A Study of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer
A Phase III, Double-blind, Placebo-controlled, Randomized Study of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Patients With Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer
2 other identifiers
interventional
242
35 countries
177
Brief Summary
This study evaluated the efficacy and safety of ipatasertib in combination with atezolizumab and paclitaxel in locally advanced or metastatic Triple-Negative Breast Cancer (TNBC) previously untreated in this setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2019
Typical duration for phase_3
177 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2019
CompletedStudy Start
First participant enrolled
November 25, 2019
CompletedFirst Posted
Study publicly available on registry
November 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2023
CompletedResults Posted
Study results publicly available
March 27, 2024
CompletedMarch 27, 2024
February 1, 2024
3.3 years
November 7, 2019
February 26, 2024
February 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
PFS was defined as the time from randomization to the first occurrence of disease progression as determined locally by RECIST or death from any cause during treatment, whichever occurs first.
From Randomization to disease progression, study completion, or death (up to 39 months)
Overall Survival (OS)
OS was defined as the time from randomization to the time of death from any cause on study.
From randomization up to study completion or death (Up to 39 months)
Secondary Outcomes (1)
Number of Participants With Adverse Events (AEs)
Up to 39 months
Study Arms (5)
Cohort 1 Arm A: Ipatasertib + Atezolizumab + Paclitaxel
EXPERIMENTALTNBC participants with programmed death-ligand 1 (PD-L1) non-positive received a combination of paclitaxel, 80 milligrams per meter square (mg/m\^2), intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, orally (PO), once daily (QD), from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
Cohort 1 Arm B: Ipatasertib + Placebo + Paclitaxel
EXPERIMENTALTNBC participants with PD-L1 non-positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab-matching placebo, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
Cohort 1 Arm C: Placebo + Placebo + Paclitaxel
EXPERIMENTALTNBC participants with PD-L1 non-positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib-matching placebo, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab-matching placebo, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
Cohort 2 Arm A: Ipatasertib + Atezolizumab + Paclitaxel
EXPERIMENTALTNBC participants with PD-L1 positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
Cohort 2 Arm B: Placebo+ Atezolizumab + Paclitaxel
EXPERIMENTALTNBC participants with PD-L1 positive received a combination of paclitaxel, 80 mg/m\^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib-matching placebo, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
Interventions
Atezolizumab was administered as per the dosage regimen mentioned in arm descriptions.
Ipatasertib was administered as per the dosage regimen mentioned in arm descriptions.
Paclitaxel was administered as per the dosage regimen mentioned in arm descriptions.
Placebo was administered as per the dosage regimen mentioned in arm descriptions.
Placebo was administered as per the dosage regimen mentioned in arm descriptions.
Eligibility Criteria
You may qualify if:
- Willingness and ability to complete all study-related assessments, including Participant-Reported Outcome (PRO) assessments, in the investigator's judgement.
- Adequate hematologic and organ function within 14 days before the first study treatment on Day 1 of Cycle 1.
- Life expectancy of at least 6 months.
- Measurable disease according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v 1.1).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- 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.
- Appropriate candidate for paclitaxel monotherapy if tumor programmed death-ligand 1 (PD-L1) status is unknown or non-positive; appropriate candidate for paclitaxel and atezolizumab if tumor PD-L1 status is positive.
- Histologically documented triple-negative adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to resection with curative intent.
You may not qualify if:
- Inability to comply with study and follow-up procedures.
- History of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills.
- Severe infection within 4 weeks prior to initiation of study treatment (including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia) as well as those who have received treatment with therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to initiation of study treatment.
- Known human immunodeficiency virus (HIV) infection (there must be a negative HIV test at screening).
- Known clinically significant history of liver disease consistent with Child-Pugh Class B or C.
- Current treatment with anti-viral therapy for hepatitis B virus (HBV).
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of Cycle 1 or anticipation of need for a major surgical procedure during the study.
