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ACTIVE NOT RECRUITING

NCT00781612

PHASE2

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

Sponsor: Genentech, Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

378

Start Date

2008-10-16

Completion Date

2027-06-30

Last Updated

2026-08-28

Healthy Volunteers

Conditions

Neoplasm Metastasis

Interventions

DRUG

Docetaxel

Docetaxel will be administered as per local prescribing information.

DRUG

Paclitaxel

Paclitaxel will be administered as per local prescribing information.

DRUG

Pertuzumab

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).

DRUG

Trastuzumab

Trastuzumab will be administered as per local prescribing information.

DRUG

Trastuzumab Emtansine

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).

DRUG

Atezolizumab

Atezolizumab will be administered at a dose of 1200 mg by IV infusion every three weeks (Q3W)

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

Locations (179)

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

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

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)

St. 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

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

Mercy Clinic Cancer & Hematology

Springfield, Missouri, United States

St. John's Mercy Medical Ctr

St Louis, 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

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

Sarah Cannon Research Institute / Tennessee Oncology

Chattanooga, Tennessee, United States

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

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

Peter MacCallum Cancer Center

Melbourne, Victoria, Australia

UZ Gent

Ghent, Belgium

ZAS Sint Augustinus Wilrijk, Pharmacy

Wilrijk, Belgium

Clinica de Oncologia de Porto Alegre - CliniOnco

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, Brazil

Clinica de Neoplasias Litoral

Itajaí, Santa Catarina, Brazil

Faculdade de Medicina do ABC - FMABC

Santo André, São Paulo, Brazil

Hospital Perola Byington

São 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

Québec, 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

Sun Yet-sen University Cancer Center

Guangzhou, China

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

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, China

Jiangsu Cancer Hospital

Nanjing, China

Fudan University Shanghai Cancer Center

Shanghai, China

Fakultni nemocnice Olomouc

Olomouc, Czechia

Fakultni Poliklinika Vseobecne Fakultni Niemocnice

Prague, 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

Institut Curie

Paris, France

Institut Curie - Hopital Rene Huguenin

Saint-Cloud, France

Ico Rene Gauducheau

Saint-Herblain, France

Studienzentrum Aschaffenburg

Aschaffenburg, Germany

Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche

Berlin, Germany

HELIOS Klinikum Berlin-Buch

Berlin, Germany

Rotkreuzklinikum München

München, Germany

Klinikum der Universität München

München, 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

Shaare Zedek Medical Center

Jerusalem, Israel

And 79 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (179)