Freitag, 6. August 2021
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JOURNAL ONKOLOGIE – STUDIE
KATE3

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)

Rekrutierend

NCT-Nummer:
NCT04740918

Studienbeginn:
Juni 2021

Letztes Update:
26.07.2021

Wirkstoff:
Trastuzumab Emtansine, Atezolizumab

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Hoffmann-La Roche

Collaborator:
-

Studienleiter

Clinical Trials
Study Director
Hoffmann-La Roche

Kontakt

Reference Study ID Number: MO42319 www.roche.com/about_roche/roche_worldwide.htm
Kontakt:
Phone: 888-662-6728 (U.S. and Canada)
E-Mail: global-roche-genentech-trials@gene.com
» Kontaktdaten anzeigen

Studienlocations
(3 von 148)

Onkologiezentrum Donauwörth Prof. (SHB) Dr. med. Dirk Hempel
86609 Donauwörth
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Onkozentrum Dres. Göhler
01127 Dresden
(Sachsen)
GermanyNoch nicht rekrutierend» Google-Maps
MVZ II Zentrum für Hämatologie und Onkologie der Niels Stensen Kliniken
49124 Georgsmarienhütte
(Niedersachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Diakovere Henriettenstift, Frauenklinik
30559 Hannover
(Niedersachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Städtisches Krankenhaus Kiel GmbH
24116 Kiel
(Schleswig-Holstein)
GermanyNoch nicht rekrutierend» Google-Maps
St. Elisabeth-Krankenhaus; Brustzentrum
50935 Köln
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Orange Coast Memorial Medical Center
92708 Fountain Valley
United StatesNoch nicht rekrutierend» Google-Maps
Emad Ibrahim, Md, Inc
92373 Redlands
United StatesRekrutierend» Google-Maps
Northwest Georgia Oncology Centers PC - Marietta
30060 Marietta
United StatesRekrutierend» Google-Maps
Mercy Health Research
63141 Saint Louis
United StatesZurückgezogen» Google-Maps
San Juan Oncology Associates, PC
87401 Farmington
United StatesRekrutierend» Google-Maps
Clinical Research Alliance
11590 Westbury
United StatesRekrutierend» Google-Maps
UPMC - Hillman Cancer Center
15232 Pittsburgh
United StatesRekrutierend» Google-Maps
Lake Macquarie Private Hospital
2290 Gateshead
AustraliaRekrutierend» Google-Maps
Royal North Shore Hospital; Oncology
2065 St. Leonards
AustraliaRekrutierend» Google-Maps
Princess Alexandra Hospital
4102 Woolloongabba
AustraliaRekrutierend» Google-Maps
Peter MacCallum Cancer Center
3002 East Melbourne
AustraliaNoch nicht rekrutierend» Google-Maps
Hospital Sao Rafael - HSR
41253-190 Salvador
BrazilRekrutierend» Google-Maps
Hospital do Cancer de Pernambuco - HCP
50040-000 Recife
BrazilRekrutierend» Google-Maps
Hospital de Caridade de Ijui; Oncologia
98700-000 Ijui
BrazilRekrutierend» Google-Maps
Hospital de Base de Sao Jose do Rio Preto
15090-000 Sao Jose do Rio Preto
BrazilRekrutierend» Google-Maps
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
01317-001 Sao Paulo
BrazilRekrutierend» Google-Maps
Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA
04014-002 Sao Paulo
BrazilRekrutierend» Google-Maps
Lakeridge Health Oshawa; Oncology
L1G 2B9 Oshawa
CanadaRekrutierend» Google-Maps
The Ottawa Hospital Cancer Centre; Oncology
K1H 8L6 Ottawa
CanadaRekrutierend» Google-Maps
Sunnybrook Research Institute
M4N 3M5 Toronto
CanadaRekrutierend» Google-Maps
Centre Hospitalier de l'Université de Montréal (CHUM)
H2X 0C2 Montreal
CanadaRekrutierend» Google-Maps
McGill University Health Center
H4A 3J1 Montreal
CanadaRekrutierend» Google-Maps
Jewish General Hospital; Research Unit
H3T 1E2 Montréal
CanadaRekrutierend» Google-Maps
CHUS (Centre Hospitalier Universitaire de Sherbrooke)
J1H 5N4 Sherbrooke
CanadaRekrutierend» Google-Maps
Peking University People's Hospital
100044 Beijing
ChinaNoch nicht rekrutierend» Google-Maps
Beijing Cancer Hospital
100142 Beijing
ChinaNoch nicht rekrutierend» Google-Maps
