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A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC) (KATE3)

Primary Purpose

Metastatic Breast Cancer

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Trastuzumab Emtansine
Atezolizumab
Placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • HER2+ and PD-L1+ locally advanced (LABC) or metastatic breast cancer (MBC)
  • Progression must have occurred during most recent treatment for LABC/MBC or during, or within 6 months after completing, neoadjuvant and/or adjuvant therapy
  • Prior treatment with trastuzumab (+/- pertuzumab) and taxane in the neoadjuvant and/or adjuvant, locally advanced, or metastatic setting
  • No more than two prior lines of therapy in the metastatic setting
  • Measurable disease per RESIST version 1.1
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Life expectancy >= 6 months
  • Adequate hematologic and end-organ function
  • For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs
  • For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm

Exclusion Criteria:

  • Prior treatment with trastuzumab emtansine in metastatic setting
  • History of exposure to cumulative doses of anthracyclines
  • Symptomatic or actively progressing central nervous system (CNS) metastases; asymptomatic CNS lesions ≤ 2cm without clinical requirement for local intervention or asymptomatic patients with treated CNS lesions are eligible
  • Current Grade >= 3 peripheral neuropathy
  • Cardiopulmonary dysfunction
  • History of malignancy within 5 years prior to initiation of study treatment, with the exception of the cancer under investigation and malignancies with a negligible risk of metastasis or death
  • History of leptomeningeal disease
  • Active or history of autoimmune disease or immune deficiency
  • Active hepatitis B, hepatitis C and/or tuberculosis
  • Prior allogeneic stem cell or solid organ transplantation
  • Receipt of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, during treatment, or within 5 months following the last dose of study treatment
  • Pregnancy or lactation

