A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies

Neoplasm Metastasis Clinical Trial

Official title:

An Open-Label, Multicenter Extension Study of Trastuzumab Emtansine Administered as a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd-Sponsored Trastuzumab Emtansine Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00781612
• Other study ID #: TDM4529g
• Secondary ID: BO254302010-0210
• Status: Recruiting
• Phase: Phase 2
• Start date: October 16, 2008
• Est. completion date: September 20, 2029

Study information

• Verified date: June 2024
• Source: Genentech, Inc.
• Contact: Reference Study ID Number: BO25430 https://forpatients.roche.com
• Phone: 888-662-6728 (U.S. and Canada)
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a global, multicenter, open-label safety extension study. Participants receiving single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with other anti-cancer therapies in a Genentech / Roche-sponsored parent study who are active and receiving benefit at the closure of parent study are eligible for continued treatment in this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 720
• Est. completion date: September 20, 2029
• Est. primary completion date: September 20, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Completed single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment in the parent study or who continue to receive single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment at the time of the parent study closure and received the last study drug dose within the 6 weeks (42 days) prior to the first dose of study therapy on the extension study or Continue to receive treatment in the control arm of study BO21976/TDM4450g (NCT00679341) at the time of the parent study closure if the participant received the last dose of control arm study drug within the 6 weeks (42 days) prior to the first dose of control arm study therapy in the extension study
• Participants in the control arm from Study BO21976/TDM4450g whose disease progression has occurred during the transition interval between the parent study and this extension study may initiate trastuzumab emtansine treatment at the time of enrollment into study TDM4529g (NCT00781612)
• Expectation by the investigator that the participant may continue to benefit from additional single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment or Expectation of the investigator that the participant may continue to benefit from control arm treatment as given in study BO21976/TDM4450g and at the time of disease progression may benefit from single-agent trastuzumab emtansine treatment
• Women of childbearing potential and men with partners of childbearing potential, must be willing to use a highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception by the participants and/or partner, and to continue the use of contraception for the duration of study treatment and for at least 5 months after the final dose of atezolizumab (if applicable) or 7 months after the final dose of trastuzumab, trastuzumab emtansine or pertuzumab, whichever is later. Women must refrain from donating eggs during this same period
• Male participants whose partners are pregnant should use condoms for the duration of the pregnancy. Men must refrain from donating sperm during this same period

Exclusion Criteria:

• AEs leading to single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment discontinuation in the parent study
• Ongoing SAEs from the parent study
• Progressive disease on single-agent trastuzumab emtansine or a trastuzumab emtansine-containing regimen during the parent study or before starting the extension study, with the exception of participants from study TDM4688g (NCT00943670) with early disease progression who went on to receive pertuzumab + trastuzumab emtansine treatment and have not experienced further disease progression on the combination regimen
• Peripheral neuropathy of Grade greater than or equal to (>/=) 3 per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0, 4.0 or 5.0, as utilized in the parent study
• History of symptomatic congestive heart failure ([CHF]; New York Heart Association [NYHA] Classes II-IV), ventricular arrhythmia requiring treatment, current unstable angina, or history of myocardial infarction within 6 months prior to study entry
• Severe dyspnea at rest due to complications of advanced malignancy or current requirement for continuous oxygen therapy
• Current severe, uncontrolled systemic disease (for example [e.g.] clinically significant cardiovascular, pulmonary, or metabolic disease)
• Major surgical procedure or significant traumatic injury within 28 days prior to study entry or anticipation of the need for major surgery during the course of study treatment
• Current pregnancy or lactation
• History of receiving any investigational treatment or other systemic therapy directed at controlling cancer (e.g., chemotherapy, trastuzumab, etc.) since the participant's last study drug dose in the parent study
• History of hypersensitivity with previous trastuzumab emtansine or any agent used with trastuzumab emtansine in the parent study, precluding further dosing
• Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol

