology Department
city: Cluj Napoca
country: Romania
facility: Prof. Dr. I. Chiricuta Institute of Oncology
city: Craiova
country: Romania
facility: Oncology Center Sf. Nectarie
city: Iasi
country: Romania
facility: Euroclinic Center of Oncology SRL
city: Moscovskaya Oblast
country: Russian Federation
facility: Moscow City Oncology Hospital #62
state: Moskovskaja Oblast
city: Arkhangelsk
country: Russian Federation
facility: Regional Clinical Oncology Dispensary; Surgery Dept, Thoracic
city: Ivanovo
country: Russian Federation
facility: Ivanovo Regional Oncology Dispensary
city: Kazan
country: Russian Federation
facility: Clinical Oncology Dispensary of Ministry of Health of Tatarstan
city: Orenburg
country: Russian Federation
facility: State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis
city: Saint-Petersburg
country: Russian Federation
facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
city: Belgrade
country: Serbia
facility: Institute for Onc/Rad Serbia
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
state: LA Coruña
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia
state: Madrid
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias;servicio de Oncologia
state: Tenerife
city: Bilbao
country: Spain
facility: Hospital de Cruces; Servicio de Oncologia
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología
city: Madrid
country: Spain
facility: Centro Oncologico MD Anderson Internacional; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal; Servicio de Oncologia
city: Madrid
country: Spain
facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
city: Valencia
country: Spain
facility: Fundación IVO
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet; Servicio Oncologia
city: Linköping
country: Sweden
facility: Uni Hospital Linkoeping; Dept. of Oncology
city: Stockholm
country: Sweden
facility: Sodersjukhuset; Onkologkliniken
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset, Onkologkliniken
city: Taipei City
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
city: Taipei
country: Taiwan
facility: VETERANS GENERAL HOSPITAL; Department of General Surgery
city: Taipei
country: Taiwan
facility: National Taiwan Uni Hospital; General Surgery
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital; Dept of Surgery
city: Bangkok
country: Thailand
facility: Department of Surgery, King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial
city: Adana
country: Turkey
facility: Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
city: Edirne
country: Turkey
facility: Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
city: Istanbul
country: Turkey
facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
city: Izmir
country: Turkey
facility: Ege Uni Medical Faculty; Oncology Dept
city: Sihhiye/Ankara
country: Turkey
facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Dent S, Cortes J, Im YH, Dieras V, Harbeck N, Krop IE, Wilson TR, Cui N, Schimmoller F, Hsu JY, He J, De Laurentiis M, Sousa S, Drullinsky P, Jacot W. Phase III randomized study of taselisib or placebo with fulvestrant in estrogen receptor-positive, PIK3CA-mutant, HER2-negative, advanced breast cancer: the SANDPIPER trial. Ann Oncol. 2021 Feb;32(2):197-207. doi: 10.1016/j.annonc.2020.10.596. Epub 2020 Nov 10.