Clinical trial NCT03337724: A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer
Official title: A Double-Blind, Placebo-Controlled, Randomized Phase III Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Patients With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2017-11-09
Enrollment: 579
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy of ipatasertib + paclitaxel versus placebo + paclitaxel in participants with histologically confirmed, locally advanced or metastatic triple-negative breast cancer (TNBC) and in participants with locally advanced or metastatic hormone receptor positive (HR+)/ human epidermal growth factor receptor 2 negative (HER2-) breast adenocarcinoma who are not suitable for endocrine therapy.


Eligibility criteria: Inclusion Criteria:

* Women or men aged =\>18 years with histologically documented triple-negative breast cancer (TNBC) or HR+/HER2- adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to resection with curative intent
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Adequate hematologic and organ function within 14 days prior to treatment initiation
* Histologically documented TNBC or HR+/HER2- adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to resection with curative intent
* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Eligible for taxane monotherapy, as per local investigator assessment (e.g., absence of rapid clinical progression, life-threatening visceral metastases, or the need for rapid symptom and/or disease control which may require combination chemotherapy)
* HR+/HER2- breast cancer that is not considered appropriate for endocrine-based therapy and meets one of the following: patient has recurrent disease \<=5 years of being on adjuvant endocrine therapy or if patient with de novo metastatic disease have progressed within 6 months of being on first line endocrine therapy.
* Consent to submit a formalin-fixed, paraffin-embedded tumor (FFPE) tissue block or freshly cut unstained, serial tumor slides from the most recently collected tumor tissue for central molecular analysis
* Confirmation of biomarker eligibility using an appropriately validated molecular assay at a diagnostic laboratory, Clinically Laboratory Improvement Amendments (CLIA) or equivalently accredited i.e., valid results from either central testing or local testing of tumor tissue or blood demonstrating PIK3CA/AKT1/PTEN-altered status
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs
* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods and agreement to refrain from donating sperm

Exclusion Criteria:

* Treatment with approved or investigational cancer therapy within 14 days prior to treatment initiation
* Any previous chemotherapy for inoperable locally advanced or metastatic TNBC or HR+/HER2- adenocarcinoma of the breast (patients receiving neo/adjuvant chemotherapy eligible provided they have at least a 12 month disease-free interval)
* History of or known presence of brain or spinal cord metastases
* Malignancies other than breast cancer within 5 years prior to treatment initiation (except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer)
* Prior treatment with an Akt inhibitor (prior PI3K or mTOR inhibitors are allowed)
* History of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills
* Active infection requiring systemic anti-microbial treatment (including antibiotics, anti-fungals, and anti-viral agents)
* Known human immunodeficiency virus (HIV) infection
* Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis, current drug or alcohol abuse, or cirrhosis
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of treatment (or anticipated need during study)
* Pregnant or breastfeeding, or intending to become pregnant during the study
* Clinically significant cardiac dysfunction (including NYHA Class II/III/IV heart failure, left ventricular ejection fraction \[LVEF\] \<50%, active ventricular arrhythmia requiring medication, history of myocardial infarction within 6 months of treatment initiation, clinically significant electrocardiogram \[ECG\] abnormalities).
