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
- Conditions
- Neoplasm Metastasis
- Interventions
- Registration Number
- NCT00781612
- Lead Sponsor
- Genentech, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 720
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Trastuzumab Emtansine Pertuzumab 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. Trastuzumab Emtansine Trastuzumab 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. Trastuzumab Emtansine Docetaxel 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. Trastuzumab Emtansine Paclitaxel 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. Trastuzumab Emtansine Trastuzumab Emtansine 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. Trastuzumab Emtansine Atezolizumab 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.
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (178)
Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche
🇩🇪Berlin, Germany
HELIOS Klinikum Berlin-Buch
🇩🇪Berlin, Germany
Rotkreuzklinikum München
🇩🇪Muenchen, Germany
Klinikum der Universität München
🇩🇪Muenchen, Germany
Grupo Angeles
🇬🇹Guatemala City, Guatemala
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong
Szent Margit Hospital
🇭🇺Budapest, Hungary
Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika
🇭🇺Debrecen, Hungary
Markusovszky Hospital
🇭🇺Szombathely, Hungary
Peter MacCallum Cancer Center
🇦🇺Melbourne, Victoria, Australia
UZ Gent
🇧🇪Gent, Belgium
Sint Augustinus Wilrijk, Apotheek
🇧🇪Wilrijk, Belgium
Clinica de Oncologia de Porto Alegre - CliniOnco
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Institut Curie - Hopital Rene Huguenin
🇫🇷Saint-Cloud, France
Studienzentrum Aschaffenburg
🇩🇪Aschaffenburg, Germany
Institut Curie
🇫🇷Paris, France
Ico Rene Gauducheau
🇫🇷Saint Herblain, France
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangzhou City, China
Sun Yet-sen University Cancer Center
🇨🇳Guangzhou, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, China
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
🇨🇳Nanjing City, China
Jiangsu Cancer Hospital
🇨🇳Nanjing City, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai City, China
Fakultni nemocnice Olomouc
🇨🇿Olomouc, Czechia
Fakultni Poliklinika Vseobecne Fakultni Niemocnice
🇨🇿Praha 2, Czechia
Odense Universitetshospital, Onkologisk Afdeling R
🇩🇰Odense, Denmark
Vejle Sygehus
🇩🇰Vejle, Denmark
Centre Francois Baclesse
🇫🇷Caen, France
Centre Georges Francois Leclerc
🇫🇷Dijon, France
Institut Paoli Calmettes
🇫🇷Marseille, France
Institut régional du Cancer Montpellier
🇫🇷Montpellier, France
Hopital Tenon
🇫🇷Paris, France
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Tel Aviv Sourasky Medical Ctr
🇮🇱Tel Aviv, Israel
Ospedale San Carlo
🇮🇹Potenza, Basilicata, Italy
Campus Universitario S.Venuta
🇮🇹Catanzaro, Calabria, Italy
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE
🇮🇹Napoli, Campania, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
🇮🇹Meldola, Emilia-Romagna, Italy
Ospedale Regionale Di Parma
🇮🇹Parma, Emilia-Romagna, Italy
RCCS - Centro di Riferimento
🇮🇹Aviano (PN), Friuli-Venezia Giulia, Italy
Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia
🇮🇹Udine, Friuli-Venezia Giulia, Italy
Irccs Istituto Nazionale Dei Tumori (Int)
🇮🇹Milano, Lombardia, Italy
Istituto Europeo Di Oncologia
🇮🇹Milano, Lombardia, Italy
Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo
🇮🇹Candiolo, Piemonte, Italy
Ospedale Civile
🇮🇹Sassari, Sardegna, Italy
Humanitas Istituto Clinico Catanese S.p.A
🇮🇹Misterbianco (CT), Sicilia, Italy
Hiroshima University Hospital
🇯🇵Hiroshima, Japan
Hyogo Cancer Center
🇯🇵Hyogo, Japan
Kyungpook National University Medical Center
