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| ID | Type | Description | Link |
|---|---|---|---|
| BO25430 | Other Identifier | Hoffmann-La Roche | |
| 2010-021067-32 | EudraCT Number | ||
| 2023-503479-79-00 | Other Identifier | EU CT |
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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trastuzumab Emtansine | Experimental | Participants will receive trastuzumab emtansine either as a single agent or in combination with other anti-cancer therapy (atezolizumab, paclitaxel, trastuzumab and docetaxel). Participants will receive the same dose and schedule on Cycle 1, Day 1 at which it was given at the end of the parent study. Study drug will be administered in 21-day cycles or weekly, depending on the schedule used in the parent study. Participants will receive study treatment until disease progression or unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | Docetaxel will be administered as per local prescribing information. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010 | United States | ||
| Can Care Assoc Med Group Inc |
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| Paclitaxel | Drug | Paclitaxel will be administered as per local prescribing information. |
|
| Pertuzumab | Drug | 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). |
|
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| Trastuzumab | Drug | Trastuzumab will be administered as per local prescribing information. |
|
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| Trastuzumab Emtansine | Drug | 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). |
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| Atezolizumab | Drug | Atezolizumab will be administered at a dose of 1200 mg by IV infusion every three weeks (Q3W) |
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|
| Redondo Beach |
| California |
| 90277 |
| United States |
| Univ of Calif, San Francisco | San Francisco | California | 94115 | United States |
| Central Coast Medical Oncology | San Luis Obispo | California | 93454 | United States |
| UCLA Oncology Office | Santa Monica | California | 90404 | United States |
| Stanford Cancer Institute | Stanford | California | 94305-5456 | United States |
| Kaiser Permanente - Walnut Creek | Walnut Creek | California | 94596 | United States |
| Univ of Colorado Canc Ctr | Aurora | Colorado | 80045 | United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| Rocky Mountain Cancer Center - Denver | Denver | Colorado | 80220 | United States |
| Christina Care Institutional Review Board | Newark | Delaware | 19713 | United States |
| Florida Cancer Specialists | Fort Myers | Florida | 33916 | United States |
| Memorial Cancer Institute at Memorial West | Pembroke Pines | Florida | 33028 | United States |
| Florida Cancer Specialists (St. Petersburg ? St. Anthony?s Professional Building) | St. Petersburg | Florida | 33705 | United States |
| Florida Cancer Specialists - Tampa (Dr. MLK Blvd) | Tampa | Florida | 33607 | United States |
| Northwest Georgia Oncology Centers PC - Marietta | Marietta | Georgia | 30060 | United States |
| Kootenai Cancer Center | Post Falls | Idaho | 83854 | United States |
| Loyola University Med Center | Maywood | Illinois | 60153 | United States |
| Illinois Cancer Care | Peoria | Illinois | 61615 | United States |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| Hematology-Oncology | Bettendorf | Iowa | 52722 | United States |
| Oncology Assoc of Cedar Rapids | Cedar Rapids | Iowa | 52403 | United States |
| Anne Arundel Medical Center | Annapolis | Maryland | 21401 | United States |
| Johns Hopkins Univ Med Center | Baltimore | Maryland | 21231-1000 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Minnesota Oncology Hematology, Pa | Minneapolis | Minnesota | 55407 | United States |