* Need for chronic corticosteroid therapy of \>=10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressants for a chronic disease
* Unresolved, clinically significant toxicity from prior therapy, except for alopecia and Grade 1 peripheral neuropathy
* Uncontrolled clinical symptoms including pleural effusion, pericardial effusion, or ascites, tumor-related pain, hypercalcemia (or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy)
* History of Type I or Type II diabetes mellitus requiring insulin
* Grade \>=2 uncontrolled or untreated hypercholesterolemia or hypertriglyceridemia
* History of or active inflammatory bowel disease or active bowel inflammation
* Clinically significant lung disease (including pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, active infection/ history of opportunistic infections)
* Treatment with strong CYP3A inhibitors or strong CYP3A inducers within 2 weeks or 5 drug-elimination half-lives, whichever is longer, prior to initiation of treatment
* Grade \>=2 peripheral neuropathy

Primary outcomes:
measure: Cohort A: Progression-Free Survival (PFS)
timeFrame: From randomization up to 27 months
measure: Cohort B: PFS
timeFrame: From randomization up to 24.4 months
measure: Cohort C: PFS
timeFrame: From enrollment up to 31 months
Secondary outcomes:
measure: Cohort A and B: Objective Response Rate (ORR)
timeFrame: From randomization up to 27 months for Cohort A and up to 24.4 months for Cohort B
measure: Cohort C: ORR
timeFrame: From enrollment up to 31 months
measure: Cohort A and B: Duration of Response (DOR)
timeFrame: From randomization up to 27 months for Cohort A and up to 24.4 months for Cohort B
measure: Cohort C: DOR
timeFrame: From enrollment up to 31 months
measure: Cohort A and B: Clinical Benefit Rate (CBR)
timeFrame: From randomization up to 27 months for Cohort A and up to 24.4 months for Cohort B
measure: Cohort C: CBR
timeFrame: From enrollment up to 31 months
measure: Overall Survival (OS)
timeFrame: From randomization/ enrollment (Cohort C) up to death from any cause, up to 45 months for Cohort A, up to 46 months for Cohort B and up to 31 months for Cohort C
measure: Cohort A and B: Change From Baseline in Global Health Status (GHS)/Health-Related Quality of Life (HRQoL) Score Measured by GHS/HRQoL Scale (Questions 29 and 30) of the EORTC QLQ-C30
timeFrame: Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 (cycle length=28 days)
measure: Cohort C: Change From Baseline in GHS/HRQoL Score Measured by GHS/HRQoL Scale (Questions 29 and 30) of the EORTC QLQ-C30
timeFrame: Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, and 44 (cycle length=28 days)
measure: Cohort B: Time to Deterioration (TTD) in Pain
timeFrame: Baseline up to 24.4 months
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 58.9 months for Cohort A, up to 59.9 months for Cohort B and up to 45.5 months for Cohort C
measure: Number of Participants With at Least One Adverse Events of Special Interest (AESI)
timeFrame: Up to 58.9 months for Cohort A, up to 59.9 months for Cohort B and up to 45.5 months for Cohort C
measure: Cohorts A and B:Plasma Concentration of Ipatasertib
timeFrame: Days 1 and 15 of Cycle 1: 1 to 3 hours post dose, and on Day 15 of Cycle 3: 2 to 4 hours post dose (cycle length= 28 days)
measure: Cohort C: Plasma Concentration of Ipatasertib
timeFrame: Days 1 and 15 of Cycle 1: 1 to 3 hours post dose, and on Day 15 of Cycle 3: 2 to 4 hours post dose (cycle length= 28 days)
measure: Cohorts A and B: Plasma Concentration of G-037720
timeFrame: Days 1 and 15 of Cycle 1: 1 to 3 hours post dose, and on Day 15 of Cycle 3: 2 to 4 hours post dose (cycle length= 28 days )
measure: Cohort C: Plasma Concentration of G-037720
timeFrame: Days 1 and 15 of Cycle 1: 1 to 3 hours post dose, and on Day 15 of Cycle 3: 2 to 4 hours post dose (cycle length= 28 days )
measure: Cohort C: 1-year Event-free PFS Rate
timeFrame: From enrollment until the occurrence of disease progression or death from any cause, whichever occurred earlier, up to 1 year
measure: Cohort C: 1-year Event-free OS Rate
timeFrame: From enrollment up to death from any cause, up to 1 year
measure: Cohort C: Serum Concentration of Atezolizumab
timeFrame: Day 1 of Cycle 1: 30 minutes post dose, predose on Day 15 of Cycle 1 and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (cycle length=28 days)
measure: Cohort C: Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
timeFrame: Up to 45.5 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Moores Cancer Center
state: California
city: Los Angeles
country: United States
facility: USC Norris Cancer Center
state: California
city: Newport Beach
country: United States
facility: USC Norris Cancer Center; USC Oncology Hematology Newport Beach