🇰🇷Daegu, Korea, Republic of
National Cancer Center
🇰🇷Gyeonggi-do, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Centro de Investigacion
🇲🇽Acapulco, Guerrero, Mexico
Instituto Nacional de Cancer
🇲🇽D.f., Mexico CITY (federal District), Mexico
Consultorio de Medicina Especializada
🇲🇽Distrito Federal, Mexico
Auckland city hospital
🇳🇿Auckland, New Zealand
Private Health Organization Acibadem Sistina Hospital
🇲🇰Skopje, North Macedonia
Oslo Universitetssykehus HF
🇳🇴Oslo, Norway
The Panama Clinic
🇵🇦Panama City, Panama
Instituto Nacional de Enfermedades Neoplasicas
🇵🇪Lima, Peru
Instituto
🇵🇪Lima, Peru
Cebu Cancer Institute
🇵🇭Cebu City, Philippines
Veterans Memorial Medical Ctr
🇵🇭Quezon City, Philippines
Cardinal Santos Medical Center
🇵🇭San Juan, Philippines
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdansk, Poland
?wi?tokrzyskie Centrum Onkologii
🇵🇱Kielce, Poland
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
🇵🇱Otwock, Poland
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Wielkopolskie Centrum Onkologii
🇵🇱Poznan, Poland
Wojewódzki Szpital Specjalistyczny Nr 3
🇵🇱Rybnik, Poland
Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie
🇵🇱Warszawa, Poland
Universitätsspital Zürich
🇨🇭Zürich, Switzerland
Hospital da Luz
🇵🇹Lisboa, Portugal
Bashkirian Republican Clinical Oncology Dispensary
🇷🇺UFA, Baskortostan, Russian Federation
SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan
🇷🇺Ufa, Baskortostan, Russian Federation
City Clinical Oncology Hospital
🇷🇺Moscow, Moskovskaja Oblast, Russian Federation
Blokhin Cancer Research Center
🇷🇺Moskva, Moskovskaja Oblast, Russian Federation
Chi-Mei Medical Center
🇨🇳Tainan, Taiwan
FSBI?National Medical Research Center of Oncology named after N.N.Petrov? MHRF
🇷🇺ST Petersburg, Sankt Petersburg, Russian Federation
City Oncology Dispensary
🇷🇺St Petersburg, Sankt Petersburg, Russian Federation
SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary
🇷🇺Stavropol, Russian Federation
National Taiwan Uni Hospital
🇨🇳Taipei, Taiwan
Institute of Oncology Ljubljana
🇸🇮Ljubljana, Slovenia
Hospital General Universitario de Elche
🇪🇸Elche, Alicante, Spain
Hospital de Jerez de la Frontera
🇪🇸Jerez de La Frontera, Cadiz, Spain
Hospital de Donostia
🇪🇸San Sebastian, Guipuzcoa, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
🇪🇸Barcelona, Spain
Hospital Duran i Reynals
🇪🇸Barcelona, Spain
Hospital San Pedro De Alcantara
🇪🇸Caceres, Spain
Hospital Universitari Arnau de Vilanova de Lleida
🇪🇸Lerida, Spain
Hospital General Universitario Gregorio Marañon
🇪🇸Madrid, Spain
Hospital Ramon y Cajal
🇪🇸Madrid, Spain
Bumrungrad International Hosp
🇹🇭Bangkok, Thailand
Rajavithi Hospital
🇹🇭Bangkok, Thailand
Ninewells Hospital
🇬🇧Dundee, United Kingdom
Western General Hospital
🇬🇧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
🇬🇧London, United Kingdom
Christie Hospital NHS Trust
🇬🇧Manchester, United Kingdom
Mount Vernon Hospital
🇬🇧Middlesex, United Kingdom
Nottingham City Hospital
🇬🇧Nottingham, United Kingdom
Poole General Hospital
🇬🇧Poole, United Kingdom
Queen's Hospital
🇬🇧Romford, United Kingdom
Abertawe and Bro Morgannwg NHS Trust
🇬🇧Swansea, United Kingdom
Royal Cornwall Hospital
🇬🇧Truro, United Kingdom
Sarah Cannon Research Institute / Tennessee Oncology
🇺🇸Nashville, Tennessee, United States
Texas Oncology
🇺🇸Bedford, Texas, United States
Texas Oncology - Dallas Presbyterian Hospital
🇺🇸Dallas, Texas, United States
USO
🇺🇸Plano, Texas, United States
Cancer Therapy & Research Center
🇺🇸San Antonio, Texas, United States
USO - Tyler Cancer Ctr
🇺🇸Tyler, Texas, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States
Can Care Assoc Med Group Inc