| University of Minnesota. | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | United States |
| Mercy Clinic Cancer & Hematology | Springfield | Missouri | 65804 | United States |
| St. John's Mercy Medical Ctr | St Louis | Missouri | 63141 | United States |
| Comp Cancer Centers of Nevada | Las Vegas | Nevada | 89148 | United States |
| St. Barnabas Health Care Sys | Livingston | New Jersey | 07039 | United States |
| Clinical Research Alliance | Lake Success | New York | 11042 | United States |
| NS-Long Island Jewish Hlth Sys | Lake Success | New York | 11042 | United States |
| Laura and ISAAC Perlmutter Cancer Center at NYU Langone. | New York | New York | 10016 | United States |
| Carolina Oncology Specialists, PA - Hickory | Hickory | North Carolina | 28602 | United States |
| The Mark H. Zangmeister Ctr | Columbus | Ohio | 43219 | United States |
| Northwest Cancer Specialists - Portland (N Broadway) | Portland | Oregon | 97227 | United States |
| Sarah Cannon Research Institute / Tennessee Oncology | Chattanooga | Tennessee | 37404 | United States |
| Sarah Cannon Research Institute / Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| Texas Oncology | Bedford | Texas | 76022 | United States |
| Texas Oncology - Dallas Presbyterian Hospital | Dallas | Texas | 75231 | United States |
| USO | Plano | Texas | 75075-7787 | United States |
| Cancer Therapy & Research Center | San Antonio | Texas | 78229 | United States |
| USO - Tyler Cancer Ctr | Tyler | Texas | 75702 | United States |
| Uni of Washington Medical Center | Seattle | Washington | 98109-1023 | United States |
| Univ of WA Medical Center | Seattle | Washington | 98109 | United States |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | United States |
| Peninsula and South Eastern Haematology and Oncology Group | Frankston | Victoria | 3199 | Australia |
| Peter MacCallum Cancer Center | Melbourne | Victoria | 3000 | Australia |
| UZ Gent | Ghent | 9000 | Belgium |
| ZAS Sint Augustinus Wilrijk, Pharmacy | Wilrijk | 2610 | Belgium |
| Clinica de Oncologia de Porto Alegre - CliniOnco | Porto Alegre | Rio Grande do Sul | 90430-090 | Brazil |
| Hospital Nossa Senhora da Conceicao | Porto Alegre | Rio Grande do Sul | 91350-200 | Brazil |
| Clinica de Neoplasias Litoral | Itajaí | Santa Catarina | 88301-220 | Brazil |
| Faculdade de Medicina do ABC - FMABC | Santo André | São Paulo | 09060-650 | Brazil |
| Hospital Perola Byington | São Paulo | São Paulo | 01317-000 | Brazil |
| Instituto Nacional de Cancer - INCa | Rio de Janeiro | 20560-120 | Brazil |
| Complex Oncology Center - Plovdiv First Internal Chemotherapy Department | Plovdiv | 4004 | Bulgaria |
| SHATO - Sofia | Sofia | 1756 | Bulgaria |
| BC Cancer ? Kelowna (Sindi Ahluwalia Hawkins Centre) | Kelowna | British Columbia | V1Y 5L3 | Canada |
| Ottawa Regional Cancer Centre | Ottawa | Ontario | K1Y 4K7 | Canada |
| Saskatoon Cancer Centre | Saskatoon | Saskatchewan | SK S7N 4H4 | Canada |
| CHU de Québec ? Hôpital du Saint-Sacrement / ONCOLOGY | Québec | G1S 4L8 | Canada |
| Fundacion Arturo Lopez Perez | Santiago | 7500921 | Chile |
| The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA) | Beijing | 100071 | China |
| Beijing Cancer Hospital | Beijing | 100142 | China |
| the First Hospital of Jilin University | Changchun | 130021 | China |
| Sun Yet-sen University Cancer Center | Guangzhou | 510060 | China |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | 510120 | China |
| Zhejiang Provincial People's Hospital | Hangzhou | 310014 | China |
| Zhejiang Cancer Hospital | Hangzhou | 310022 | China |
| Harbin Medical University Cancer Hospital | Harbin | 150081 | China |