Sites / Locations

  • Orange Coast Memorial Medical Center
  • Emad Ibrahim, Md, Inc
  • Northwest Georgia Oncology Centers PC - Marietta
  • Mercy Health Research
  • San Juan Oncology Associates, PC
  • Clinical Research Alliance
  • Magee Womens Hospital
  • Lake Macquarie Private Hospital
  • Royal North Shore Hospital; Oncology
  • Princess Alexandra Hospital
  • Peter MacCallum Cancer Center
  • Sunshine Hospital
  • Hospital Sao Rafael - HSR
  • Hospital Araujo Jorge; Departamento de Ginecologia E Mama
  • Hospital do Cancer de Pernambuco - HCP
  • Hospital de Caridade de Ijui; Oncologia
  • Hospital Nossa Senhora da Conceicao
  • Hospital de Base de Sao Jose do Rio Preto
  • Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
  • Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA
  • Royal Victoria Hospital
  • Lakeridge Health Oshawa; Oncology
  • The Ottawa Hospital Cancer Centre; Oncology
  • Sunnybrook Research Institute
  • Centre Hospitalier de l?Université de Montréal (CHUM)
  • McGill University Health Center
  • Jewish General Hospital; Research Unit
  • CHUS (Centre Hospitalier Universitaire de Sherbrooke)
  • Peking University People's Hospital
  • Beijing Cancer Hospital
  • The First Hospital of Jilin University
  • Hunan Cancer HospitalRecruiting
  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University; Breast Tumor Center
  • The Second Affiliated Hospital, Zhejiang University
  • Zhejiang Provincial People's Hospital; Oncology& Breast
  • Harbin Medical University Cancer HospitalRecruiting
  • Yunnan Cancer Hospital; Breast Surgery
  • Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
  • Peking University Shenzhen Hospital
  • Tianjin Medical University Cancer Institute & Hospital
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Shanxi Provincial People's Hospital
  • Zhejiang Cancer HospitalRecruiting
  • Henan Cancer Hospital
  • Clinica Vida
  • Oncomedica S.A.
  • Oncólogos de OccidenteRecruiting
  • Clinical Hospital Centre Split
  • Clinical Hospital Center Sestre Milosrdnice; Clinic for tumors
  • Clinical Hospital Centre Zagreb
  • Kasr Eieny Uni Hospital; Oncology (Nemrock)
  • El Mokatam HIO Hospital
  • Nasser Institute
  • Baheya Hospital
  • Shifaa Al-Orman Hospital
  • Helsinki University Central Hospital; Dept of Oncology
  • Oulu University Hospital; Oncology
  • Tampere University Hospital; Dept of Oncology
  • CHU Amiens - Hopital Sud
  • Polyclinique Bordeaux Nord Aquitaine
  • Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie
  • Centre Oscar Lambret; Senologie
  • Centre Antoine Lacassagne, Centre de Lutte Contre le Cancer (CLCC) de Nice
  • Groupe Hospitalier Diaconesses Croix Saint-Simon - Site Reuilly)
  • Chu La Miletrie; Oncologie Medicale
  • Institut Curie - Hopital Rene Huguenin
  • Institut Universitaire du Cancer de Toulouse-Oncopole
  • Centre Alexis Vautrin; Oncologie Medicale
  • Onkozentrum Dres. Göhler
  • MVZ II Zentrum für Hämatologie und Onkologie der Niels Stensen Kliniken
  • Diakovere Henriettenstift, Frauenklinik
  • Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
  • Städtisches Krankenhaus Kiel GmbH
  • St. Elisabeth-Krankenhaus; Brustzentrum
  • Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
  • Alexandras General Hospital of Athens; Oncology Department
  • University General Hospital of Heraklion;Internal Medicine-Oncology Clinic
  • Euromedical General Clinic of Thessaloniki; Oncology Department
  • Budapesti Szent Margit Korhaz; Onkologia Osztaly
  • Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
  • Debreceni Egyetem Klinikai Kozpont ; Department of Oncology
  • Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly
  • Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati
  • Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica
  • Università degli Studi Federico II; Clinica di Oncologia Medica
  • Azienda Ospedaliera S. Orsola-MalpighiRecruiting
  • Azienda Unità Sanitaria Locale di Reggio Emilia/IRCCS
  • Ospedale Policlinico San Martino; Ist. di Ricovero e Cura a Carattere Scientifico per l'Oncologia
  • Asst Papa Giovanni XXIII
  • Ospedale San Raffaele; Medical Oncology
  • Istituto Europeo Di Oncologia
  • Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
  • Azienda Ospedaliero Universitaria Pisana
  • Seoul National University HospitalRecruiting
  • Asan Medical Center
  • Korea University Guro Hospital
  • Haukeland universitetssjukehus, Avd. for kreftbehandling og medisinsk fysikk
  • Sykehuset Østfold Kalnes; Onkologisk seksjon
  • Oslo Universitetssykehus HF; Ullevål sykehus
  • Stavanger Universitetssykehus, Helse Stavanger HF
  • Cebu Doctors' University Hospital; Research OfficeRecruiting
  • St. Luke's Medical Center; Human Cancer Biobank Research CenterRecruiting
  • Cardinal Santos Medical Center; Lower Ground Floor Research Room, Cancer Center
  • Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna
  • Copernicus Podmiot Medyczny Sp. z o.o. Wojewodzkie Centrum Onkologii
  • Przychodnia Lekarska KOMED, Roman Karaszewski
  • Szpital Wojewódzki im. Miko?aja Kopernika; Oddzia? Dzienny Chemioterapii
  • Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
  • Opolskie Centrum Onkologii;Oddzial Onkologii Klinicznej
  • Szpital Kliniczny; Przemienienia Panskiego;Uniwersytetu Medyczny im.; Karola Marcinkowskiego w Pozna
  • Centrum Onkologii ? Instytut im. Marii Sk?odowskiej-Curie Klinika Nowotworów Piersi i ChirurgiiRecruiting
  • Mazowiecki Szpital Onkologiczny
  • IPO de Lisboa; Servico de Oncologia Medica
  • Centro Clinico Champalimaud; Oncologia Medica
  • Hospital de Santa Maria; Servico de Oncologia Medica
  • Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia
  • IPO do Porto; Servico de Oncologia Medica
  • SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan
  • FSBSI ?N. N. Blokhin Russian Cancer Research Center?
  • City Clinical Oncology Dispensary, SPb SBIH CCOD
  • St. Petersburg Clinical Scientific Center of special services medical assis (oncology)
  • Samara Regional Oncology Dispensary
  • State Healthcare Institution ?Regional Clinical Oncology Dispensary?
  • Institute of Oncology Ljubljana
  • Hospital Provincial de Castellon; Servicio de Oncologia
  • Hospital Universitario Quiron Madrid; Servicio de Oncologia
  • Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro; Servicio de Oncología
  • Hospital Universitari Vall d'Hebron; Oncology
  • Hospital Universitario La Paz; Servicio de Oncologia
  • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
  • Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
  • Hospital Universitario Virgen del Rocio; Servicio de Oncologia
  • Adana Baskent University Medical Faculty; Oncology
  • Sakarya Universitesi Egitim ve Arastirma Hastanesi
  • Memorial Ankara HastanesiRecruiting
  • Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
  • Acibadem University School of Medicine Altunizade Hospital Oncology ServiceRecruiting
  • Katip Celebi University Ataturk Training and Research Hospital; OncologyRecruiting
  • Kayseri Acibadem HospitalRecruiting
  • Inonu University Faculty of Medicine Turgut Ozal Medical Center; Onkoloji, Elazig Yolu,Recruiting
  • Hacettepe Uni Medical Faculty Hospital; Oncology DeptRecruiting
  • Leicester Royal Infirmary NHS Trust
  • UCL Hospital NHS TrustRecruiting
  • Guys and St Thomas NHS Foundation Trust, Guys HospitalRecruiting
  • The Christie NHS Foundation TrustRecruiting
  • Milton Keynes University Hospital
  • Nottingham University Hospitals City Campus; Nottingham Cancer Clinical Trials TeamRecruiting
  • Peterborough City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A: Trastuzumab Emtansine and Placebo

