A Study of the Efficacy and Safety of Atezolizumab Plus Chemotherapy for Patients With Early Relapsing Recurrent Triple-Negative Breast Cancer (IMpassion132)

October 29, 2025 updated by: Hoffmann-La Roche

A Phase III, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study Of The Efficacy And Safety Of Atezolizumab Plus Chemotherapy For Patients With Early Relapsing Recurrent (Inoperable Locally Advanced Or Metastatic) Triple-Negative Breast Cancer

This study will evaluate the efficacy and safety of atezolizumab plus chemotherapy compared with placebo plus chemotherapy in patients with inoperable recurrent triple-negative breast cancer (TNBC).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
595

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Rosario, Argentina, S2000KZE
        • Instituto de Oncologia de Rosario
      • Rosario, Argentina, 2000
        • Hospital Provincial del Centenario
  • Bosnia and Herzegovina
      • Sarajevo, Bosnia and Herzegovina, 71000
        • Clinical Center University of Sarajevo
  • Brazil
    • Ceará
      • Fortaleza, Ceará, Brazil, 60130-241
        • Oncocentro Serviços Médicos e Hospitalares Ltda
    • Goiás
      • Goiânia, Goiás, Brazil, 74605-070
        • Hospital Araujo Jorge
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50040-000
        • Hospital do Cancer de Pernambuco - HCP
    • Rio Grande do Sul
      • Passo Fundo, Rio Grande do Sul, Brazil, 99010-090
        • Hospital São Vicente de Paulo
      • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
        • Hospital Nossa Senhora da Conceicao
    • Santa Catarina
      • Chapecó, Santa Catarina, Brazil, 89812-211
        • Centro de Oncologia de Santa Catarina LTDA
    • São Paulo
      • São Paulo, São Paulo, Brazil, 03102-002
        • Núcleo de Pesquisa São Camilo
      • São Paulo, São Paulo, Brazil, 01317-000
        • Hospital Perola Byington
      • São Paulo, São Paulo, Brazil, 01229-010
        • Instituto de Pesquisa Grupo NotreDame Intermedica
  • Chile
      • Recoleta, Chile, 8420383
        • Bradford Hill Centro de Investigaciones Clinicas
      • Santiago, Chile, 8241479
        • Clínica Vespucio
  • China
      • Anhui, China, DUMMY_VALUE
        • The First Affiliated Hospital of Bengbu Medical College
      • Beijing, China, 100142
        • Beijing Cancer Hospital
      • Beijing, China, 100044
        • Peking University People's Hospital
      • Beijing, China, 100021
        • Cancer Hospital , Chinese Academy of Medical
      • Changchun, China, 132013
        • Jilin Cancer Hospital
      • Chongqing, China, 400016
        • The First Affiliated Hospital, Chongqing Medical University
      • Fujian, China, 350001
        • Fujian Medical University Union Hospital
      • Guangzhou, China, 510000
        • Sun Yat-Sen Memorial Hospital
      • Hangzhou, China, 310022
        • Zhejiang Cancer Hospital
      • Hangzhou, China, 310016
        • Sir Run Run Shaw Hospital Zhejiang University
      • Harbin, China, 150081
        • Harbin Medical University Cancer Hospital
      • Jinzhou, China, 121001
        • The First Affiliated Hospital of Jinzhou Medical University
      • Nanjing, China, 210036
        • Jiangsu Province Hospital
      • Qingdao, China, 266003
        • The Affiliated Hospital of Medical College Qingdao University
      • Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center
      • Taiyuan, China, DUMMY_VALUE
        • Shanxi Province Cancer Hospital
      • Tianjin, China, 300060
        • Tianjin Cancer Hospital
      • Xi'an, China, 710032
        • The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)
  • Cuba
      • La Habana, Cuba, 10300
        • Hospital Hermanos Ameijeiras
      • La Habana, Cuba, 10400
        • Instituto Nacional de Oncología y Radiología (INOR)
  • Finland
      • Helsinki, Finland, 00029
        • Helsinki University Central Hospital
      • Tampere, Finland, 33520
        • Tampere University Hospital
  • France
      • Dijon, France, 21034
        • Centre Georges-François Lecler
      • Lyon, France, 69373
        • Centre Leon Berard
      • Marseille, France, 13009
        • Institut Paoli-Calmettes
      • Montpellier, France, 34298
        • Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque
      • Rennes, France, 35042
        • Centre Eugene Marquis
      • Vandœuvre-lès-Nancy, France, 54511
        • Centre Alexis Vautrin
      • Villejuif, France, 94800
        • IGR
  • Germany
      • Dresden, Germany, 01307
