Neoplasm MetastasisPhase 2NCT00781612
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
A Phase 2 study testing Docetaxel, Paclitaxel and Pertuzumab in people with Neoplasm Metastasis, run by Genentech, Inc. at 179 sites in 35 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Metastasis
- What is being tested?
- Docetaxel, Paclitaxel and Pertuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 378 participants
- Where
- 179 sitesin 35 countries
- Study dates
- 16 Oct 2008to 30 Jun 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
179 sites in 35 countries.
179 sites in 35 countries
United States49 sites
Anne Arundel Medical Center
Annapolis, Maryland, 21401
Univ of Colorado Canc Ctr
Aurora, Colorado, 80045
University of Colorado
Aurora, Colorado, 80045
Johns Hopkins Univ Med Center
Baltimore, Maryland, 21231-1000
Texas Oncology
Bedford, Texas, 76022
Hematology-Oncology
Bettendorf, Iowa, 52722
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Oncology Assoc of Cedar Rapids
Cedar Rapids, Iowa, 52403
Sarah Cannon Research Institute / Tennessee Oncology
Chattanooga, Tennessee, 37404
The Mark H. Zangmeister Ctr
Columbus, Ohio, 43219
Texas Oncology - Dallas Presbyterian Hospital
Dallas, Texas, 75231
Rocky Mountain Cancer Center - Denver
Denver, Colorado, 80220
Karmanos Cancer Institute
Detroit, Michigan, 48201
City of Hope National Medical Center
Duarte, California, 91010
Florida Cancer Specialists
Fort Myers, Florida, 33916
Carolina Oncology Specialists, PA - Hickory
Hickory, North Carolina, 28602
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Clinical Research Alliance
Lake Success, New York, 11042
NS-Long Island Jewish Hlth Sys
Lake Success, New York, 11042
Comp Cancer Centers of Nevada
Las Vegas, Nevada, 89148
St. Barnabas Health Care Sys
Livingston, New Jersey, 07039
Northwest Georgia Oncology Centers PC - Marietta
Marietta, Georgia, 30060
Loyola University Med Center
Maywood, Illinois, 60153
Minnesota Oncology Hematology, Pa
Minneapolis, Minnesota, 55407
University of Minnesota.
Minneapolis, Minnesota, 55455
Sarah Cannon Research Institute / Tennessee Oncology
Nashville, Tennessee, 37203
Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
New York, New York, 10016
Christina Care Institutional Review Board
Newark, Delaware, 19713
Memorial Cancer Institute at Memorial West
Pembroke Pines, Florida, 33028
Illinois Cancer Care
Peoria, Illinois, 61615
USO
Plano, Texas, 75075-7787
Northwest Cancer Specialists - Portland (N Broadway)
Portland, Oregon, 97227
Kootenai Cancer Center
Post Falls, Idaho, 83854
Can Care Assoc Med Group Inc
Redondo Beach, California, 90277
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Cancer Therapy & Research Center
San Antonio, Texas, 78229
Univ of Calif, San Francisco
San Francisco, California, 94115
Central Coast Medical Oncology
San Luis Obispo, California, 93454
UCLA Oncology Office
Santa Monica, California, 90404
Uni of Washington Medical Center
Seattle, Washington, 98109-1023
Univ of WA Medical Center
Seattle, Washington, 98109
Mercy Clinic Cancer & Hematology
Springfield, Missouri, 65804
St. John's Mercy Medical Ctr
St Louis, Missouri, 63141
Florida Cancer Specialists (St. Petersburg ? St. Anthony?s Professional Building)
St. Petersburg, Florida, 33705
Stanford Cancer Institute
Stanford, California, 94305-5456
Northwest Medical Specialties
Tacoma, Washington, 98405
Florida Cancer Specialists - Tampa (Dr. MLK Blvd)
Tampa, Florida, 33607
USO - Tyler Cancer Ctr
Tyler, Texas, 75702
Kaiser Permanente - Walnut Creek
Walnut Creek, California, 94596
Italy12 sites
RCCS - Centro di Riferimento
Aviano (PN), Friuli Venezia Giulia, 33081
Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo
Candiolo, Piedmont, 10060
Campus Universitario S.Venuta
Catanzaro, Calabria, 88100
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
Meldola, Emilia-Romagna, 47014
Irccs Istituto Nazionale Dei Tumori (Int)
Milan, Lombardy, 20133
Istituto Europeo Di Oncologia
Milan, Lombardy, 20141
Humanitas Istituto Clinico Catanese S.p.A
Misterbianco (CT), Sicily, 95045
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE
Naples, Campania, 80131
Ospedale Regionale Di Parma
Parma, Emilia-Romagna, 43100
Ospedale San Carlo
Potenza, Basilicate, 85100
Ospedale Civile
Sassari, Sardinia, 07100
Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia
Udine, Friuli Venezia Giulia, 33100
United Kingdom12 sites
Ninewells Hospital
Dundee, DD12 9SY
Western General Hospital
Edinburgh, EH4 2XU
Diana Princess of Wales Hosp.