state: California
city: Oakland
country: United States
facility: Kaiser Permanente - Oakland
state: California
city: Roseville
country: United States
facility: Kaiser Permanente - Roseville
state: California
city: Sacramento
country: United States
facility: UC Davis; Comprehensive Cancer Center
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente Sacramento Medical Center
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente - San Francisco (2238 Geary)
state: California
city: San Francisco
country: United States
facility: UCSF Comprehensive Cancer Ctr
state: California
city: San Jose
country: United States
facility: K. Permanente - San Jose
state: California
city: San Leandro
country: United States
facility: Kaiser Permanente - San Leandro
state: California
city: Santa Clara
country: United States
facility: K. Permanente - Santa Clara
state: California
city: South San Francisco
country: United States
facility: Kaiser Permanente - South San Francisco
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente - Vallejo
state: California
city: Walnut Creek
country: United States
facility: K. Permanente - Walnut Creek
state: California
city: Hollywood
country: United States
facility: Memorial Regional Hospital
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Comprehensive Cancer Center
state: Florida
city: Orlando
country: United States
facility: UF Health Cancer Center at Orlando Health
state: Florida
city: Pembroke Pines
country: United States
facility: Memorial Hospital West
state: Florida
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: Harrison
country: United States
facility: Memorial Sloan Kettering Cancer Center at Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering
state: New York
city: Germantown
country: United States
facility: West Clinic
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center; Simmons Comprehensive Cancer Center, Simmons Pharmacy
state: Texas
city: Houston
country: United States
facility: Oncology Consultants PA
state: Texas
city: Buenos Aires
country: Argentina
facility: Fundación CENIT para la Investigación en Neurociencias
city: Rosario
country: Argentina
facility: Hosp Provincial D. Centenarios; Oncology Dept
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle; Medical Oncology
state: New South Wales
city: Wentworthville
country: Australia
facility: Westmead Hospital; Medical Oncology
state: New South Wales
city: South Brisbane
country: Australia
facility: Mater Hospital; Cancer Services
state: Queensland
city: Malvern
country: Australia
facility: Cabrini Medical Centre; Oncology
state: Victoria
city: Bull Creek
country: Australia
facility: Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit
state: Western Australia
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Charleroi
country: Belgium
facility: GHdC Site Notre Dame
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Salvador
country: Brazil
facility: Santa Casa de Misericordia de Salvador
state: BA
city: Goiania
country: Brazil
facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama
state: GO
city: Londrina
country: Brazil
facility: Hospital do Câncer de Londrina
state: PR
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Cancer - INCa; Oncologia
state: RJ
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas - PUCRS
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao
state: RS
city: Santo Andre
country: Brazil
facility: Faculdade de Medicina do ABC - FMABC
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Perola Byington
state: SP
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre
state: British Columbia
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Temuco
country: Chile
facility: Sociedad de Investigaciones Medicas Ltda (SIM)
city: San José
country: Costa Rica
facility: Clinica CIMCA
city: San José
country: Costa Rica
facility: ICIMED Instituto de Investigación en Ciencias Médicas
city: Brno
country: Czechia
facility: Masaryk?v onkologický ústav; Klinika komplexní onkologické pé?e
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc; Onkologicka klinika
city: Besançon Cedex
country: France
facility: CHU Besançon - Hôpital Jean Minjoz
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Dijon
country: France
facility: Centre Georges Francois Leclerc; Oncologie 3
city: Montpellier cedex 5
country: France
facility: ICM; Medecine B3
city: Nantes
country: France
facility: Centre Catherine De Sienne
city: Paris
country: France
facility: APHP - Hospital Saint Louis
city: Reims CEDEX
country: France
facility: Institut Jean Godinot; Oncologie Medicale
city: Berlin
country: Germany
facility: Onkologische Schwerpunktpraxis Kurfürstendamm
city: Freiburg
country: Germany
facility: Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf; Frauenklinik