Arm B: Trastuzumab Emtansine and Atezolizumab

Arm Description

Placebo matched to atezolizumab followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor.

Atezolizumab 1200 mg IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor.

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS) as Determined by Investigator's Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)
Following the Sponsor's decision to prematurely terminate the study, no formal testing will be performed and the outcome measure will only be reported in a descriptive way.
Overall Survival (OS)
Following the Sponsor's decision to prematurely terminate the study, no formal testing will be performed and the outcome measure will only be reported in a descriptive way.

Secondary Outcome Measures

Percentage of Participants With Objective Response Rate (ORR) as Determined by Investigator's Assessment Using RECIST v1.1
Duration of Objective Response (DOR) as Determined by Investigator Assessment Using RECIST v1.1
PFS as Determined by a Blinded Independent Central Review Committee Using RECIST v1.1
Following the Sponsor's decision to prematurely terminate the study, this analysis will not be conducted.
PFS in Participants with Baseline Brain Metastases as Determined by Investigator Assessment Using RECIST v1.1
OS in Participants with Baseline Brain Metastases
Central Nervous System (CNS) PFS as Determined by Investigator Assessment Using RECIST v1.1 in Participants with or Without Baseline CNS Metastases
Mean Absolute Scores in Function (Physical, Role) and Global Health Status (GHS)/Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30)
Following the Sponsor's decision to prematurely terminate the study, this analysis will not be conducted.
Mean Change-From-Baseline Scores in Function (Physical, Role) and GHS/QoL as Measured by the EORTC QLQ-C30
Following the Sponsor's decision to prematurely terminate the study, this analysis will not be conducted.
Percentage of Participants with Clinically Meaningful Deterioration in GHS/QoL Physical, and Role Function as Measured by the EORTC QLQ-C30
Following the Sponsor's decision to prematurely terminate the study, this analysis will not be conducted.
Percentage of Participants with Adverse Events (AEs) According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0
Maximum Serum Concentration (Cmax) of Trastuzumab Emtansine
Following the Sponsor's decision to prematurely terminate the study, this outcome measure is no longer applicable. Accordingly, the corresponding analysis will not be performed.
Cmax of Atezolizumab
Following the Sponsor's decision to prematurely terminate the study, this outcome measure is no longer applicable. Accordingly, the corresponding analysis will not be performed.
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Trastuzumab Emtansine
Following the Sponsor's decision to prematurely terminate the study, this outcome measure is no longer applicable. Accordingly, the corresponding analysis will not be performed.
Percentage of Participants With ADAs to Atezolizumab
Following the Sponsor's decision to prematurely terminate the study, this outcome measure is no longer applicable. Accordingly, the corresponding analysis will not be performed.