Related Conditions & MeSH terms

• Neoplasm Metastasis

Intervention

Drug:
• Docetaxel
Docetaxel will be administered as per local prescribing information.
• Paclitaxel
Paclitaxel will be administered as per local prescribing information.
• Pertuzumab
Pertuzumab will be administered intravenously at a dose of 420 milligrams (mg) no more frequently than every 3 weeks (Q3W) (or as directed in the parent study protocol if less than Q3W).
• Trastuzumab
Trastuzumab will be administered as per local prescribing information.
• Trastuzumab Emtansine
Trastuzumab emtansine will be administered as intravenous (IV) infusion. Participants on weekly dosing schedule of trastuzumab emtansine in parent study, may switch to Q3W schedule as per the clinical judgment of the investigator. The starting dose of Q3W schedule must not exceed 3.6 milligrams per kilograms (mg/kg).
• Atezolizumab
Atezolizumab will be administered at a dose of 1200 mg by IV infusion every three weeks (Q3W)

Locations

Country	Name	City	State
Australia	Peninsula and South Eastern Haematology and Oncology Group	Frankston	Victoria
Australia	Peter MacCallum Cancer Center	North Melbourne	Victoria
Austria	Klinik Favoriten; 1 Medizinische Abteilung	Wien
Belgium	UZ Gent	Gent
Belgium	Sint Augustinus Wilrijk, Apotheek	Wilrijk
Brazil	Trymed Clinical Research	Belo Horizonte	MG
Brazil	Clinica de Neoplasias Litoral	Itajai	SC
Brazil	Clinica de Oncologia de Porto Alegre - CliniOnco	Porto Alegre	RS
Brazil	Hospital Nossa Senhora da Conceicao	Porto Alegre	RS
Brazil	Hospital Sao Lucas - PUCRS	Porto Alegre	RS
Brazil	Santa Casa de Misericordia de Porto Alegre	Porto Alegre	RS
Brazil	Instituto Nacional de Cancer - INCa; Oncologia	Rio de Janeiro	RJ
Brazil	Nucleo de Oncologia da Bahia - NOB	Salvador, Bahia	BA
Brazil	Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia	Santo Andre	SP
Brazil	Hospital Perola Byington	Sao Paulo	SP
Bulgaria	Complex Oncology Center - Plovdiv First Internal Chemotherapy Department	Plovdiv
Bulgaria	SHATO - Sofia	Sofia
Canada	BC Cancer ? Kelowna (Sindi Ahluwalia Hawkins Centre)	Kelowna	British Columbia
Canada	Centre Hospitalier de l?Université de Montréal (CHUM)	Montreal	Quebec
Canada	Ottawa Regional Cancer Centre; Civic Hospital Division	Ottawa	Ontario
Canada	CHU de Québec ? Hôpital du Saint-Sacrement / ONCOLOGY	Quebec
Canada	Saskatoon Cancer Centre	Saskatoon	Saskatchewan
Canada	St. Michael'S Hospital	Toronto	Ontario
Canada	University Health Network; Princess Margaret Hospital; Medical Oncology Dept	Toronto	Ontario
Chile	Fundacion Arturo Lopez Perez	Santiago
China	Beijing Cancer Hospital	Beijing
China	The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)	Beijing
China	the First Hospital of Jilin University	Changchun
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University; Breast Tumor Center	Guangzhou City
China	Sun Yet-sen University Cancer Center	Guangzhou City
China	Zhejiang Provincial People's Hospital; Oncology& Breast	Hangzhou
China	Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department	Hangzhou City
China	Harbin Medical University Cancer Hospital	Harbin
China	Jiangsu Cancer Hospital	Nanjing City
China	Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)	Nanjing City
China	Fudan University Shanghai Cancer Center	Shanghai City
Croatia	Clinical Hospital Centre Zagreb	Zagreb
Czechia	Masarykuv onkologicky ustav	Brno
Czechia	Fakultni nemocnice Olomouc; Onkologicka klinika	Olomouc
Czechia	Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika	Praha 2
Denmark	Odense Universitetshospital, Onkologisk Afdeling R	Odense C
Denmark	Vejle Sygehus; Onkologisk Afdeling	Vejle
France	Centre Francois Baclesse; Comite Sein	Caen
France	Centre Georges Francois Leclerc; Oncologie 3	Dijon
France	Centre Hospitalier Departemental Les Oudairies	La Roche Sur Yon
France	Institut Paoli Calmettes; Oncologie Medicale	Marseille
France	Institut régional du Cancer Montpellier	Montpellier
France	Hopital Tenon; AP HP	Paris
France	Institut Curie; Oncologie Medicale	Paris
France	Ico Rene Gauducheau; Oncologie	Saint Herblain
France	Institut Curie - Hopital Rene Huguenin	Saint-Cloud