- Pregnancy or breastfeeding, or intention to become pregnant during the study or within 28 days after the final dose of ipatasertib or (/) placebo, 5 months after the final dose of atezolizumab/placebo, and 6 months after the final dose of paclitaxel whichever occurs later.
- New York Heart Association Class II, III, or IV heart failure, left ventricular ejection fraction less than (\<) 50 percent (%), or active ventricular arrhythmia requiring medication.
- Current unstable angina or history of myocardial infarction within 6 months prior to Day 1 of Cycle 1.
- Congenital long QT syndrome or screening QT interval corrected through use Fridericia's formula (QTcF) greater than (\>) 480 milliseconds (ms).
- Current treatment with medications used at doses known to cause clinically relevant prolongation of QT/QTc interval.
- History or presence of an abnormal ECG that is clinically significant in the investigator's opinion (including complete left bundle branch block, second- or third-degree heart block, or evidence of prior myocardial infarction).
- Requirement for chronic corticosteroid therapy of \> 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressant agents for a chronic disease.
- Treatment with approved or investigational cancer therapy within 14 days prior to Day 1 of Cycle 1.
- +26 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (182)
USA Mitchell Cancer Institute
Mobile, Alabama, 36688, United States
Highlands Oncology Group
Springdale, Arkansas, 72762, United States
UCLA
Los Angeles, California, 90095, United States
Kaiser Permanente-SCPMG; Oncology Research
San Diego, California, 92108, United States
Stanford Cancer Center
Stanford, California, 94305-5820, United States
Kaiser Permanente - Franklin
Denver, Colorado, 80205, United States
Stamford Hospital; BCC, MOHR
Stamford, Connecticut, 06904, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
Memorial Healthcare System - Memorial Regional Hospital
Hollywood, Florida, 33021, United States
Memorial Cancer Institute at Memorial West
Pembroke Pines, Florida, 33028, United States
Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Nancy N. and J.C. Lewis Cancer & Research Pavillion -St. Josephs / Candler Health System-CCD PRIME
Savannah, Georgia, 31405, United States
Rush University
Chicago, Illinois, 60612, United States
Ochsner Clinic Foundation
Baton Rouge, Louisiana, 70809, United States
Ochsner Health System
New Orleans, Louisiana, 70121, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Mercy Medical Center
Baltimore, Maryland, 21202, United States
Medstar Franklin Square Medical Center
Baltimore, Maryland, 21237, United States
St. Joseph Mercy Hospital; Cancer Care Center.
Ann Arbor, Michigan, 48106, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Jackson Oncology Associates, PLLC
Jackson, Mississippi, 39202, United States
CHI Health Saint Francis; Oncology
Grand Island, Nebraska, 68803, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Hackensack Univ Med Ctr
Hackensack, New Jersey, 07601, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Kaiser Permanente - Portland
Portland, Oregon, 97227, United States
Oregon Health and Science University
Portland, Oregon, 97229, United States
Charleston Oncology, P .A
Charleston, South Carolina, 29414, United States
Greenville Health System; Cancer Center