Full Information

First Posted
February 3, 2021
Last Updated
October 20, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT04740918
Brief Title
A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC)
Acronym
KATE3
Official Title
A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase III Study of the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo in Patients With HER2-Positive and PD-L1-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab- (+/- Pertuzumab) and Taxane-Based Therapy (KATE3)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the efficacy, safety and patient-reported outcomes of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo in participants with HER2-positive and PD-L1-positive LABC or MBC.Participants must have progressed either during or after prior trastuzumab- (+/- pertuzumab) and taxane-based therapy for LABC/MBC; or during (or within 6 months after completing) trastuzumab- (+/-pertuzumab) and taxane-based therapy in the neoadjuvant and/or adjuvant setting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Trastuzumab Emtansine and Placebo
Arm Type
Active Comparator
Arm Description
Placebo matched to atezolizumab followed by trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the sponsor.
Arm Title
Arm B: Trastuzumab Emtansine and Atezolizumab
Arm Type
Experimental
Arm Description
Atezolizumab 1200 mg IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion on Day 1 Cycle 1 and thereafter on Day 1 of each 21-day cycle until disease progression, unmanageable toxicity, or study termination by the Sponsor.
Intervention Type
Drug
Intervention Name(s)
Trastuzumab Emtansine
Other Intervention Name(s)
Kadcyla, T-DM1, RO5304020
Intervention Description
Trastuzumab emtansine 3.6 mg/kg IV infusion
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
Tecentriq, RO5541267, MPDL3280A
Intervention Description
Atezolizumab 1200 mg IV infusion
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo matched to atezolizumab
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) as Determined by Investigator's Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)
Description
Following the Sponsor's decision to prematurely terminate the study, no formal testing will be performed and the outcome measure will only be reported in a descriptive way.
Time Frame
Baseline until disease progression, death or end of study (approximately 78 months)
Title
Overall Survival (OS)
Description
Following the Sponsor's decision to prematurely terminate the study, no formal testing will be performed and the outcome measure will only be reported in a descriptive way.
Time Frame
From baseline until death or end of study (approximately 78 months)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Objective Response Rate (ORR) as Determined by Investigator's Assessment Using RECIST v1.1
Time Frame
Baseline until disease progression, death or end of study (approximately 78 months)
Title
Duration of Objective Response (DOR) as Determined by Investigator Assessment Using RECIST v1.1
Time Frame
Baseline until disease progression, death or end of study (approximately 78 months)
Title
PFS as Determined by a Blinded Independent Central Review Committee Using RECIST v1.1
Description
Following the Sponsor's decision to prematurely terminate the study, this analysis will not be conducted.
Time Frame
Baseline until disease progression, death or end of study (approximately 78 months)
Title
PFS in Participants with Baseline Brain Metastases as Determined by Investigator Assessment Using RECIST v1.1
Time Frame
Baseline until disease progression, death or end of study (approximately 78 months)
Title
OS in Participants with Baseline Brain Metastases
Time Frame
From baseline until death or end of study (approximately 78 months)
Title
Central Nervous System (CNS) PFS as Determined by Investigator Assessment Using RECIST v1.1 in Participants with or Without Baseline CNS Metastases
Time Frame
Baseline until disease progression, death or end of study (approximately 78 months)
Title
Mean Absolute Scores in Function (Physical, Role) and Global Health Status (GHS)/Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30)
Description
Following the Sponsor's decision to prematurely terminate the study, this analysis will not be conducted.
Time Frame
From Cycle 1 until 3 months after study completion
Title
Mean Change-From-Baseline Scores in Function (Physical, Role) and GHS/QoL as Measured by the EORTC QLQ-C30
Description
Following the Sponsor's decision to prematurely terminate the study, this analysis will not be conducted.
Time Frame
From Cycle 1 until 3 months after study completion
Title
Percentage of Participants with Clinically Meaningful Deterioration in GHS/QoL Physical, and Role Function as Measured by the EORTC QLQ-C30
Description
Following the Sponsor's decision to prematurely terminate the study, this analysis will not be conducted.
Time Frame
From Cycle 1 until 3 months after study completion
Title
Percentage of Participants with Adverse Events (AEs) According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0
Time Frame
Baseline up to end of study (approximately 78 months)
Title
Maximum Serum Concentration (Cmax) of Trastuzumab Emtansine
Description