        • Universitätsklinikum "Carl Gustav Carus"
      • Essen, Germany, 45136
        • Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH
      • Frankfurt, Germany, 65929
        • Varisano Klinikum Frankfurt Höchst GmbH
      • Halle, Germany, 06120
        • Universitätsklinikum Halle (Saale)
      • Hanover, Germany, 30625
        • Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe
      • Heidelberg, Germany, 69120
        • Nationales Centrum für Tumorerkrankungen (NCT)
      • München, Germany, 80639
        • Medizinisches Zentrum für Hämatologie und Onkologie
  • Hungary
      • Budapest, Hungary, 1122
        • Országos Onkológiai Intézet
      • Budapest, Hungary, 1032
        • Szent Margit Hospital
      • Budapest, Hungary, 1145
        • Budapesti Uzsoki Utcai Kórház
      • Miskolc, Hungary, 3526
        • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
      • Pécs, Hungary, 7623
        • Pécsi Tudományegyetem
  • Italy
    • Apulia
      • Brindisi, Apulia, Italy, 72100
        • Ospedale Antonio Perrino
    • Campania
      • Napoli, Campania, Italy, 80131
        • Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
    • Liguria
      • Genoa, Liguria, Italy, 16132
        • Azienda Ospedaliero Universitaria San Martino
    • Lombardy
      • Milan, Lombardy, Italy, 20141
        • Irccs Istituto Europeo Di Oncologia (IEO)
      • Milan, Lombardy, Italy, 20132
        • Ospedale San Raffaele S.r.l.
      • Monza, Lombardy, Italy, 20900
        • Ospedale San Gerardo
    • Piedmont
      • Candiolo, Piedmont, Italy, 10060
        • Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo
    • Tuscany
      • Florence, Tuscany, Italy, 50134
        • Azienda Ospedaliero-Universitaria Careggi
    • Veneto
      • Padua, Veneto, Italy, 35128
        • IRCCS Istituto Oncologico Veneto (IOV)
  • Kazakhstan
      • Almaty, Kazakhstan, 050022
        • Kazakh Scientific Research Institution Of Oncology and Radiology
  • Mexico
      • Distrito Federal, Mexico, 14080
        • Instituto Nacional De Cancerologia
      • Mexico City, Mexico, 03100
        • CENEIT Oncologicos
    • Mexico CITY (federal District)
      • Mexico City, Mexico CITY (federal District), Mexico, 06760
        • Centro Medico Dalinde
  • Montenegro
      • Podgorica, Montenegro, 81000
        • Clinical Center of Montenegro
  • Morocco
      • Fes, Morocco, 30000
        • Centre Hospitalier Universitaire Hassan II
      • Marrakesh, Morocco, 40000
        • Centre Hospitalier Universitaire Mohamed VI
      • Marrakesh, Morocco, 40000
        • Clinique specialise Menara
  • Panama
      • Panama City, Panama, 32400
        • The Panama Clinic
  • Peru
      • Lima, Peru, Lima 34
        • Instituto Nacional de Enfermedades Neoplasicas
  • Poland
      • Kielce, Poland, 25-734
        • ?wi?tokrzyskie Centrum Onkologii
      • Warsaw, Poland, 02-781
        • Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad
  • Portugal
      • Lisbon, Portugal, 1649-035
        • Hospital de Santa Maria
      • Porto, Portugal, 4099-001
        • Centro Hospitalar do Porto ? Hospital de Santo António
  • Russia
    • Moscow Oblast
      • Moscovskaya Oblast, Moscow Oblast, Russia, 143423
        • Moscow City Oncology Hospital #62
      • Moscow, Moscow Oblast, Russia, 111123
        • Moscow Clinical Scientific Center
      • Moscow, Moscow Oblast, Russia, 115478
        • FSBI "National Medical Research Center of Oncology N.N. Blokhin?
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russia, 195271
        • Private Healthcare Institution Clinical Hospital RZhD Medicine
      • Saint Petersburg, Sankt-Peterburg, Russia, 198255
        • City Clinical Oncology Dispensary, SPb SBIH CCOD
      • Saint Petersburg, Sankt-Peterburg, Russia, DUMMY_VALUE
        • FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
  • Serbia
      • Belgrade, Serbia, 11000
        • Institute of Oncology and Radiology of Serbia
      • Belgrade, Serbia, 11080
        • University Hospital Medical Center Bezanijska Kosa
      • Kamenitz, Serbia, 21204
        • Oncology Institute of Vojvodina
      • Niš, Serbia, 18000
        • Clinical Centre Nis, Clinic for Oncology
  • Singapore
      • Singapore, Singapore, 168583
        • National Cancer Centre
  • South Africa
      • Johannesburg, South Africa, 2196
        • Medical Oncology Centre of Rosebank
      • Johannesburg, South Africa, 2193
        • Wits Clinical Research
      • Pretoria, South Africa, 0081
