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
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
4 other identifiers
interventional
720
34 countries
177
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2008
Longer than P75 for phase_2
177 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 16, 2008
CompletedFirst Submitted
Initial submission to the registry
October 27, 2008
CompletedFirst Posted
Study publicly available on registry
October 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2030
December 24, 2025
December 1, 2025
21 years
October 27, 2008
December 23, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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)
Study Arms (1)
Trastuzumab Emtansine
EXPERIMENTALParticipants 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.
Interventions
Docetaxel will be administered as per local prescribing information.
Paclitaxel will be administered as per local prescribing information.
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 will be administered as per local prescribing information.
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 will be administered at a dose of 1200 mg by IV infusion every three weeks (Q3W)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
- Hoffmann-La Rochecollaborator
Study Sites (178)
City of Hope National Medical Center
Duarte, California, 91010, United States
Can Care Assoc Med Group Inc
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Genentech, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2008
First Posted
October 29, 2008
Study Start
October 16, 2008
Primary Completion (Estimated)
September 30, 2029
Study Completion (Estimated)
April 30, 2030
Last Updated
December 24, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
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