city: Homburg/Saar
country: Germany
facility: Universitätsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe
city: Köln
country: Germany
facility: Praxis Dr.med. Katja Ziegler-Löhr
city: Langen
country: Germany
facility: Dres. Andreas Köhler und Roswitha Fuchs
city: Minden
country: Germany
facility: Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Frauenheilkunde und Geburtshilfe
city: Recklinghausen
country: Germany
facility: Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie
city: Rostock
country: Germany
facility: Universitätsfrauen- und Poliklinik am Klinikum Suedstadt
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg; Frauenklinik
city: Athens
country: Greece
facility: Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
city: Athens
country: Greece
facility: Agioi Anargyroi; 3Rd Dept. of Medical Oncology
city: Thessaloniki
country: Greece
facility: Euromedical General Clinic of Thessaloniki; Oncology Department
city: Budapest
country: Hungary
facility: Orszagos Onkologial Intezet; Onkologiai Osztaly X
city: Miskolc
country: Hungary
facility: Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
city: Szolnok
country: Hungary
facility: Hetenyi Geza County Hospital; Onkologiai Kozpont
city: Zalaegerszeg
country: Hungary
facility: Zala County Hospital ICU
city: New Delhi
country: India
facility: Indraprastha Apollo Hospitals
state: Delhi
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology
state: Delhi
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica
state: Campania
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
state: Emilia-Romagna
city: Aviano
country: Italy
facility: Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
state: Friuli-Venezia Giulia
city: Bagno a Ripoli
country: Italy
facility: Ospedale Santa Maria Annunziata; Oncologia
state: Toscana
city: Padova
country: Italy
facility: IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
state: Veneto
city: Aichi
country: Japan
facility: Aichi Cancer Center Hospital
city: Chiba
country: Japan
facility: National Cancer Center Hospital East
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center;Breast Oncology
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Hyogo
country: Japan
facility: Hyogo Medical University Hospital
city: Kanagawa
country: Japan
facility: St. Marianna University Hospital
city: Kanagawa
country: Japan
facility: Kanagawa Cancer Center
city: Kanagawa
country: Japan
facility: Tokai University Hospital
city: Kumamoto
country: Japan
facility: Kumamoto Shinto General Hospital
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka
country: Japan
facility: National Hospital Organization Osaka National Hospital
city: Osaka
country: Japan
facility: Kinki University Hospital, Faculty of Medicine; Surgery
city: Saitama
country: Japan
facility: Saitama Cancer Center, Breast Oncology
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
city: Tokyo
country: Japan
facility: St. Luke's International Hospital
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Tokyo
country: Japan
facility: Showa University Hospital; Breast Surgery
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang 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: Cdmx
country: Mexico
facility: Centro Medico Dalinde
state: Mexico CITY (federal District)
city: Monterrey
country: Mexico
facility: Centro Médico Zambrano Hellion
state: Nuevo LEON
city: Mérida
country: Mexico
facility: Merida | Investigacion Clinica
state: Yucatan
city: Mexico City
country: Mexico
facility: CENEIT Oncologicos; DENTRO DE CONDOMINIO SAN FRANCISCO
city: Bitola
country: North Macedonia
facility: Clinical Hospital; Oncology Department
city: Skopje
country: North Macedonia
facility: PHI University Clinic of Radiotherapy and Oncology; Breast malignancy
city: Skopje
country: North Macedonia
facility: PHI University Clinic of Radiotherapy and Oncology; Malignant diseases of thorax
city: Arequipa
country: Peru
facility: Centro Medico Monte Carmelo
city: Callao
country: Peru
facility: Hospital Daniel Alcides Carrion
city: Lima
country: Peru
facility: Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel
city: Lima
country: Peru
facility: Hospital Nacional Cayetano Heredia; Ocología; Servicio de Hematología Oncología Médica
city: Lima
country: Peru
facility: Oncosalud Sac; Oncología
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplasicas
city: San Isidro
country: Peru
facility: Clinica Ricardo Palma
city: Trujillo
country: Peru
facility: Instituto Regional de Enfermedades Neoplasicas - IREN Norte
city: ?ód?
country: Poland
facility: Instyt. Centrum Zdrowia Matki Polki; Klinika Chirurgii Onk. Chorób Piersi z Podod. Onko Klinicznej
city: Gliwice
country: Poland
facility: Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter.