Greenville, South Carolina, 29605-4292, United States
The West Clinic; West Cancer Center
Germantown, Tennessee, 38138, United States
Vanderbilt Univ Medical Ctr
Nashville, Tennessee, 37203, United States
Fundación CENIT para la Investigación en Neurociencias
Buenos Aires, C1125ABD, Argentina
Inst. Angel Roffo; Haematology
Buenos Aires, C1417DTB, Argentina
Hospital Britanico
Ciudad Autonoma Bs As, C1280AEB, Argentina
Instituto Medico Rio Cuarto
Córdoba, X5800AEU, Argentina
Centro Oncologico Riojano Integral (CORI)
La Rioja, F5300COE, Argentina
Fundacion Scherbovsky
Mendoza, M5500AYB, Argentina
Macquarie University Hospital
Macquarie Park, New South Wales, 2109, Australia
Mid North Coast Cancer Institute
Port Macquarie, New South Wales, 2444, Australia
Royal North Shore Hospital; Department of Medical Oncology
St Leonards, New South Wales, 2065, Australia
Calvary Mater Newcastle; Medical Oncology
Waratah, New South Wales, 2298, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Adelaide Cancer Centre
Kurralta Park, South Australia, 5037, Australia
Monash Health Monash Medical Centre
Clayton, Victoria, 3168, Australia
Peter MacCallum Cancer Centre; Medical Oncology
Melbourne, Victoria, 3000, Australia
Sunshine Hospital; Oncology Research
St Albans, Victoria, Australia
St John of God Hospital; Bendat Cancer Centre
Subiaco, Western Australia, 6008, Australia
Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie
Innsbruck, 6020, Austria
Ordensklinikum Linz Barmherzige Schwestern; Interne 1 - Hämato-Onkologie
Linz, 4010, Austria
Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU
Salzburg, 5020, Austria
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I
Vienna, 1090, Austria
AZ Maria Middelares
Ghent, 9000, Belgium
Jessa Zkh (Campus Virga Jesse)
Hasselt, 3500, Belgium
Hospital Sao Rafael - HSR
Salvador, Estado de Bahia, 41253-190, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
São Paulo, São Paulo, 01317-001, Brazil
Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA
São Paulo, São Paulo, 04014-002, Brazil
MHAT Nadezhda
Sofia, 1330, Bulgaria
Cross Cancer Institute ; Dept of Medical Oncology
Edmonton, Alberta, T6G 1Z2, Canada
Fraser Valley Centre British Columbia Cancer Agency
Surrey, British Columbia, V3V 1Z2, Canada
Cancer Care Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Royal Victoria Hospital
Barrie, Ontario, L4M 6M2, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K2H 6C2, Canada
Jewish General Hospital; Research Unit
Montreal, Quebec, H3T 1E2, Canada
McGill University; Glen Site; Oncology
Montreal, Quebec, H4A 3J1, Canada
Hopital du Saint Sacrement
Québec, Quebec, G1S 4L8, Canada
Clinica del Country
Bogotá, 11001, Colombia
Oncólogos de Occidente
Pereira, 600004, Colombia
Clinica CIMCA
San José, 10103, Costa Rica
Masaryk?v onkologický ústav; Klinika komplexní onkologické pé?e
Brno, 656 53, Czechia
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc, 779 00, Czechia
Herlev Hospital; Afdeling for Kræftbehandling
Herlev, 2730, Denmark
Odense Universitetshospital, Onkologisk Afdeling R
Odense C, 5000, Denmark
Docrates Cance Center
Helsinki, 00180, Finland
KYS Sadesairaala; Syopatautien poliklinikka
Kuopio, 70210, Finland
VAASAN KESKUSSAIRAALA; Onkologian poliklinikka
Vaasa, 65130, Finland
Centre Eugene Marquis; Service d'oncologie
Rennes, 35042, France
Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.