| Jiangsu Cancer Hospital | Nanjing | 211100 | China |
| Fudan University Shanghai Cancer Center | Shanghai | 200120 | China |
| Fakultni nemocnice Olomouc | Olomouc | 775 20 | Czechia |
| Fakultni Poliklinika Vseobecne Fakultni Niemocnice | Prague | 128 08 | Czechia |
| Odense Universitetshospital, Onkologisk Afdeling R | Odense | 5000 | Denmark |
| Vejle Sygehus | Vejle | 7100 | Denmark |
| Centre Francois Baclesse | Caen | 14076 | France |
| Centre Georges Francois Leclerc | Dijon | 21079 | France |
| Institut Paoli Calmettes | Marseille | 13273 | France |
| Institut régional du Cancer Montpellier | Montpellier | 34298 | France |
| Hopital Tenon | Paris | 75020 | France |
| Institut Curie | Paris | 75231 | France |
| Institut Curie - Hopital Rene Huguenin | Saint-Cloud | 92211 | France |
| Ico Rene Gauducheau | Saint-Herblain | 44805 | France |
| Studienzentrum Aschaffenburg | Aschaffenburg | 63739 | Germany |
| Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche | Berlin | 12163 | Germany |
| HELIOS Klinikum Berlin-Buch | Berlin | 13125 | Germany |
| Rotkreuzklinikum München | München | 80637 | Germany |
| Klinikum der Universität München | München | 81377 | Germany |
| Grupo Angeles | Guatemala City | 01015 | Guatemala |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| Szent Margit Hospital | Budapest | 1031 | Hungary |
| Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika | Debrecen | 4032 | Hungary |
| Markusovszky Hospital | Szombathely | 9700 | Hungary |
| Shaare Zedek Medical Center | Jerusalem | 91031 | Israel |
| Tel Aviv Sourasky Medical Ctr | Tel Aviv | 6423906 | Israel |
| Ospedale San Carlo | Potenza | Basilicate | 85100 | Italy |
| Campus Universitario S.Venuta | Catanzaro | Calabria | 88100 | Italy |
| Istituto Nazionale Tumori Irccs Fondazione g. PASCALE | Naples | Campania | 80131 | Italy |
| IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola | Meldola | Emilia-Romagna | 47014 | Italy |
| Ospedale Regionale Di Parma | Parma | Emilia-Romagna | 43100 | Italy |
| RCCS - Centro di Riferimento | Aviano (PN) | Friuli Venezia Giulia | 33081 | Italy |
| Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia | Udine | Friuli Venezia Giulia | 33100 | Italy |
| Irccs Istituto Nazionale Dei Tumori (Int) | Milan | Lombardy | 20133 | Italy |
| Istituto Europeo Di Oncologia | Milan | Lombardy | 20141 | Italy |
| Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo | Candiolo | Piedmont | 10060 | Italy |
| Ospedale Civile | Sassari | Sardinia | 07100 | Italy |
| Humanitas Istituto Clinico Catanese S.p.A | Misterbianco (CT) | Sicily | 95045 | Italy |
| Hiroshima University Hospital | Hiroshima | 734-8551 | Japan |
| Hyogo Cancer Center | Hyōgo | 673-8558 | Japan |
| Centro de Investigacion | Acapulco de Juárez | Guerrero | 39670 | Mexico |
| Instituto Nacional de Cancer | D.F. | Mexico CITY (federal District) | 14080 | Mexico |
| Consultorio de Medicina Especializada | Distrito Federal | 03100 | Mexico |
| Auckland city hospital | Auckland | 1023 | New Zealand |
| Private Health Organization Acibadem Sistina Hospital | Skopje | 1000 | North Macedonia |
| Oslo Universitetssykehus HF | Oslo | 0310 | Norway |
| The Panama Clinic | Panama City | 0832 | Panama |
| Instituto Nacional de Enfermedades Neoplasicas | Lima | 15038 | Peru |
| Instituto | Lima | 18 | Peru |
| Cebu Cancer Institute | Cebu City | 6000 | Philippines |
| Veterans Memorial Medical Ctr | Quezon City | 1101 | Philippines |
| Cardinal Santos Medical Center | San Juan City | 1502 | Philippines |
| Uniwersyteckie Centrum Kliniczne | Gdansk | 80-952 | Poland |
| ?wi?tokrzyskie Centrum Onkologii | Kielce | 25-734 | Poland |
| Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii | Otwock | 05-400 | Poland |