Grimsby, DN33 2BA
Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust
Lancaster, LA1 4RP
Royal Free Hospital
London, NW3 2QG
Christie Hospital NHS Trust
Manchester, M20 4BX
Mount Vernon Hospital
Middlesex, HA6 2RN
Nottingham City Hospital
Nottingham, NG5 1PB
Poole General Hospital
Poole, BH15 2JB
Queen's Hospital
Romford, RM7 0AG
Abertawe and Bro Morgannwg NHS Trust
Swansea, SA6 6NL
Royal Cornwall Hospital
Truro, TR1 3LJ
China11 sites
The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
Beijing, 100071
Beijing Cancer Hospital
Beijing, 100142
the First Hospital of Jilin University
Changchun, 130021
Sun Yet-sen University Cancer Center
Guangzhou, 510060
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, 510120
Zhejiang Provincial People's Hospital
Hangzhou, 310014
Zhejiang Cancer Hospital
Hangzhou, 310022
Harbin Medical University Cancer Hospital
Harbin, 150081
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
Nanjing, 210029
Jiangsu Cancer Hospital
Nanjing, 211100
Fudan University Shanghai Cancer Center
Shanghai, 200120
Spain11 sites
Hospital del Mar
Barcelona, 08003
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, 08035
Hospital Duran i Reynals
Barcelona, 08907
Hospital San Pedro De Alcantara
Cáceres, 10003
Hospital de Donostia
Donostia / San Sebastian, Guipuzcoa, 20080
Hospital General Universitario de Elche
Elche, Alicante, 03203
Hospital de Jerez de la Frontera
Jerez de la Frontera, Cadiz, 11407
Hospital Universitari Arnau de Vilanova de Lleida
Lleida, 25198
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Hospital Ramon y Cajal
Madrid, 28034
Hospital Universitario Miguel Servet
Zaragoza, 50009
France8 sites
Centre Francois Baclesse
Caen, 14076
Centre Georges Francois Leclerc
Dijon, 21079
Institut Paoli Calmettes
Marseille, 13273
Institut régional du Cancer Montpellier
Montpellier, 34298
Hopital Tenon
Paris, 75020
Institut Curie
Paris, 75231
Institut Curie - Hopital Rene Huguenin
Saint-Cloud, 92211
Ico Rene Gauducheau
Saint-Herblain, 44805
Russia7 sites
City Clinical Oncology Hospital
Moscow, Moscow Oblast, 143423
Blokhin Cancer Research Center
Moskva, Moscow Oblast, 115478
FSBI?National Medical Research Center of Oncology named after N.N.Petrov? MHRF
Saint Petersburg, Sankt-Peterburg, 197758
City Oncology Dispensary
Saint Petersburg, Sankt-Peterburg
SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary
Stavropol, 355045
Bashkirian Republican Clinical Oncology Dispensary
Ufa, Bashkortostan Republic, 450054
SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan
Ufa, Bashkortostan Republic, 450054
South Korea7 sites
Kyungpook National University Medical Center
Daegu, 702-210
National Cancer Center
Gyeonggi-do, 10408
Gachon University Gil Medical Center
Incheon, 21565
Severance Hospital, Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Seoul National University Hospital
Seoul, 110744
Samsung Medical Center
Seoul, 135-710
Brazil6 sites
Clinica de Neoplasias Litoral
Itajaí, Santa Catarina, 88301-220
Clinica de Oncologia de Porto Alegre - CliniOnco
Porto Alegre, Rio Grande do Sul, 90430-090
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, 91350-200
Instituto Nacional de Cancer - INCa
Rio de Janeiro, 20560-120
Faculdade de Medicina do ABC - FMABC
Santo André, São Paulo, 09060-650
Hospital Perola Byington
São Paulo, São Paulo, 01317-000
Poland6 sites
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952
?wi?tokrzyskie Centrum Onkologii
Kielce, 25-734
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
Otwock, 05-400
Wielkopolskie Centrum Onkologii
Poznan, 61-866
Wojewódzki Szpital Specjalistyczny Nr 3
Rybnik, 44-200
Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie
Warsaw, 02-781
Germany5 sites
Studienzentrum Aschaffenburg
Aschaffenburg, 63739
Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche
Berlin, 12163
HELIOS Klinikum Berlin-Buch
Berlin, 13125
Rotkreuzklinikum München
München, 80637
Klinikum der Universität München
München, 81377
Canada4 sites
BC Cancer ? Kelowna (Sindi Ahluwalia Hawkins Centre)