Kifissia, 145 64, Greece
Euromedical General Clinic of Thessaloniki; Oncology Department
Thessaloniki, 546 45, Greece
Queen Mary Hospital; Dept of Medicine
Hong Kong, Hong Kong
Tuen Mun Hospital; Clinical Onc
Hong Kong, Hong Kong
Prince of Wales Hospital; Department of Clinical Onocology
Shatin, Hong Kong
Sahyadri Super Specialty Hospital Hadapsar
Pune, Maharashtra, 411028, India
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
Napoli, Campania, 80131, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola, Emilia-Romagna, 47014, Italy
ASU FC S. M. DELLA MISERICORDIA; Oncologia
Udine, Friuli Venezia Giulia, 33100, Italy
ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica
Brescia, Lombardy, 25123, Italy
ASST DI LECCO; Oncologia Medica
Lecco, Lombardy, 23900, Italy
IRCCS Istituto Clinico Humanitas; Oncologia
Rozzano (MI), Lombardy, 20089, Italy
Ospedale Civile; Unita Operativa Di Oncologia Medica
Livorno, Tuscany, 57100, Italy
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
Padua, Veneto, 35128, Italy
Aichi Cancer Center Hospital
Aichi, 464-8681, Japan
Fukushima Medical University Hospital
Fukushima, 960-1295, Japan
Gunma Prefectural Cancer Center
Gunma, 373-8550, Japan
Hiroshima University Hospital
Hiroshima, 734-8551, Japan
Kanagawa Cancer Center
Kanagawa, 241-8515, Japan
Kumamoto Shinto General Hospital
Kumamoto, 862-8655, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
Osaka International Cancer Institute
Osaka, 541-8567, Japan
Investigacion Oncofarmaceutica
La Paz, Baja California Sur, 23040, Mexico
Health Pharma Professional Research
Mexico City, Mexico CITY (federal District), 03100, Mexico
Christus Muguerza Clinica Vidriera
Monterrey, Nuevo León, 64570, Mexico
Auckland City Hospital, Cancer and Blood Research
Auckland, 1023, New Zealand
Tauranga Hospital, Clinical Trials Unit; BOP Clinical School
Tauranga, 3112, New Zealand
Wellington Regional Hospital; Clinical Trials Unit
Wellington, 6021, New Zealand
Centro Medico Monte Carmelo
Arequipa, 04001, Peru
Instituto Regional de Enfermedades Neoplasicas
Arequipa, 04002, Peru
Unidad de Investigación Oncologica; Hospital Nacional Daniel Alcides Carrion
Lima, 07016, Peru
Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel
Lima, 15088, Peru
Hospital Arzobispo Loayza
Lima, 1, Peru
Oncosalud Sac; Oncología
Lima, 41, Peru
Instituto Nacional de Enfermedades Neoplasicas
Lima, Lima 34, Peru
Clinica Ricardo Palma
San Isidro, Lima 27, Peru
Instyt. Centrum Zdrowia Matki Polki; Klinika Chirurgii Onk. Chorób Piersi z Podod. Onko Klinicznej
?ód?, 93-338, Poland
Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; Centr.Diagn.i Lecz.Chor.Piersi
Gliwice, 44-101, Poland
Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
Krakow, 30-688, Poland
Wielkopolskie Centrum Onkologii
Poznan, 61-866, Poland
Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Nowotworow Piersi i Chirurgii Rekonstr
Warsaw, 02-781, Poland
Hospital da Luz; Departamento de Oncologia Medica
Lisbon, 1500-650, Portugal
Hospital de Santa Maria; Servico de Oncologia Medica
Lisbon, 1649-035, Portugal
Hospital Beatriz Angelo; Departamento de Oncologia
Loures, 2674-514, Portugal
Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia
Porto, 4099-001, Portugal
IPO do Porto; Servico de Oncologia Medica
Porto, 4200-072, Portugal
Oncology Center Sf. Nectarie
Craiova, 200347, Romania
Arkhangelsk Regional Clinical Oncology Dispensary
Arkhangelsk, Arhangelsk, 163045, Russia
University ?linic of headaches
Moscow, Moscow Oblast, 121467, Russia
P.A. Gertsen Cancer Research Inst. ; Chemotherapy Dept
Moscow, Moscow Oblast, 125284, Russia
SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"
Moskva, Moscow Oblast, 111123, Russia
Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF
Moskva, Moscow Oblast, 115478, Russia
FSAI Treatment and rehabilitation Centre Ministry of Health; Clinical research and chemotherapy.
