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Cancer drug kadcyla gets extended safety check in 720 patients

NCT ID NCT00781612

Disease control Sponsor: Genentech, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This study offers continued treatment with trastuzumab emtansine (Kadcyla), alone or with other drugs, to 720 patients with metastatic cancer who were already benefiting from it in a previous trial. The main goal is to monitor long-term safety and side effects. It is an open-label extension, meaning everyone knows what they are getting, and no new patients are being enrolled.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
trastuzumab emtansine (Kadcyla), with possible addition of docetaxel, paclitaxel, pertuzumab, or trastuzumab
What this could lead to
If successful, this study could confirm the long-term safety and benefit of trastuzumab emtansine for controlling metastatic cancer.
What could go wrong
This is an extension study, not a new test of effectiveness. Side effects may still occur, and the drug may not work for everyone long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

378 people

The number who actually took part.

Started

Oct 2008

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

metastatic neoplasm Neoplasm Metastasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neoplasm metastasis

Contacts and locations

Locations

  • ?wi?tokrzyskie Centrum Onkologii

    Kielce, 25-734, Poland

  • Abertawe and Bro Morgannwg NHS Trust

    Swansea, SA6 6NL, United Kingdom

  • Anne Arundel Medical Center

    Annapolis, Maryland, 21401, United States

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Auckland city hospital

    Auckland, 1023, New Zealand

  • Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia

    Udine, Friuli Venezia Giulia, 33100, Italy

  • BC Cancer ? Kelowna (Sindi Ahluwalia Hawkins Centre)

    Kelowna, British Columbia, V1Y 5L3, Canada

  • Bashkirian Republican Clinical Oncology Dispensary

    Ufa, Bashkortostan Republic, 450054, Russia

  • Beijing Cancer Hospital

    Beijing, 100142, China

  • Blokhin Cancer Research Center

    Moskva, Moscow Oblast, 115478, Russia

  • Bumrungrad International Hosp

    Bangkok, 10110, Thailand

  • CHU de Québec ? Hôpital du Saint-Sacrement / ONCOLOGY

    Québec, G1S 4L8, Canada

  • Campus Universitario S.Venuta

    Catanzaro, Calabria, 88100, Italy

  • Can Care Assoc Med Group Inc

    Redondo Beach, California, 90277, United States

  • Cancer Therapy & Research Center

    San Antonio, Texas, 78229, United States

  • Cardinal Santos Medical Center

    San Juan City, 1502, Philippines

  • Carolina Oncology Specialists, PA - Hickory

    Hickory, North Carolina, 28602, United States

  • Cebu Cancer Institute

    Cebu City, 6000, Philippines

  • Central Coast Medical Oncology

    San Luis Obispo, California, 93454, United States

  • Centre Francois Baclesse

    Caen, 14076, France

  • Centre Georges Francois Leclerc

    Dijon, 21079, France

  • Centro Hospitalar do Porto ? Hospital de Santo António

    Porto, 4099-001, Portugal

  • Centro de Investigacion

    Acapulco de Juárez, Guerrero, 39670, Mexico

  • Chi-Mei Medical Center

    Tainan, 736, Taiwan

  • Christie Hospital NHS Trust

    Manchester, M20 4BX, United Kingdom

  • Christina Care Institutional Review Board

    Newark, Delaware, 19713, United States

  • City Clinical Oncology Hospital

    Moscow, Moscow Oblast, 143423, Russia

  • City Oncology Dispensary

    Saint Petersburg, Sankt-Peterburg, Russia

  • City of Hope National Medical Center

    Duarte, California, 91010, United States

  • Clinica de Neoplasias Litoral

    Itajaí, Santa Catarina, 88301-220, Brazil

  • Clinica de Oncologia de Porto Alegre - CliniOnco

    Porto Alegre, Rio Grande do Sul, 90430-090, Brazil

  • Clinical Research Alliance

    Lake Success, New York, 11042, United States

  • Comp Cancer Centers of Nevada

    Las Vegas, Nevada, 89148, United States

  • Complex Oncology Center - Plovdiv First Internal Chemotherapy Department

    Plovdiv, 4004, Bulgaria

  • Consultorio de Medicina Especializada

    Distrito Federal, 03100, Mexico

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

  • Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika

    Debrecen, 4032, Hungary

  • Diana Princess of Wales Hosp.