Kelowna, British Columbia, V1Y 5L3
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1Y 4K7
CHU de Québec ? Hôpital du Saint-Sacrement / ONCOLOGY
Québec, G1S 4L8
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, SK S7N 4H4
Hungary3 sites
Szent Margit Hospital
Budapest, 1031
Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika
Debrecen, 4032
Markusovszky Hospital
Szombathely, 9700
Mexico3 sites
Centro de Investigacion
Acapulco de Juárez, Guerrero, 39670
Instituto Nacional de Cancer
D.F., Mexico CITY (federal District), 14080
Consultorio de Medicina Especializada
Distrito Federal, 03100
Philippines3 sites
Cebu Cancer Institute
Cebu City, 6000
Veterans Memorial Medical Ctr
Quezon City, 1101
Cardinal Santos Medical Center
San Juan City, 1502
Portugal3 sites
Hospital da Luz
Lisbon, 1500-650
Centro Hospitalar do Porto ? Hospital de Santo António
Porto, 4099-001
IPO do Porto
Porto, 4200-072
Australia2 sites
Peninsula and South Eastern Haematology and Oncology Group
Frankston, Victoria, 3199
Peter MacCallum Cancer Center
Melbourne, Victoria, 3000
Belgium2 sites
UZ Gent
Ghent, 9000
ZAS Sint Augustinus Wilrijk, Pharmacy
Wilrijk, 2610
Bulgaria2 sites
Complex Oncology Center - Plovdiv First Internal Chemotherapy Department
Plovdiv, 4004
SHATO - Sofia
Sofia, 1756
Czechia2 sites
Fakultni nemocnice Olomouc
Olomouc, 775 20
Fakultni Poliklinika Vseobecne Fakultni Niemocnice
Prague, 128 08
Denmark2 sites
Odense Universitetshospital, Onkologisk Afdeling R
Odense, 5000
Vejle Sygehus
Vejle, 7100
Israel2 sites
Shaare Zedek Medical Center
Jerusalem, 91031
Tel Aviv Sourasky Medical Ctr
Tel Aviv, 6423906
Japan2 sites
Hiroshima University Hospital
Hiroshima, 734-8551
Hyogo Cancer Center
Hyōgo, 673-8558
Peru2 sites
Instituto Nacional de Enfermedades Neoplasicas
Lima, 15038
Instituto
Lima, 18
Taiwan2 sites
Chi-Mei Medical Center
Tainan, 736
National Taiwan Uni Hospital
Taipei, 100
Thailand2 sites
Bumrungrad International Hosp
Bangkok, 10110
Rajavithi Hospital
Bangkok, 10400
North Macedonia1 site
Private Health Organization Acibadem Sistina Hospital
Skopje, 1000
About this study
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
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.
- Conditions
- Neoplasm Metastasis
- Being tested
- Docetaxel, Paclitaxel, Pertuzumab, Trastuzumab, Trastuzumab Emtansine
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Docetaxel will be administered as per local prescribing information.
PaclitaxelDrug
Paclitaxel will be administered as per local prescribing information.
PertuzumabDrug
Also called Perjeta
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).
TrastuzumabDrug
Also called Herceptin
Trastuzumab will be administered as per local prescribing information.
Trastuzumab EmtansineDrug
Also called Kadcyla; T-DM1
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).
AtezolizumabDrug
Also called Tecentriq
Atezolizumab will be administered at a dose of 1200 mg by IV infusion every three weeks (Q3W)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Docetaxel; Drug: Paclitaxel; Drug: Pertuzumab; Drug: Trastuzumab; Drug: Trastuzumab Emtansine; Drug: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Baseline up to 30 days after last dose of study drug administration (up to approximately 18 years)
Percentage of Participants With Adverse Events Leading to Study Treatment Discontinuation or Dose Reduction
Measured: Baseline up to 30 days after last dose of study drug administration (up to approximately 18 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2008 (estimated)
- Study start16 Oct 2008
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm MetastasisStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 378 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781612
- Sponsor's protocol ID
- TDM4529g
- Other IDs
- BO25430, 2010-021067-32, 2023-503479-79-00, 2023
- Status last verified
- Aug 2026
- First submitted
- 27 Oct 2008
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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