Germany	Studienzentrum Aschaffenburg	Aschaffenburg
Germany	Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche	Berlin
Germany	HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe	Berlin
Germany	Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum	Essen
Germany	Uniklinik Köln, Klinik und Poliklinik und Geburtshilfe; Brustzentrum Köln	Köln
Germany	Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde	Muenchen
Germany	Rotkreuzklinikum München; Frauenklinik	Muenchen
Germany	Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher	Stralsund
Germany	Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker	Würzburg
Guatemala	Grupo Angeles	Guatemala City
Hong Kong	Queen Mary Hospital; Dept of Medicine	Hong Kong
Hungary	Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika	Budapest
Hungary	Szent Margit Hospital; Dept. of Oncology	Budapest
Hungary	Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika	Debrecen
Hungary	Markusovszky Hospital	Szombathely
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Kaplan Medical Center; Oncology Inst.	Rehovot
Israel	Tel Aviv Sourasky Medical Ctr; Oncology	Tel Aviv
Italy	RCCS - Centro di Riferimento; Oncologia Medica B	Aviano (PN)	Friuli-Venezia Giulia
Italy	Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico	Candiolo	Piemonte
Italy	Campus Universitario S.Venuta; Centro Oncologico T.Campanella	Catanzaro	Calabria
Italy	IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica	Meldola	Emilia-Romagna
Italy	IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica	Meldola	Emilia-Romagna
Italy	Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1	Milano	Lombardia
Italy	Istituto Europeo Di Oncologia	Milano	Lombardia
Italy	Humanitas Istituto Clinico Catanese S.p.A	Misterbianco (CT)	Sicilia
Italy	Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica	Napoli	Campania
Italy	Ospedale Regionale Di Parma; Divisione Di Oncologia Medica	Parma	Emilia-Romagna
Italy	A.O. Universitaria Pisana; Oncologia	Pisa	Toscana
Italy	Ospedale San Carlo; Day Hospital Oncologia Medica	Potenza	Basilicata
Italy	Ospedale Misericordia E Dolce; Oncologia Medica	Prato	Toscana
Italy	Ospedale Civile; Oncologia Medica	Sassari	Sardegna
Italy	Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia	Udine	Friuli-Venezia Giulia
Japan	Hiroshima University Hospital; Breast Surgery	Hiroshima
Japan	Hyogo Cancer Center; Breast Surgery	Hyogo
Japan	Saitama Medical University International Medical Center; Breast Oncology	Saitama
Korea, Republic of	Kyungpook National University Medical Center; Oncology	Daegu
Korea, Republic of	National Cancer Center	Goyang-si
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul National University Hospital; Department of Oncology	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Mexico	Centro de Investigacion; Clinica Del Pacifico	Acapulco	Guerrero
Mexico	Instituto Nacional de Cancer	D.f.	Mexico CITY (federal District)
Mexico	Consultorio de Medicina Especializada	Mexico	Mexico CITY (federal District)
Mexico	Oaxaca Site Management Organization	Oaxaca de Juárez	Oaxaca
New Zealand	Auckland city hospital; Auckland Regional Cancer Centre and Blood Service	Auckland
North Macedonia	Private Health Organization Acibadem Sistina Hospital	Skopje
Norway	Oslo Universitetssykehus HF; Radiumhospitalet	Oslo
Panama	The Panama Clinic	Panama
Peru	Instituto Nacional de Enfermedades Neoplasicas	Lima
Peru	Instituto;Oncologico Miraflores	Lima
Philippines	Cebu Cancer Institute; Perpetual Succour Hospital	Cebu City
Philippines	Veterans Memorial Medical Ctr; Cancer Research Centre	Quezon City
Philippines	Cardinal Santos Medical Center	San Juan
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	?wi?tokrzyskie Centrum Onkologii; Dzia? Chemioterapii	Kielce
Poland	COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej	Lublin
Poland	Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii	Otwock
Poland	Wielkopolskie Centrum Onkologii; Oddzial Chemioterapii	Poznan
Poland	Wojewódzki Szpital Specjalistyczny Nr 3	Rybnik
Poland	Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Nowotworow Piersi i Chirurgii Rekonstr	Warszawa