    Grimsby, DN33 2BA, United Kingdom

  • Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii

    Otwock, 05-400, Poland

  • FSBI?National Medical Research Center of Oncology named after N.N.Petrov? MHRF

    Saint Petersburg, Sankt-Peterburg, 197758, Russia

  • Faculdade de Medicina do ABC - FMABC

    Santo André, São Paulo, 09060-650, Brazil

  • Fakultni Poliklinika Vseobecne Fakultni Niemocnice

    Prague, 128 08, Czechia

  • Fakultni nemocnice Olomouc

    Olomouc, 775 20, Czechia

  • Florida Cancer Specialists

    Fort Myers, Florida, 33916, 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

  • Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo

    Candiolo, Piedmont, 10060, Italy

  • Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche

    Berlin, 12163, Germany

  • Fudan University Shanghai Cancer Center

    Shanghai, 200120, China

  • Fundacion Arturo Lopez Perez

    Santiago, 7500921, Chile

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • Grupo Angeles

    Guatemala City, 01015, Guatemala

  • HELIOS Klinikum Berlin-Buch

    Berlin, 13125, Germany

  • Harbin Medical University Cancer Hospital

    Harbin, 150081, China

  • Hematology-Oncology

    Bettendorf, Iowa, 52722, United States

  • Hiroshima University Hospital

    Hiroshima, 734-8551, Japan

  • Hopital Tenon

    Paris, 75020, France

  • Hospital Duran i Reynals

    Barcelona, 08907, Spain

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007, Spain

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203, Spain

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

  • Hospital Perola Byington

    São Paulo, São Paulo, 01317-000, Brazil

  • Hospital Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital San Pedro De Alcantara

    Cáceres, 10003, Spain

  • Hospital Universitari Arnau de Vilanova de Lleida

    Lleida, 25198, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital da Luz

    Lisbon, 1500-650, Portugal

  • Hospital de Donostia

    Donostia / San Sebastian, Guipuzcoa, 20080, Spain

  • Hospital de Jerez de la Frontera

    Jerez de la Frontera, Cadiz, 11407, Spain

  • Hospital del Mar

    Barcelona, 08003, Spain

  • Humanitas Istituto Clinico Catanese S.p.A

    Misterbianco (CT), Sicily, 95045, Italy

  • Hyogo Cancer Center

    Hyōgo, 673-8558, Japan

  • IPO do Porto

    Porto, 4200-072, Portugal

  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola

    Meldola, Emilia-Romagna, 47014, Italy

  • Ico Rene Gauducheau

    Saint-Herblain, 44805, France

  • Illinois Cancer Care

    Peoria, Illinois, 61615, United States

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202, United States

  • Institut Curie

    Paris, 75231, France

  • Institut Curie - Hopital Rene Huguenin

    Saint-Cloud, 92211, France

  • Institut Paoli Calmettes

    Marseille, 13273, France

  • Institut régional du Cancer Montpellier

    Montpellier, 34298, France

  • Institute of Oncology Ljubljana

    Ljubljana, 1000, Slovenia

  • Instituto

    Lima, 18, Peru

  • Instituto Nacional de Cancer

    D.F., Mexico CITY (federal District), 14080, Mexico

  • Instituto Nacional de Cancer - INCa

    Rio de Janeiro, 20560-120, Brazil

  • Instituto Nacional de Enfermedades Neoplasicas

    Lima, 15038, Peru

  • Irccs Istituto Nazionale Dei Tumori (Int)

    Milan, Lombardy, 20133, Italy

  • Istituto Europeo Di Oncologia

    Milan, Lombardy, 20141, Italy

  • Istituto Nazionale Tumori Irccs Fondazione g. PASCALE

    Naples, Campania, 80131, Italy

  • Jiangsu Cancer Hospital

    Nanjing, 211100, China

  • Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

    Nanjing, 210029, China

  • Johns Hopkins Univ Med Center

    Baltimore, Maryland, 21231-1000, United States

  • Kaiser Permanente - Walnut Creek

    Walnut Creek, California, 94596, United States

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Klinikum der Universität München

    München, 81377, Germany

  • Kootenai Cancer Center

    Post Falls, Idaho, 83854, United States

  • Kyungpook National University Medical Center

    Daegu, 702-210, South Korea

  • Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

    New York, New York, 10016, United States

  • Loyola University Med Center

    Maywood, Illinois, 60153, United States

  • Markusovszky Hospital

    Szombathely, 9700, Hungary

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905, United States

  • Memorial Cancer Institute at Memorial West

    Pembroke Pines, Florida, 33028, United States

  • Mercy Clinic Cancer & Hematology

    Springfield, Missouri, 65804, United States

  • Minnesota Oncology Hematology, Pa

    Minneapolis, Minnesota, 55407, United States

  • Mount Vernon Hospital

    Middlesex, HA6 2RN, United Kingdom

  • NS-Long Island Jewish Hlth Sys

    Lake Success, New York, 11042, United States

  • Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie

    Warsaw, 02-781, Poland

  • National Cancer Center

    Gyeonggi-do, 10408, South Korea

  • National Taiwan Uni Hospital

    Taipei, 100, Taiwan

  • Ninewells Hospital

    Dundee, DD12 9SY, United Kingdom

  • Northwest Cancer Specialists - Portland (N Broadway)