Following the Sponsor's decision to prematurely terminate the study, this outcome measure is no longer applicable. Accordingly, the corresponding analysis will not be performed.
Time Frame
Day 1 of Cycles 1, 2 and 4 (each cycle=21 days) and during study treatment completion/early discontinuation visit (approximately 78 months)
Title
Cmax of Atezolizumab
Description
Following the Sponsor's decision to prematurely terminate the study, this outcome measure is no longer applicable. Accordingly, the corresponding analysis will not be performed.
Time Frame
Day 1 of Cycles 1, 2, 3, 4 and 8 and every 8 cycles thereafter (each cycle=21 days) and during study treatment completion/early discontinuation visit (approximately 78 months)
Title
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Trastuzumab Emtansine
Description
Following the Sponsor's decision to prematurely terminate the study, this outcome measure is no longer applicable. Accordingly, the corresponding analysis will not be performed.
Time Frame
Day 1 of Cycles 1, 2 and 4 (each cycle=21 days) and during study treatment completion/early discontinuation visit (approximately 78 months)
Title
Percentage of Participants With ADAs to Atezolizumab
Description
Following the Sponsor's decision to prematurely terminate the study, this outcome measure is no longer applicable. Accordingly, the corresponding analysis will not be performed.
Time Frame
Day 1 of Cycles 1, 2, 3, 4 and 8 and every 8 cycles thereafter (each cycle=21 days) and during study treatment completion/early discontinuation visit (approximately 78 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HER2+ and PD-L1+ locally advanced (LABC) or metastatic breast cancer (MBC) Progression must have occurred during most recent treatment for LABC/MBC or during, or within 6 months after completing, neoadjuvant and/or adjuvant therapy Prior treatment with trastuzumab (+/- pertuzumab) and taxane in the neoadjuvant and/or adjuvant, locally advanced, or metastatic setting No more than two prior lines of therapy in the metastatic setting Measurable disease per RESIST version 1.1 Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 Life expectancy >= 6 months Adequate hematologic and end-organ function For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm Exclusion Criteria: Prior treatment with trastuzumab emtansine in metastatic setting History of exposure to cumulative doses of anthracyclines Symptomatic or actively progressing central nervous system (CNS) metastases; asymptomatic CNS lesions ≤ 2cm without clinical requirement for local intervention or asymptomatic patients with treated CNS lesions are eligible Current Grade >= 3 peripheral neuropathy Cardiopulmonary dysfunction History of malignancy within 5 years prior to initiation of study treatment, with the exception of the cancer under investigation and malignancies with a negligible risk of metastasis or death History of leptomeningeal disease Active or history of autoimmune disease or immune deficiency Active hepatitis B, hepatitis C and/or tuberculosis Prior allogeneic stem cell or solid organ transplantation Receipt of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, during treatment, or within 5 months following the last dose of study treatment Pregnancy or lactation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: MO42319 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. and Canada)
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Orange Coast Memorial Medical Center
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Withdrawn
Facility Name
Emad Ibrahim, Md, Inc
City
Redlands
State/Province
California
ZIP/Postal Code
92373
Country
United States
Individual Site Status
Completed
Facility Name
Northwest Georgia Oncology Centers PC - Marietta
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Withdrawn
Facility Name
Mercy Health Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Withdrawn
Facility Name
San Juan Oncology Associates, PC
City
Farmington
State/Province
New Mexico
ZIP/Postal Code
87401
Country
United States
Individual Site Status
Withdrawn
Facility Name
Clinical Research Alliance
City
Westbury
State/Province
New York
ZIP/Postal Code
11590
Country
United States
Individual Site Status
Withdrawn
Facility Name
Magee Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Withdrawn
Facility Name
Lake Macquarie Private Hospital
City
Gateshead
State/Province
New South Wales
ZIP/Postal Code
2290
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Royal North Shore Hospital; Oncology
City
St. Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Completed
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Peter MacCallum Cancer Center
City
North Melbourne
State/Province
Victoria
ZIP/Postal Code
3051
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Sunshine Hospital
City
St Albans
State/Province
Victoria
ZIP/Postal Code
3021
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Hospital Sao Rafael - HSR
City
Salvador
State/Province
BA
ZIP/Postal Code
41253-190
Country
Brazil
Individual Site Status
Completed
Facility Name
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
City
Goiania
State/Province
GO
ZIP/Postal Code
74605-070
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Hospital do Cancer de Pernambuco - HCP