The First Hospital of Jilin University
130021 Changchun City
ChinaNoch nicht rekrutierend» Google-Maps
Hunan Cancer Hospital
410013 Changsha City
ChinaNoch nicht rekrutierend» Google-Maps
Sun Yat-sen Memorial Hospital, Sun Yat-sen University; Breast Tumor Center
510120 Guangzhou City
ChinaNoch nicht rekrutierend» Google-Maps
The Second Affiliated Hospital, Zhejiang University
310009 Hangzhou
ChinaNoch nicht rekrutierend» Google-Maps
Zhejiang Provincial People's Hospital; Oncology& Breast
310014 Hangzhou
ChinaNoch nicht rekrutierend» Google-Maps
Harbin Medical University Cancer Hospital
150081 Harbin
ChinaNoch nicht rekrutierend» Google-Maps
Yunnan Cancer Hospital; Breast Surgery
Kunming
ChinaNoch nicht rekrutierend» Google-Maps
The Affiliated Hospital of Southwest Medical University; Oncology
646000 LuZhou
ChinaNoch nicht rekrutierend» Google-Maps
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
210029 Nanjing City
ChinaNoch nicht rekrutierend» Google-Maps
Peking University Shenzhen Hospital
518036 Shenzhen
ChinaNoch nicht rekrutierend» Google-Maps
Tianjin Medical University Cancer Institute & Hospital
300060 Tianjing
ChinaNoch nicht rekrutierend» Google-Maps
Union Hospital Tongji Medical College Huazhong University of Science and Technology
430023 Wuhan City
ChinaNoch nicht rekrutierend» Google-Maps
Shanxi Provincial People's Hospital
710068 Xian
ChinaRekrutierend» Google-Maps
Zhejiang Cancer Hospital
310022 Zhejiang
ChinaNoch nicht rekrutierend» Google-Maps
Henan Cancer Hospital
450008 Zhengzhou
ChinaNoch nicht rekrutierend» Google-Maps
Oncólogos de Occidente
600004 Pereira
ColombiaNoch nicht rekrutierend» Google-Maps
Clinical Hospital Centre Split
21000 Split
CroatiaRekrutierend» Google-Maps
Clinical Hospital Center Sestre Milosrdnice; Clinic for tumors
10000 Zagreb
CroatiaNoch nicht rekrutierend» Google-Maps
Clinical Hospital Centre Zagreb
10000 Zagreb
CroatiaNoch nicht rekrutierend» Google-Maps
Kasr Eieny Uni Hospital; Oncology (Nemrock)
11555 Cairo
EgyptNoch nicht rekrutierend» Google-Maps
El Mokatam HIO Hospital
11654 Cairo
EgyptNoch nicht rekrutierend» Google-Maps
Helsinki University Central Hospital; Dept of Oncology
00029 Helsinki
FinlandRekrutierend» Google-Maps
Oulu University Hospital; Oncology
90029 Oulu
FinlandRekrutierend» Google-Maps
Tampere University Hospital; Dept of Oncology
33520 Tampere
FinlandRekrutierend» Google-Maps
CHU Amiens - Hopital Sud
80054 Amiens
FranceNoch nicht rekrutierend» Google-Maps
Polyclinique Bordeaux Nord Aquitaine
33300 Bordeaux
FranceNoch nicht rekrutierend» Google-Maps
Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie
38043 Grenoble
FranceNoch nicht rekrutierend» Google-Maps
Centre Oscar Lambret; Senologie
59020 Lille
FranceNoch nicht rekrutierend» Google-Maps
Centre Antoine Lacassagne, Centre de Lutte Contre le Cancer (CLCC) de Nice
06189 Nice
FranceNoch nicht rekrutierend» Google-Maps
Groupe Hospitalier Diaconesses Croix Saint-Simon - Site Reuilly)
75020 Paris
FranceNoch nicht rekrutierend» Google-Maps
Chu La Miletrie; Oncologie Medicale
86021 Poitiers
FranceNoch nicht rekrutierend» Google-Maps
Institut Curie - Hopital Rene Huguenin
92211 Saint-Cloud
FranceNoch nicht rekrutierend» Google-Maps
Institut Universitaire du Cancer de Toulouse-Oncopole
31059 Toulouse
FranceNoch nicht rekrutierend» Google-Maps
Centre Alexis Vautrin; Oncologie Medicale
54519 Vandoeuvre-les-nancy
FranceNoch nicht rekrutierend» Google-Maps
Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
115 22 Athens
GreeceNoch nicht rekrutierend» Google-Maps
Alexandras General Hospital of Athens; Oncology Department
115 28 Athens
GreeceNoch nicht rekrutierend» Google-Maps
University General Hospital of Heraklion;Internal Medicine-Oncology Clinic
711 10 Heraklion, Crete