        • Private Oncology Centre
  • South Korea
      • Gyeonggi-do, South Korea, 13620
        • Seoul National University Bundang Hospital
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 06351
        • Samsung Medical Center
      • Seoul, South Korea, 03722
        • Severance Hospital, Yonsei University Health System
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon
      • Málaga, Spain, 29010
        • Hospital Clinico Universitario Virgen de la Victoria
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48903
        • Hospital De Cruces
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06200
        • Ankara Oncology Hospital
      • Bornova, ?zm?r, Turkey (Türkiye), 35100
        • Ege University Medical Faculty
      • Edirne, Turkey (Türkiye), 22030
        • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
      • Istanbul, Turkey (Türkiye), 34214
        • Medipol University Medical Faculty
      • Istanbul, Turkey (Türkiye), 34890
        • Marmara University Pendik Training and Research Hospital
      • Konya, Turkey (Türkiye), 42080
        • Necmettin Erbakan University Meram Medical Faculty
  • United Kingdom
      • Cardiff, United Kingdom, CF14 2TL
        • Velindre Cancer Centre
      • Coventry, United Kingdom, CV2 2DX
        • University Hospital Coventry
      • Edinburgh, United Kingdom, EH4 2XU
        • Western General Hospital
      • Lancaster, United Kingdom, LA1 4RP
        • Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust
      • London, United Kingdom, SE1 9RT
        • Guys and St Thomas NHS Foundation Trust, Guys Hospital
      • London, United Kingdom, EC1M6BQ
        • Barts
      • Manchester, United Kingdom, M20 4BX
        • Christie Hospital Nhs Trust
      • Northwood, United Kingdom, HA6 2RN
        • Mount Vernon Cancer Centre
      • Stoke-on-Trent, United Kingdom, ST4 6QG
        • Royal Stoke University Hospital
  • United States
    • Florida
      • Fort Myers, Florida, United States, 33916
        • Florida Cancer Specialists - Fort Myers (Broadway)
      • St. Petersburg, Florida, United States, 33705
        • Florida Cancer Specialists & Research Institute
    • New Jersey
      • Paramus, New Jersey, United States, 07652
        • The Valley Hospital
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee-Woman's Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Scri Oncology Partners
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Inova Schar Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically confirmed triple negative breast cancer (TNBC) that is either locally recurrent, inoperable and cannot be treated with curative intent or is metastatic
  • Documented disease progression occurring within 12 months from the last treatment with curative intent
  • Prior treatment (of early breast cancer) with an anthracycline and taxane
  • Have not received prior chemotherapy or targeted systemic therapy for their locally advanced inoperable or metastatic recurrence. Prior radiation therapy for recurrent disease is permitted
  • Measurable or non-measurable disease, as defined by RECIST 1.1
  • Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumour block (preferred) or at least 17 unstained slides obtained from relapsed metastatic or locally advanced diseases may be submitted, if clinically feasible, with an associated pathology report, if available. If a fresh tumour sample is not clinically feasible, either the diagnosis sample, the primary surgical resection sample, or the most recent FFPE tumour biopsy sample should be used.
  • Eastern Cooperative Oncology Group performance status 0-1
  • Life expectancy ≥ 12 weeks
  • Adequate haematologic and end-organ function
  • Negative human immunodeficiency virus (HIV) test ---Negative hepatitis B surface antigen (HBsAg) test at screening
  • Negative total hepatitis B core antibody (HBcAb) test at screening, or positive HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening
  • The HBV DNA test will be performed only for patients who have a negative HBsAg and a positive HBcAb test.
  • Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening.
  • Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of ≤1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab or 6 months after the last dose of capecitabine, whichever is later. In addition, women must refrain from donating eggs during the same time period.
  • Men must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agree to refrain from donating sperm