City
Recife
State/Province
PE
ZIP/Postal Code
50040-000
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Hospital de Caridade de Ijui; Oncologia
City
Ijui
State/Province
RS
ZIP/Postal Code
98700-000
Country
Brazil
Individual Site Status
Completed
Facility Name
Hospital Nossa Senhora da Conceicao
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
91350-200
Country
Brazil
Individual Site Status
Completed
Facility Name
Hospital de Base de Sao Jose do Rio Preto
City
Sao Jose do Rio Preto
State/Province
SP
ZIP/Postal Code
15090-000
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01317-001
Country
Brazil
Individual Site Status
Completed
Facility Name
Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04014-002
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Royal Victoria Hospital
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6M2
Country
Canada
Individual Site Status
Completed
Facility Name
Lakeridge Health Oshawa; Oncology
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
The Ottawa Hospital Cancer Centre; Oncology
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Sunnybrook Research Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Completed
Facility Name
Centre Hospitalier de l?Université de Montréal (CHUM)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0C2
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
McGill University Health Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Jewish General Hospital; Research Unit
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
CHUS (Centre Hospitalier Universitaire de Sherbrooke)
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Individual Site Status
Completed
Facility Name
Peking University People's Hospital
City
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Hospital of Jilin University
City
Changchun City
ZIP/Postal Code
130021
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Hunan Cancer Hospital
City
Changsha CITY
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Name
Sun Yat-sen Memorial Hospital, Sun Yat-sen University; Breast Tumor Center
City
Guangzhou City
ZIP/Postal Code
510120
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The Second Affiliated Hospital, Zhejiang University
City
Hangzhou
ZIP/Postal Code
310009
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Zhejiang Provincial People's Hospital; Oncology& Breast
City
Hangzhou
ZIP/Postal Code
310014
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
ZIP/Postal Code
150081
Country
China
Individual Site Status
Recruiting
Facility Name
Yunnan Cancer Hospital; Breast Surgery
City
Kunming City
ZIP/Postal Code
650100
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
City
Nanjing City
ZIP/Postal Code
210029
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Peking University Shenzhen Hospital
City
Shenzhen
ZIP/Postal Code
518036
Country
China
Individual Site Status
Completed
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjin
ZIP/Postal Code
3000060
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan City
ZIP/Postal Code
430023
Country
China
Individual Site Status
Completed
Facility Name
Shanxi Provincial People's Hospital
City
Xian
ZIP/Postal Code
710068
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Zhejiang Cancer Hospital
City
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Name
Henan Cancer Hospital
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Clinica Vida
City
Medellin
Country
Colombia
Individual Site Status
Active, not recruiting
Facility Name
Oncomedica S.A.
City
Monteria
ZIP/Postal Code
230002
Country
Colombia
Individual Site Status
Active, not recruiting
Facility Name
Oncólogos de Occidente
City
Pereira
ZIP/Postal Code
600004
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Clinical Hospital Centre Split
City
Split
ZIP/Postal Code
21000
Country
Croatia
Individual Site Status
Completed
Facility Name
Clinical Hospital Center Sestre Milosrdnice; Clinic for tumors
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Completed
Facility Name
Clinical Hospital Centre Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Completed
Facility Name
Kasr Eieny Uni Hospital; Oncology (Nemrock)
City
Cairo
ZIP/Postal Code
11555
Country
Egypt
Individual Site Status
Withdrawn
Facility Name
El Mokatam HIO Hospital
City
Cairo
ZIP/Postal Code
11654
Country
Egypt
Individual Site Status
Withdrawn
Facility Name
Nasser Institute
City
Cairo
Country
Egypt
Individual Site Status
Withdrawn
Facility Name
Baheya Hospital
City
Giza
Country
Egypt
Individual Site Status
Withdrawn
Facility Name
Shifaa Al-Orman Hospital
City
Louxor
Country
Egypt
Individual Site Status
Withdrawn
Facility Name
Helsinki University Central Hospital; Dept of Oncology
City
Helsinki
ZIP/Postal Code
00250
Country
Finland
Individual Site Status
Completed
Facility Name
Oulu University Hospital; Oncology
City
Oulu
ZIP/Postal Code
90029
Country
Finland
Individual Site Status
Completed
Facility Name
Tampere University Hospital; Dept of Oncology
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Individual Site Status
Completed
Facility Name
CHU Amiens - Hopital Sud
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Completed
Facility Name
Polyclinique Bordeaux Nord Aquitaine
City