| Wielkopolskie Centrum Onkologii | Poznan | 61-866 | Poland |
| Wojewódzki Szpital Specjalistyczny Nr 3 | Rybnik | 44-200 | Poland |
| Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie | Warsaw | 02-781 | Poland |
| Hospital da Luz | Lisbon | 1500-650 | Portugal |
| Centro Hospitalar do Porto ? Hospital de Santo António | Porto | 4099-001 | Portugal |
| IPO do Porto | Porto | 4200-072 | Portugal |
| Bashkirian Republican Clinical Oncology Dispensary | Ufa | Bashkortostan Republic | 450054 | Russia |
| SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan | Ufa | Bashkortostan Republic | 450054 | Russia |
| City Clinical Oncology Hospital | Moscow | Moscow Oblast | 143423 | Russia |
| Blokhin Cancer Research Center | Moskva | Moscow Oblast | 115478 | Russia |
| FSBI?National Medical Research Center of Oncology named after N.N.Petrov? MHRF | Saint Petersburg | Sankt-Peterburg | 197758 | Russia |
| City Oncology Dispensary | Saint Petersburg | Sankt-Peterburg | Russia |
| SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary | Stavropol | 355045 | Russia |
| Institute of Oncology Ljubljana | Ljubljana | 1000 | Slovenia |
| Kyungpook National University Medical Center | Daegu | 702-210 | South Korea |
| National Cancer Center | Gyeonggi-do | 10408 | South Korea |
| Gachon University Gil Medical Center | Incheon | 21565 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Seoul National University Hospital | Seoul | 110744 | South Korea |
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| Hospital General Universitario de Elche | Elche | Alicante | 03203 | Spain |
| Hospital de Jerez de la Frontera | Jerez de la Frontera | Cadiz | 11407 | Spain |
| Hospital de Donostia | Donostia / San Sebastian | Guipuzcoa | 20080 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Vall d'Hebron Institute of Oncology (VHIO), Barcelona | Barcelona | 08035 | Spain |
| Hospital Duran i Reynals | Barcelona | 08907 | Spain |
| Hospital San Pedro De Alcantara | Cáceres | 10003 | Spain |
| Hospital Universitari Arnau de Vilanova de Lleida | Lleida | 25198 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | 28007 | Spain |
| Hospital Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |
| Universitätsspital Zürich | Zurich | 8091 | Switzerland |
| Chi-Mei Medical Center | Tainan | 736 | Taiwan |
| National Taiwan Uni Hospital | Taipei | 100 | Taiwan |
| Bumrungrad International Hosp | Bangkok | 10110 | Thailand |
| Rajavithi Hospital | Bangkok | 10400 | Thailand |
| Ninewells Hospital | Dundee | DD12 9SY | United Kingdom |
| Western General Hospital | Edinburgh | EH4 2XU | United Kingdom |
| Diana Princess of Wales Hosp. | Grimsby | DN33 2BA | United Kingdom |
| Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust | Lancaster | LA1 4RP | United Kingdom |
| Royal Free Hospital | London | NW3 2QG | United Kingdom |
| Christie Hospital NHS Trust | Manchester | M20 4BX | United Kingdom |
| Mount Vernon Hospital | Middlesex | HA6 2RN | United Kingdom |
| Nottingham City Hospital | Nottingham | NG5 1PB | United Kingdom |
| Poole General Hospital | Poole | BH15 2JB | United Kingdom |
| Queen's Hospital | Romford | RM7 0AG | United Kingdom |
| Abertawe and Bro Morgannwg NHS Trust | Swansea | SA6 6NL | United Kingdom |
| Royal Cornwall Hospital | Truro | TR1 3LJ | United Kingdom |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D017239 | Paclitaxel |
| C485206 | pertuzumab |
| D000068878 | Trastuzumab |
| D000080044 | Ado-Trastuzumab Emtansine |
| C000594389 | atezolizumab |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D008453 | Maytansine |
| D018942 | Macrolides |
| D007783 | Lactones |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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