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Nowotworow Piersi i Chirurgii Rekonstr
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Regional Clinical Oncology Dispensary
state: Arhangelsk
city: Moscovskaya Oblast
country: Russian Federation
facility: Moscow City Oncology Hospital #62
state: Moskovskaja Oblast
city: Moscow
country: Russian Federation
facility: Federal State Institution, Moscow Research Oncology Institute n.a. P.A. Hertzen; Oncourology
state: Moskovskaja Oblast
city: Moskva
country: Russian Federation
facility: Blokhin Cancer Research Center; Combined Treatment
state: Moskovskaja Oblast
city: Rostov-on-Don
country: Russian Federation
facility: FSI Rostov research oncological institute of MoH and SD of RF; PAD
state: Rostov
city: Saint-Petersburg
country: Russian Federation
facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
state: Sankt Petersburg
city: Kazan
country: Russian Federation
facility: Clinical Oncology Dispensary of Ministry of Health of Tatarstan
state: Tatarstan
city: Ivanovo
country: Russian Federation
facility: Ivanovo Regional Oncology Dispensary
city: Kaluga
country: Russian Federation
facility: SBIH Kaluga Region Clinical Oncology Dispensary
city: Singapore
country: Singapore
facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)
city: Singapore
country: Singapore
facility: National Cancer Centre; Medical Oncology
city: Ljubljana
country: Slovenia
facility: Institute of Oncology Ljubljana
city: Johannesburg
country: South Africa
facility: Medical Oncology Centre of Rosebank; Oncology
city: Castellon de La Plana
country: Spain
facility: Hospital Provincial de Castellon; Servicio de Oncologia
state: Castellon
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia; Servicio de Oncologia
state: Cordoba
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: Barcelona
country: Spain
facility: Hospital del Mar; Servicio de Oncologia
city: Barcelona
country: Spain
facility: Vall d?Hebron Institute of Oncology (VHIO), Barcelona
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona; Servicio de oncologia
city: Guipuzcoa
country: Spain
facility: Hospital de Donostia; 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: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia
city: Valencia
country: Spain
facility: Hospital Clinico Universitario; Oncologia
city: Liuying Township
country: Taiwan
facility: Chi Mei Medical Center Liou Ying Campus
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: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
city: Diyarbakir
country: Turkey
facility: Dicle Uni Medical Faculty; Internal Medicine
city: Istanbul
country: Turkey
facility: Medipol University Medical Faculty; Oncology Department
city: Istanbul
country: Turkey
facility: Prof. Dr. Cemil Tascioglu City Hospital; Med Onc
city: Izmir
country: Turkey
facility: Katip Celebi University Ataturk Training and Research Hospital; Oncology
city: Sakarya
country: Turkey
facility: Sakarya University Medical School; Medical Oncology
city: Dnipropetrovsk
country: Ukraine
facility: Chemotherapy SI Dnipropetrovsk MA of MOHU
city: Kiev
country: Ukraine
facility: Kyiv City Clinical Oncological Center, Day Hospital Department for Oncological patients
city: Kiev
country: Ukraine
facility: National Cancer Institute MOH of Ukraine
city: Lviv
country: Ukraine
facility: Lviv State Oncological Regional Treatment and Diagnostic Center
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Centre
city: Coventry
country: United Kingdom
facility: University Hospital coventry; Oncology Department
city: Glasgow
country: United Kingdom
facility: The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit
city: London
country: United Kingdom
facility: Royal Marsden Hospital - London
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Stoke-on-Trent
country: United Kingdom
facility: Royal Stoke University Hospital
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital; Dept of Medical Oncology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Turner N, Dent RA, O'Shaughnessy J, Kim SB, Isakoff SJ, Barrios C, Saji S, Bondarenko I, Nowecki Z, Lian Q, Reilly SJ, Hinton H, Wongchenko MJ, Kovic B, Mani A, Oliveira M. Ipatasertib plus paclitaxel for PIK3CA/AKT1/PTEN-altered hormone receptor-positive HER2-negative advanced breast cancer: primary results from cohort B of the IPATunity130 randomized phase 3 trial. Breast Cancer Res Treat. 2022 Feb;191(3):565-576. doi: 10.1007/s10549-021-06450-x. Epub 2021 Dec 3.