Bordeaux
ZIP/Postal Code
33300
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Completed
Facility Name
Centre Oscar Lambret; Senologie
City
Lille
ZIP/Postal Code
59020
Country
France
Individual Site Status
Completed
Facility Name
Centre Antoine Lacassagne, Centre de Lutte Contre le Cancer (CLCC) de Nice
City
Nice
ZIP/Postal Code
06189
Country
France
Individual Site Status
Completed
Facility Name
Groupe Hospitalier Diaconesses Croix Saint-Simon - Site Reuilly)
City
Paris
ZIP/Postal Code
75020
Country
France
Individual Site Status
Completed
Facility Name
Chu La Miletrie; Oncologie Medicale
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Completed
Facility Name
Institut Curie - Hopital Rene Huguenin
City
Saint-Cloud
ZIP/Postal Code
92211
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Institut Universitaire du Cancer de Toulouse-Oncopole
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Completed
Facility Name
Centre Alexis Vautrin; Oncologie Medicale
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54519
Country
France
Individual Site Status
Withdrawn
Facility Name
Onkozentrum Dres. Göhler
City
Dresden
ZIP/Postal Code
01127
Country
Germany
Individual Site Status
Withdrawn
Facility Name
MVZ II Zentrum für Hämatologie und Onkologie der Niels Stensen Kliniken
City
Georgsmarienhütte
ZIP/Postal Code
49124
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Diakovere Henriettenstift, Frauenklinik
City
Hannover
ZIP/Postal Code
30559
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Städtisches Krankenhaus Kiel GmbH
City
Kiel
ZIP/Postal Code
24116
Country
Germany
Individual Site Status
Withdrawn
Facility Name
St. Elisabeth-Krankenhaus; Brustzentrum
City
Köln
ZIP/Postal Code
50935
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
City
Athens
ZIP/Postal Code
115 22
Country
Greece
Individual Site Status
Completed
Facility Name
Alexandras General Hospital of Athens; Oncology Department
City
Athens
ZIP/Postal Code
115 28
Country
Greece
Individual Site Status
Completed
Facility Name
University General Hospital of Heraklion;Internal Medicine-Oncology Clinic
City
Heraklion, Crete
ZIP/Postal Code
711 10
Country
Greece
Individual Site Status
Completed
Facility Name
Euromedical General Clinic of Thessaloniki; Oncology Department
City
Thessaloniki
ZIP/Postal Code
546 45
Country
Greece
Individual Site Status
Completed
Facility Name
Budapesti Szent Margit Korhaz; Onkologia Osztaly
City
Budapest
ZIP/Postal Code
1032
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Debreceni Egyetem Klinikai Kozpont ; Department of Oncology
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly
City
Miskolc
ZIP/Postal Code
3501
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati
City
Avellino
State/Province
Campania
ZIP/Postal Code
83100
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Terminated
Facility Name
Università degli Studi Federico II; Clinica di Oncologia Medica
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Azienda Ospedaliera S. Orsola-Malpighi
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Unità Sanitaria Locale di Reggio Emilia/IRCCS
City
Reggio Emilia
State/Province
Emilia-Romagna
ZIP/Postal Code
42123
Country
Italy
Individual Site Status
Completed
Facility Name
Ospedale Policlinico San Martino; Ist. di Ricovero e Cura a Carattere Scientifico per l'Oncologia
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Asst Papa Giovanni XXIII
City
Bergamo
State/Province
Lombardia
ZIP/Postal Code
24100
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Ospedale San Raffaele; Medical Oncology
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Istituto Europeo Di Oncologia
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
City
Rozzano
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Haukeland universitetssjukehus, Avd. for kreftbehandling og medisinsk fysikk
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Individual Site Status
Withdrawn
Facility Name
Sykehuset Østfold Kalnes; Onkologisk seksjon
City
Grålum
ZIP/Postal Code
1714
Country
Norway
Individual Site Status
Withdrawn
Facility Name
Oslo Universitetssykehus HF; Ullevål sykehus
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Individual Site Status
Completed
Facility Name
Stavanger Universitetssykehus, Helse Stavanger HF
City
Stavanger
ZIP/Postal Code
4011
Country
Norway
Individual Site Status
Withdrawn
Facility Name
Cebu Doctors' University Hospital; Research Office
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Individual Site Status
Recruiting
Facility Name
St. Luke's Medical Center; Human Cancer Biobank Research Center
City
Quezon City
ZIP/Postal Code
1102
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Cardinal Santos Medical Center; Lower Ground Floor Research Room, Cancer Center
City
San Juan
ZIP/Postal Code
1502
Country
Philippines
Individual Site Status
Active, not recruiting
Facility Name
Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna
City
?ód?
ZIP/Postal Code
90-338
Country
Poland
Individual Site Status
Completed
Facility Name
Copernicus Podmiot Medyczny Sp. z o.o. Wojewodzkie Centrum Onkologii
City
Gdansk
ZIP/Postal Code
80-219
Country
Poland
Individual Site Status
Completed
Facility Name
Przychodnia Lekarska KOMED, Roman Karaszewski
City