Moskva, Moscow Oblast, 125367, Russia
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
Saint Petersburg, Sankt-Peterburg, 197758, Russia
Clinical Oncology Dispensary of Ministry of Health of Tatarstan
Kazan', Tatarstan Republic, 420029, Russia
Limited Liability Company "RC Medical"
Novosibirsk, 630005, Russia
National Cancer Centre; Medical Oncology
Singapore, 168583, Singapore
National Hospital; Oncotherapy Dept
Bloemfontein, 9301, South Africa
Cancercare
George, 6529, South Africa
Wits Clinical Research
Johannesberg, 2013, South Africa
Cancercare
Port Elizabeth, 6045, South Africa
Wilgers Oncology Centre
Pretoria, 0001, South Africa
Kyungpook National University Medical Center
Daegu, 41404, South Korea
National Cancer Center
Goyang-si, 10408, 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
Seoul St Mary's Hospital
Seoul, 06591, South Korea
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Sant Andreu de la Barca, Barcelona, 08740, Spain
Hospital Provincial de Castellon; Servicio de Oncologia
Castellon, Castellon, 12002, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
A Coruña, LA Coruña, 15006, Spain
Hospital Universitario Puerta de Hierro; Servicio de Oncologia
Majadahonda, Madrid, 28222, Spain
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
Barcelona, 08036, Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid, 28007, Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, 28034, Spain
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Madrid, 28040, Spain
Centro Integral Oncologico Clara Campal; Servicio de Oncología
Madrid, 28050, Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Málaga, 29010, Spain
Hospital Clínico Universitario de Valencia; Servicio de Oncología
Valencia, 46010, Spain
Universitätsspital Basel
Basel, 4031, Switzerland
Universitätsspital Zürich Gynäkologische Klinik; Klinik für Gynäkologie
Zurich, 8091, Switzerland
China Medical University Hospital; Surgery
Taichung, 404, Taiwan
VETERANS GENERAL HOSPITAL; Department of General Surgery
Taipei, 00112, Taiwan
National Taiwan Uni Hospital; General Surgery
Taipei, 100, Taiwan
Chang Gung Memorial Hosipital at Linkou
Taoyuan, 333, Taiwan
Chulalongkorn Hospital; Medical Oncology
Bangkok, 10330, Thailand
Rajavithi Hospital; Division of Medical Oncology
Bangkok, 10400, Thailand
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
Bangkok, 10700, Thailand
Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial
Chiang Mai, 50200, Thailand
Khonkaen Hospital
Khonkaen, 40000, Thailand
Songklanagarind Hospital; Department of Oncology
Songkhla, 90110, Thailand
Memorial Ankara Hastanesi
Ankara, 06520, Turkey (Türkiye)
Medipol University Medical Faculty; Oncology Department
Istanbul, 34214, Turkey (Türkiye)
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Sihhiye/Ankara, 06230, Turkey (Türkiye)
SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU; Purulent Surgery department
Kharkiv, Kharkiv Governorate, 61018, Ukraine
Regional Oncology Center; Department of Mammology
Chernihiv, 14029, Ukraine
Chemotherapy SI Dnipropetrovsk MA of MOHU
Dnipropetrovsk, 49102, Ukraine
ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department
Kryvyi Rih, 50048, Ukraine
MI Kyiv Regional Council Kyiv Regional Oncological Dispensary; Department of Mammology
Kyiv, 04107, Ukraine
Municipal Institution Odesa Regional Clinical Hospital
Odesa, 65025, Ukraine
RCI Sumy Regional Clinical Oncological Dispensary
Sumy, 40005, Ukraine
BEATSON WEST OF SCOTLAND CANCER CENTRE; Clinical Research Unit ? Level 1
Glasgow, G12 0YN, United Kingdom
The Royal Marsden Hospital, Fulham
London, SW3 6JJ, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2019
First Posted
November 26, 2019
Study Start
November 25, 2019
Primary Completion
February 28, 2023
Study Completion
February 28, 2023
Last Updated
March 27, 2024
Results First Posted
March 27, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).