Portugal	Hospital da Luz; Departamento de Oncologia Medica	Lisboa
Portugal	Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia	Porto
Portugal	IPO do Porto; Servico de Oncologia Medica	Porto
Russian Federation	City Clinical Oncology Hospital	Moscow	Moskovskaja Oblast
Russian Federation	Blokhin Cancer Research Center; Combined Treatment	Moskva	Moskovskaja Oblast
Russian Federation	City Oncology Dispensary	St Petersburg	Sankt Petersburg
Russian Federation	FSBI?National Medical Research Center of Oncology named after N.N.Petrov? MHRF	St Petersburg	Sankt Petersburg
Russian Federation	SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary	Stavropol
Russian Federation	Bashkirian Republican Clinical Oncology Dispensary	UFA	Baskortostan
Singapore	National University Hospital; National University Cancer Institute, Singapore (NCIS)	Singapore
Slovenia	Institute of Oncology Ljubljana	Ljubljana
Spain	Hospital del Mar; Servicio de Oncologia	Barcelona
Spain	Hospital Duran i Reynals; Oncologia	Barcelona
Spain	Hospital San Pedro De Alcantara; Servicio de Oncologia	Caceres
Spain	Hospital General Universitario de Elche; Servicio de Oncologia	Elche	Alicante
Spain	Hospital de Jerez de la Frontera; Servicio de Oncologia	Jerez de La Frontera	Cadiz
Spain	Hospital Severo Ochoa; Servicio de Oncologia	Leganes	Madrid
Spain	Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia	Lerida
Spain	Hospital General Universitario Gregorio Marañon; Servicio de Oncologia	Madrid
Spain	Hospital Ramon y Cajal; Servicio de Oncologia	Madrid
Spain	Hospital Universitario La Paz; Servicio de Oncologia	Madrid
Spain	Hospital de Donostia; Servicio de Oncologia Medica	San Sebastian	Guipuzcoa
Spain	Hospital Univ Vall d'Hebron; Servicio de Oncologia	Sant Andreu de La Barca	Barcelona
Spain	Hospital Universitario Virgen del Rocio; Servicio de Oncologia	Sevilla
Spain	Hospital Universitario Miguel Servet; Servicio Oncologia	Zaragoza
Sweden	Mälarsjukhuset; Onkologkliniken Sörmland	Eskilstuna
Switzerland	Universitätsspital Zürich	Zürich
Taiwan	Chi-Mei Medical Center	Tainan
Taiwan	National Cheng Kung Uni Hospital; Surgery	Tainan
Taiwan	National Taiwan Uni Hospital; Dept of Oncology	Taipei
Taiwan	Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology	Taipei City
Taiwan	Chang Gung Memorial Hospital - Linkou	Taoyuan
Thailand	Bumrungrad International Hosp	Bangkok
Thailand	Rajavithi Hospital; Division of Medical Oncology	Bangkok
United Kingdom	Ninewells Hospital	Dundee
United Kingdom	Western General Hospital; Clinical Oncology	Edinburgh
United Kingdom	Diana Princess of Wales Hosp.	Grimsby
United Kingdom	Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust	Lancaster
United Kingdom	Royal Free Hospital; Dept of Oncology	London
United Kingdom	Christie Hospital NHS Trust	Manchester
United Kingdom	Mount Vernon Hospital	Middlesex
United Kingdom	Mount Vernon Cancer Centre	Northwood
United Kingdom	Nottingham City Hospital; Oncology	Nottingham
United Kingdom	Poole General Hospital	Poole
United Kingdom	Queen's Hospital; Oncology	Romford
United Kingdom	Abertawe and Bro Morgannwg NHS Trust; Clinical Researdh Institute	Swansea
United Kingdom	Royal Cornwall Hospital	Truro
United States	Anne Arundel Medical Center; Anne Arundel Health System	Annapolis	Maryland
United States	Univ of Colorado Canc Ctr	Aurora	Colorado
United States	University of Colorado	Aurora	Colorado
United States	Johns Hopkins Univ Med Center	Baltimore	Maryland
United States	Texas Oncology	Bedford	Texas
United States	Hematology-Oncology; Associates of the Quad Cities	Bettendorf	Iowa
United States	Dana Farber Cancer Institute; Breast Oncology	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Oncology Assoc of Cedar Rapids; Iowa Cancer Care	Cedar Rapids	Iowa
United States	Sarah Cannon Research Institute / Tennessee Oncology	Chattanooga	Tennessee
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.	Columbus	Ohio
United States	Texas Oncology - Dallas Presbyterian Hospital	Dallas	Texas
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	City of Hope National Medical Center	Duarte	California
United States	Florida Cancer Specialists; Department of Oncology	Fort Myers	Florida