Konin
ZIP/Postal Code
62-500
Country
Poland
Individual Site Status
Completed
Facility Name
Szpital Wojewódzki im. Miko?aja Kopernika; Oddzia? Dzienny Chemioterapii
City
Koszalin
ZIP/Postal Code
75-581
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
City
Kraków
ZIP/Postal Code
30-688
Country
Poland
Individual Site Status
Completed
Facility Name
Opolskie Centrum Onkologii;Oddzial Onkologii Klinicznej
City
Opole
ZIP/Postal Code
45-061
Country
Poland
Individual Site Status
Completed
Facility Name
Szpital Kliniczny; Przemienienia Panskiego;Uniwersytetu Medyczny im.; Karola Marcinkowskiego w Pozna
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Centrum Onkologii ? Instytut im. Marii Sk?odowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Recruiting
Facility Name
Mazowiecki Szpital Onkologiczny
City
Wieliszew
ZIP/Postal Code
05-135
Country
Poland
Individual Site Status
Completed
Facility Name
IPO de Lisboa; Servico de Oncologia Medica
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Individual Site Status
Completed
Facility Name
Centro Clinico Champalimaud; Oncologia Medica
City
Lisboa
ZIP/Postal Code
1400-038
Country
Portugal
Individual Site Status
Withdrawn
Facility Name
Hospital de Santa Maria; Servico de Oncologia Medica
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Completed
Facility Name
Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Individual Site Status
Active, not recruiting
Facility Name
IPO do Porto; Servico de Oncologia Medica
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Individual Site Status
Completed
Facility Name
SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan
City
Ufa
State/Province
Baskortostan
ZIP/Postal Code
450054
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
FSBSI ?N. N. Blokhin Russian Cancer Research Center?
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
115478
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
City Clinical Oncology Dispensary, SPb SBIH CCOD
City
Saint-Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
St. Petersburg Clinical Scientific Center of special services medical assis (oncology)
City
ST Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Samara Regional Oncology Dispensary
City
Samara
ZIP/Postal Code
443031
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
State Healthcare Institution ?Regional Clinical Oncology Dispensary?
City
Saratov
ZIP/Postal Code
410053
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Institute of Oncology Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Individual Site Status
Completed
Facility Name
Hospital Provincial de Castellon; Servicio de Oncologia
City
Castellon de La Plana
State/Province
Castellon
ZIP/Postal Code
12002
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitario Quiron Madrid; Servicio de Oncologia
City
Pozuelo de Alarcón
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro; Servicio de Oncología
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36312
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitari Vall d'Hebron; Oncology
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitario La Paz; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
City
Malaga
ZIP/Postal Code
29011
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Completed
Facility Name
Adana Baskent University Medical Faculty; Oncology
City
Adana
ZIP/Postal Code
01220
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Sakarya Universitesi Egitim ve Arastirma Hastanesi
City
Adapazari/Sakarya
ZIP/Postal Code
54100
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Memorial Ankara Hastanesi
City
Ankara
ZIP/Postal Code
06520
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
City
Bakirkoy / Istanbul
ZIP/Postal Code
34147
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Acibadem University School of Medicine Altunizade Hospital Oncology Service
City
Istanbul
ZIP/Postal Code
34742
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Katip Celebi University Ataturk Training and Research Hospital; Oncology
City
Izmir
ZIP/Postal Code
35360
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Kayseri Acibadem Hospital
City
Kayseri
ZIP/Postal Code
38000
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Inonu University Faculty of Medicine Turgut Ozal Medical Center; Onkoloji, Elazig Yolu,
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
City
Sihhiye/Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Leicester Royal Infirmary NHS Trust
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
UCL Hospital NHS Trust
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Guys and St Thomas NHS Foundation Trust, Guys Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Milton Keynes University Hospital
City
Milton Keynes
ZIP/Postal Code
MK6 5LD
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Nottingham University Hospitals City Campus; Nottingham Cancer Clinical Trials Team
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Peterborough City Hospital
City
Peterborough
ZIP/Postal Code
PE3 9GZ
Country
United Kingdom
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Learn more about this trial

A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC)

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