GreeceNoch nicht rekrutierend» Google-Maps
Euromedical General Clinic of Thessaloniki; Oncology Department
546450 Thessaloniki
GreeceRekrutierend» Google-Maps
Szent Margit Hospital
1032 Budapest
HungaryNoch nicht rekrutierend» Google-Maps
Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
1122 Budapest
HungaryNoch nicht rekrutierend» Google-Maps
Debreceni Egyetem Klinikai Kozpont ; Department of Oncology
4032 Debrecen
HungaryRekrutierend» Google-Maps
Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly
3501 Miskolc
HungaryRekrutierend» Google-Maps
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati
83100 Avellino
ItalyRekrutierend» Google-Maps
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica
80131 Napoli
ItalyRekrutierend» Google-Maps
Università degli Studi Federico II; Clinica di Oncologia Medica
80131 Napoli
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera S. Orsola-Malpighi
40138 Bologna
ItalyRekrutierend» Google-Maps
Azienda Unità Sanitaria Locale di Reggio Emilia/IRCCS
42123 Reggio Emilia
ItalyRekrutierend» Google-Maps
Ospedale Policlinico San Martino; Ist. di Ricovero e Cura a Carattere Scientifico per l'Oncologia
16132 Genova
ItalyNoch nicht rekrutierend» Google-Maps
Ospedale San Raffaele; Medical Oncology
20132 Milano
ItalyRekrutierend» Google-Maps
Azienda Ospedaliero Universitaria Pisana
56100 Pisa
ItalyRekrutierend» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Asan Medical Center
05505 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Korea University Guro Hospital
08308 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Haukeland universitetssjukehus, Avd. for kreftbehandling og medisinsk fysikk
5021 Bergen
NorwayNoch nicht rekrutierend» Google-Maps
Sykehuset Østfold Kalnes; Onkologisk seksjon
1714 Grålum
NorwayNoch nicht rekrutierend» Google-Maps
Oslo Universitetssykehus HF; Ullevål sykehus
0450 Oslo
NorwayNoch nicht rekrutierend» Google-Maps
Stavanger Universitetssykehus, Helse Stavanger HF
4011 Stavanger
NorwayNoch nicht rekrutierend» Google-Maps
Cebu Doctors' University Hospital; Research Office
6000 Cebu City
PhilippinesNoch nicht rekrutierend» Google-Maps
St. Luke's Medical Center; Human Cancer Biobank Research Center
1102 Quezon City
PhilippinesNoch nicht rekrutierend» Google-Maps
Cardinal Santos Medical Center; Lower Ground Floor Research Room, Cancer Center
1502 San Juan
PhilippinesNoch nicht rekrutierend» Google-Maps
Copernicus Podmiot Medyczny Sp. z o.o. Wojewodzkie Centrum Onkologii
80-219 Gdansk
PolandRekrutierend» Google-Maps
Przychodnia Lekarska KOMED, Roman Karaszewski
62-500 Konin
PolandRekrutierend» Google-Maps
Szpital Wojewódzki im. Mikołaja Kopernika; Oddział Dzienny Chemioterapii
75-581 Koszalin
PolandRekrutierend» Google-Maps
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
30-688 Kraków
PolandNoch nicht rekrutierend» Google-Maps
Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna
90-242 Lodz
PolandRekrutierend» Google-Maps
Opolskie Centrum Onkologii;Oddzial Onkologii Klinicznej
45-060 Opole
PolandRekrutierend» Google-Maps
Szpital Kliniczny; Przemienienia Panskiego;Uniwersytetu Medyczny im.; Karola Marcinkowskiego w Pozna
60-569 Poznan
PolandRekrutierend» Google-Maps
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
02-781 Warszawa
PolandRekrutierend» Google-Maps
Mazowiecki Szpital Onkologiczny
05-135 Wieliszew
PolandRekrutierend» Google-Maps
IPO de Lisboa; Servico de Oncologia Medica
1099-023 Lisboa
PortugalNoch nicht rekrutierend» Google-Maps
Centro Clinico Champalimaud; Oncologia Medica
1400-038 Lisboa
PortugalNoch nicht rekrutierend» Google-Maps
Hospital de Santa Maria; Servico de Oncologia Medica
1649-035 Lisboa
PortugalNoch nicht rekrutierend» Google-Maps
Centro Hospitalar do Porto - Hospital de Santo António; Oncologia