United States	Sarah Cannon Research Institute / Tennessee Oncology	Germantown	Tennessee
United States	Carolina Oncology Specialists, PA - Hickory	Hickory	North Carolina
United States	Millennium Research & Clinical Development	Houston	Texas
United States	Indiana University Melvin and Bren Simon Cancer Center	Indianapolis	Indiana
United States	US Oncology	Irving	Texas
United States	US Oncology Research Pharm.	Irving	Texas
United States	Baptist - MD Anderson Cancer Center	Jacksonville	Florida
United States	Capitol Comprehensive CA Care	Jefferson City	Missouri
United States	NS-Long Island Jewish Hlth Sys	Lake Success	New York
United States	Rocky Mountain Cancer Center - Denver	Littleton	Colorado
United States	St. Barnabas Health Care Sys	Livingston	New Jersey
United States	Can Care Assoc Med Group Inc; Beach Cities Offices	Los Angeles	California
United States	Comp Cancer Centers of Nevada	Los Angeles	California
United States	Northwest Georgia Oncology Centers PC - Marietta	Marietta	Georgia
United States	Loyola University Med Center	Maywood	Illinois
United States	Univ of Miami Health Systems	Miami	Florida
United States	Minnesota Oncology Hematology, Pa	Minneapolis	Minnesota
United States	University of Minnesota.	Minneapolis	Minnesota
United States	Vanderbilt Ingram Cancer Ctr	Nashville	Tennessee
United States	Laura and ISAAC Perlmutter Cancer Center at NYU Langone.	New York	New York
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Christina Care Institutional Review Board	Newark	Delaware
United States	Memorial Cancer Institute at Memorial West	Pembroke Pines	Florida
United States	Illinois Cancer Care	Peoria	Illinois
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	USO	Plano	Texas
United States	Northwest Cancer Specialists - Portland (N Broadway)	Portland	Oregon
United States	Kootenai Cancer Center	Post Falls	Idaho
United States	Mayo Clinic - Rochester	Rochester	Minnesota
United States	St. John's Mercy Medical Ctr; David C. Pratt Cancer Center	Saint Louis	Missouri
United States	Florida Cancer Specialists (St. Petersburg ? St. Anthony?s Professional Building)	Saint Petersburg	Florida
United States	Cancer Therapy & Research Center	San Antonio	Texas
United States	Univ of Calif, San Francisco; Breast Cancer Center	San Francisco	California
United States	Central Coast Medical Oncology	Santa Maria	California
United States	UCLA Oncology Office; Oncology	Santa Monica	California
United States	New England Cancer Specialists	Scarborough	Maine
United States	Uni of Washington Medical Center; Dept of Oncology	Seattle	Washington
United States	Univ of WA Medical Center	Seattle	Washington
United States	Mercy Clinic Cancer & Hematology	Springfield	Missouri
United States	Stanford Cancer Institute	Stanford	California
United States	Northwest Medical Specialties	Tacoma	Washington
United States	Florida Cancer Specialists - Tampa (Dr. MLK Blvd)	Tampa	Florida
United States	US Oncology Research, Inc.	The Woodlands	Texas
United States	USO - Tyler Cancer Ctr	Tyler	Texas
United States	Kaiser Permanente; Oncology Clinical Trials	Vallejo	California
United States	Kaiser Permanente - Walnut Creek	Walnut Creek	California
United States	Clinical Research Alliance	Westbury	New York
United States	Cancer Center of Kansas	Wichita	Kansas
United States	Midwestern Regional Medical Center; Office of Research	Zion	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Genentech, Inc.	Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Croatia,  Czechia,  Denmark,  France,  Germany,  Guatemala,  Hong Kong,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  New Zealand,  North Macedonia,  Norway,  Panama,  Peru,  Philippines,  Poland,  Portugal,  Russian Federation,  Singapore,  Slovenia,  Spain,  Sweden,  Switzerland,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)		Baseline up to 30 days after last dose of study drug administration (up to approximately 14 years)
Primary	Percentage of Participants With Adverse Events Leading to Study Treatment Discontinuation or Dose Reduction		Baseline up to 30 days after last dose of study drug administration (up to approximately 14 years)