🇺🇸Redondo Beach, California, United States
Univ of Calif, San Francisco
🇺🇸San Francisco, California, United States
Central Coast Medical Oncology
🇺🇸San Luis Obispo, California, United States
Uni of Washington Medical Center
🇺🇸Seattle, Washington, United States
Univ of WA Medical Center
🇺🇸Seattle, Washington, United States
Northwest Medical Specialties
🇺🇸Tacoma, Washington, United States
Peninsula and South Eastern Haematology and Oncology Group
🇦🇺Frankston, Victoria, Australia
Hospital Nossa Senhora da Conceicao
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
UCLA Oncology Office
🇺🇸Santa Monica, California, United States
Stanford Cancer Institute
🇺🇸Stanford, California, United States
Kaiser Permanente - Walnut Creek
🇺🇸Walnut Creek, California, United States
Univ of Colorado Canc Ctr
🇺🇸Aurora, Colorado, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Rocky Mountain Cancer Center - Denver
🇺🇸Denver, Colorado, United States
Clinica de Neoplasias Litoral
🇧🇷Itajai, Santa Catarina, Brazil
Faculdade de Medicina do ABC - FMABC
🇧🇷Santo Andre, São Paulo, Brazil
Hospital Perola Byington
🇧🇷Sao Paulo, São Paulo, Brazil
Instituto Nacional de Cancer - INCa
🇧🇷Rio de Janeiro, Brazil
Complex Oncology Center - Plovdiv First Internal Chemotherapy Department
🇧🇬Plovdiv, Bulgaria
SHATO - Sofia
🇧🇬Sofia, Bulgaria
BC Cancer ? Kelowna (Sindi Ahluwalia Hawkins Centre)
🇨🇦Kelowna, British Columbia, Canada
Ottawa Regional Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
CHU de Québec ? Hôpital du Saint-Sacrement / ONCOLOGY
🇨🇦Quebec, Canada
Fundacion Arturo Lopez Perez
🇨🇱Santiago, Chile
The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
🇨🇳Beijing, China
Beijing Cancer Hospital
🇨🇳Beijing, China
the First Hospital of Jilin University
🇨🇳Changchun, China
Christina Care Institutional Review Board
🇺🇸Newark, Delaware, United States
Florida Cancer Specialists
🇺🇸Fort Myers, Florida, United States
Memorial Cancer Institute at Memorial West
🇺🇸Pembroke Pines, Florida, United States
Florida Cancer Specialists (St. Petersburg ? St. Anthony?s Professional Building)
🇺🇸Saint Petersburg, Florida, United States
Florida Cancer Specialists - Tampa (Dr. MLK Blvd)
🇺🇸Tampa, Florida, United States
Northwest Georgia Oncology Centers PC - Marietta
🇺🇸Marietta, Georgia, United States
Kootenai Cancer Center
🇺🇸Post Falls, Idaho, United States
Loyola University Med Center
🇺🇸Maywood, Illinois, United States
Illinois Cancer Care
🇺🇸Peoria, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Hematology-Oncology
🇺🇸Bettendorf, Iowa, United States
Oncology Assoc of Cedar Rapids
🇺🇸Cedar Rapids, Iowa, United States
Anne Arundel Medical Center
🇺🇸Annapolis, Maryland, United States
Johns Hopkins Univ Med Center
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Minnesota Oncology Hematology, Pa
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota.
🇺🇸Minneapolis, Minnesota, United States
Mayo Clinic - Rochester
🇺🇸Rochester, Minnesota, United States
St. John's Mercy Medical Ctr
🇺🇸Saint Louis, Missouri, United States
Mercy Clinic Cancer & Hematology
🇺🇸Springfield, Missouri, United States
Comp Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
St. Barnabas Health Care Sys
🇺🇸Livingston, New Jersey, United States
Clinical Research Alliance
🇺🇸Lake Success, New York, United States
NS-Long Island Jewish Hlth Sys
🇺🇸Lake Success, New York, 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
Carolina Oncology Specialists, PA - Hickory
🇺🇸Hickory, North Carolina, United States
The Mark H. Zangmeister Ctr
🇺🇸Columbus, Ohio, United States
Northwest Cancer Specialists - Portland (N Broadway)
🇺🇸Portland, Oregon, United States