    Portland, Oregon, 97227, United States

  • Northwest Georgia Oncology Centers PC - Marietta

    Marietta, Georgia, 30060, United States

  • Northwest Medical Specialties

    Tacoma, Washington, 98405, United States

  • Nottingham City Hospital

    Nottingham, NG5 1PB, United Kingdom

  • Odense Universitetshospital, Onkologisk Afdeling R

    Odense, 5000, Denmark

  • Oncology Assoc of Cedar Rapids

    Cedar Rapids, Iowa, 52403, United States

  • Oslo Universitetssykehus HF

    Oslo, 0310, Norway

  • Ospedale Civile

    Sassari, Sardinia, 07100, Italy

  • Ospedale Regionale Di Parma

    Parma, Emilia-Romagna, 43100, Italy

  • Ospedale San Carlo

    Potenza, Basilicate, 85100, Italy

  • Ottawa Regional Cancer Centre

    Ottawa, Ontario, K1Y 4K7, Canada

  • Peninsula and South Eastern Haematology and Oncology Group

    Frankston, Victoria, 3199, Australia

  • Peter MacCallum Cancer Center

    Melbourne, Victoria, 3000, Australia

  • Poole General Hospital

    Poole, BH15 2JB, United Kingdom

  • Private Health Organization Acibadem Sistina Hospital

    Skopje, 1000, North Macedonia

  • Queen Mary Hospital

    Hong Kong, Hong Kong

  • Queen's Hospital

    Romford, RM7 0AG, United Kingdom

  • RCCS - Centro di Riferimento

    Aviano (PN), Friuli Venezia Giulia, 33081, Italy

  • Rajavithi Hospital

    Bangkok, 10400, Thailand

  • Rocky Mountain Cancer Center - Denver

    Denver, Colorado, 80220, United States

  • Rotkreuzklinikum München

    München, 80637, Germany

  • Royal Cornwall Hospital

    Truro, TR1 3LJ, United Kingdom

  • Royal Free Hospital

    London, NW3 2QG, United Kingdom

  • Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust

    Lancaster, LA1 4RP, United Kingdom

  • SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary

    Stavropol, 355045, Russia

  • SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan

    Ufa, Bashkortostan Republic, 450054, Russia

  • SHATO - Sofia

    Sofia, 1756, Bulgaria

  • Samsung Medical Center

    Seoul, 135-710, South Korea

  • Sarah Cannon Research Institute / Tennessee Oncology

    Chattanooga, Tennessee, 37404, United States

  • Sarah Cannon Research Institute / Tennessee Oncology

    Nashville, Tennessee, 37203, United States

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, SK S7N 4H4, Canada

  • Seoul National University Hospital

    Seoul, 110744, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Shaare Zedek Medical Center

    Jerusalem, 91031, Israel

  • St. Barnabas Health Care Sys

    Livingston, New Jersey, 07039, United States

  • St. John's Mercy Medical Ctr

    St Louis, Missouri, 63141, United States

  • Stanford Cancer Institute

    Stanford, California, 94305-5456, United States

  • Studienzentrum Aschaffenburg

    Aschaffenburg, 63739, Germany

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, 510120, China

  • Sun Yet-sen University Cancer Center

    Guangzhou, 510060, China

  • Szent Margit Hospital

    Budapest, 1031, Hungary

  • Tel Aviv Sourasky Medical Ctr

    Tel Aviv, 6423906, Israel

  • Texas Oncology

    Bedford, Texas, 76022, United States

  • Texas Oncology - Dallas Presbyterian Hospital

    Dallas, Texas, 75231, United States

  • The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)

    Beijing, 100071, China

  • The Mark H. Zangmeister Ctr

    Columbus, Ohio, 43219, United States

  • The Panama Clinic

    Panama City, 0832, Panama

  • UCLA Oncology Office

    Santa Monica, California, 90404, United States

  • USO

    Plano, Texas, 75075-7787, United States

  • USO - Tyler Cancer Ctr

    Tyler, Texas, 75702, United States

  • UZ Gent

    Ghent, 9000, Belgium

  • Uni of Washington Medical Center

    Seattle, Washington, 98109-1023, United States

  • Univ of Calif, San Francisco

    San Francisco, California, 94115, United States

  • Univ of Colorado Canc Ctr

    Aurora, Colorado, 80045, United States

  • Univ of WA Medical Center

    Seattle, Washington, 98109, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Minnesota.

    Minneapolis, Minnesota, 55455, United States

  • Universitätsspital Zürich

    Zurich, 8091, Switzerland

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952, Poland

  • Vall d'Hebron Institute of Oncology (VHIO), Barcelona

    Barcelona, 08035, Spain

  • Vejle Sygehus

    Vejle, 7100, Denmark

  • Veterans Memorial Medical Ctr

    Quezon City, 1101, Philippines

  • Western General Hospital

    Edinburgh, EH4 2XU, United Kingdom

  • Wielkopolskie Centrum Onkologii

    Poznan, 61-866, Poland

  • Wojewódzki Szpital Specjalistyczny Nr 3

    Rybnik, 44-200, Poland

  • ZAS Sint Augustinus Wilrijk, Pharmacy

    Wilrijk, 2610, Belgium

  • Zhejiang Cancer Hospital

    Hangzhou, 310022, China

  • Zhejiang Provincial People's Hospital

    Hangzhou, 310014, China

  • the First Hospital of Jilin University

    Changchun, 130021, China

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