4099-001 Porto
PortugalRekrutierend» Google-Maps
IPO do Porto; Servico de Oncologia Medica
4200-072 Porto
PortugalRekrutierend» Google-Maps
FSBSI "N. N. Blokhin Russian Cancer Research Center"
115478 Moscow
Russian FederationNoch nicht rekrutierend» Google-Maps
City Clinical Oncology Dispensary, SPb SBIH CCOD
198255 Saint-Petersburg
Russian FederationRekrutierend» Google-Maps
Samara Regional Oncology Dispensary
443031 Samara
Russian FederationRekrutierend» Google-Maps
State Healthcare Institution "Regional Clinical Oncology Dispensary"
410053 Saratov
Russian FederationNoch nicht rekrutierend» Google-Maps
St. Petersburg Clinical Scientific Center of special services medical assis (oncology)
197758 ST Petersburg
Russian FederationNoch nicht rekrutierend» Google-Maps
SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan
450054 Ufa
Russian FederationRekrutierend» Google-Maps
Institute of Oncology Ljubljana
1000 Ljubljana
SloveniaRekrutierend» Google-Maps
Hospital Provincial de Castellon; Servicio de Oncologia
12002 Castellon de La Plana
SpainRekrutierend» Google-Maps
Hospital Universitario Quiron Madrid; Servicio de Oncologia
28223 Pozuelo de Alarcón
SpainRekrutierend» Google-Maps
Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro; Servicio de Oncología
36312 Vigo
SpainRekrutierend» Google-Maps
Hospital Universitari Vall d'Hebron; Oncology
08035 Barcelona
SpainNoch nicht rekrutierend» Google-Maps
Hospital Universitario La Paz; Servicio de Oncologia
28046 Madrid
SpainNoch nicht rekrutierend» Google-Maps
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
29010 Malaga
SpainZurückgezogen» Google-Maps
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
29011 Malaga
SpainRekrutierend» Google-Maps
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
41013 Sevilla
SpainRekrutierend» Google-Maps
Adana Baskent University Medical Faculty; Oncology
01220 Adana
TurkeyRekrutierend» Google-Maps
Sakarya Universitesi Egitim ve Arastirma Hastanesi
54100 Adapazari/Sakarya
TurkeyRekrutierend» Google-Maps
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
34147 Bakirkoy / Istanbul
TurkeyNoch nicht rekrutierend» Google-Maps
Acibadem University School of Medicine Altunizade Hospital Oncology Service
34742 Istanbul
TurkeyRekrutierend» Google-Maps
Katip Celebi University Ataturk Training and Research Hospital; Oncology
35360 Izmir
TurkeyRekrutierend» Google-Maps
Inonu University Faculty of Medicine Turgut Ozal Medical Center; Onkoloji, Elazig Yolu,
44280 Malatya
TurkeyRekrutierend» Google-Maps
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
06230 Sihhiye/Ankara
TurkeyRekrutierend» Google-Maps
Western General Hospital; Edinburgh Cancer Center
EH4 2XU Edinburgh
United KingdomNoch nicht rekrutierend» Google-Maps
Leicester Royal Infirmary NHS Trust
LE1 5WW Leicester
United KingdomNoch nicht rekrutierend» Google-Maps
UCL Hospital NHS Trust
NW1 2PG London
United KingdomNoch nicht rekrutierend» Google-Maps
Guys and St Thomas NHS Foundation Trust, Guys Hospital
SE1 9RT London
United KingdomNoch nicht rekrutierend» Google-Maps
The Christie NHS Foundation Trust
M20 4BX Manchester
United KingdomNoch nicht rekrutierend» Google-Maps
Milton Keynes University Hospital
MK6 5LD Milton Keynes
United KingdomNoch nicht rekrutierend» Google-Maps
Nottingham University Hospitals City Campus; Nottingham Cancer Clinical Trials Team
NG5 1PB Nottingham
United KingdomNoch nicht rekrutierend» Google-Maps
Peterborough City Hospital
PE3 9GZ Peterborough
United KingdomNoch nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Progression-Free Survival (PFS) as Determined by Investigator's Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) (Time Frame - Baseline until disease progression, death or end of study (approximately 78 months))

2. Overall Survival (OS) (Time Frame - From baseline until death or end of study (approximately 78 months))

Secondary outcome:

1. 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))

2. 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))

3. PFS as Determined by a Blinded Independent Central Review Committee Using RECIST v1.1 (Time Frame - Baseline until disease progression, death or end of study (approximately 78 months))

4. 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))

5. OS in Participants with Baseline Brain Metastases (Time Frame - From baseline until death or end of study (approximately 78 months))

6. 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))

7. 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) (Time Frame - From Cycle 1 until 3 months after study completion)

8. Mean Change-From-Baseline Scores in Function (Physical, Role) and GHS/QoL as Measured by the EORTC QLQ-C30 (Time Frame - From Cycle 1 until 3 months after study completion)

9. Percentage of Participants with Clinically Meaningful Deterioration in GHS/QoL Physical, and Role Function as Measured by the EORTC QLQ-C30 (Time Frame - From Cycle 1 until 3 months after study completion)

10. 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))

11. Maximum Serum Concentration (Cmax) of Trastuzumab Emtansine (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))

12. Cmax of Atezolizumab (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))

13. Percentage of Participants With Anti-Drug Antibodies (ADAs) to Trastuzumab Emtansine (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))

14. Percentage of Participants With ADAs to Atezolizumab (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))

Studien-Arme

  • Active Comparator: Arm A: Trastuzumab Emtansine and Placebo
    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.
  • Experimental: Arm B: Trastuzumab Emtansine and Atezolizumab
    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.

Geprüfte Regime

  • Trastuzumab Emtansine (Kadcyla, T-DM1, RO5304020):
    Trastuzumab emtansine 3.6 mg/kg IV infusion
  • Atezolizumab (Tecentriq, RO5541267, MPDL3280A):
    Atezolizumab 1200 mg IV infusion
  • Placebo:
    Placebo matched to atezolizumab

Quelle: ClinicalTrials.gov


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