Inclusion criteria for patients enrolled after the recruitment of all-comers is complete:

-PD-L1-positive tumour status (assessed centrally prior to randomisation), defined as PD-L1 expression on tumour-infiltrating immune cells (IC) of 1% or greater.

Exclusion Criteria:

  • Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for > 2 weeks prior to randomisation
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
  • Symptomatic or rapid visceral progression
  • No prior treatment with an anthracycline and taxane
  • History of leptomeningeal disease
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) (patients with indwelling catheters such as PleurX® are allowed)
  • Uncontrolled tumour-related pain
  • Uncontrolled or symptomatic hypercalcemia
  • Malignancies other than TNBC within 5 years prior to randomisation)
  • Significant cardiovascular disease, within 3 months prior to randomisation, unstable arrhythmias, or unstable angina
  • Presence of an abnormal ECG
  • Severe infection requiring oral or IV antibiotics within 4 weeks prior to randomisation, including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia.
  • Current treatment with anti-viral therapy for HBV.
  • Major surgical procedure within 4 weeks prior to randomisation or anticipation of the need for a major surgical procedure during the course of the study other than for diagnosis
  • Treatment with investigational therapy within 28 days prior to randomisation
  • Pregnant or lactating, or intending to become pregnant during or within 5 months after the last dose of atezolizumab, or within 6 months after the last dose of capecitabine, whichever is later.

Exclusion Criteria Related to Atezolizumab:

  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanised antibodies or fusion proteins
  • Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or to any component of the atezolizumab formulation
  • History of autoimmune disease
  • Prior allogeneic stem cell or solid organ transplantation
  • History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e. bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest computerised tomography (CT) scan History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
  • Active tuberculosis
  • Receipt of a live, attenuated vaccine within 4 weeks prior to randomisation or anticipation that a live, attenuated vaccine will be required during atezolizumab/placebo treatment or within 5 months after the last dose of atezolizumab/placebo
  • Prior treatment with CD137 agonists, anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway targeting agents
  • Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin [IL]-2) within 4 weeks or five half-lives of the drug (whichever is longer) prior to randomisation
  • Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to start of study treatment, or anticipated requirement for systemic immunosuppressive medications during the trial

Exclusion Criteria Related to Capecitabine:

  • Inability to swallow pills
  • Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach or small bowel, or ulcerative colitis
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency or history of severe and unexpected reactions to fluoropyrimidine therapy in patients selected to receive capecitabine

Exclusion Criteria Related to Carboplatin/Gemcitabine:

-Hypersensitivity to platinum containing compounds or any component of carboplatin or gemcitabine drug formulations in patients selected to receive carboplatin and Gemcitabine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Atezolizumab
Participants will receive Atezolizumab on day 1 of each 3-week treatment cycle
Drug: Atezolizumab

Atezolizumab will be administered, 1200 mg by IV infusion with :

gemcitabine 1000 mg/m2, followed by carboplatin target area under the curve (AUC) 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each 3-week treatment cycle or with capecitabine 1000 mg/m2, twice daily orally on Days 1 to 14, followed by a 7-day rest period in each 3-week treatment cycle

Drug: Gemcitabine
Gemcitabine 1000 mg/m2, followed by carboplatin target area under the curve (AUC) 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each 3-week treatment cycle
Drug: Capecitabine
Capecitabine 1000 mg/m2, twice daily orally on Days 1 to 14, followed by a 7-day rest period in each 3-week treatment cycle
Drug: Carboplatin
Carboplatin target area under the curve (AUC) 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each 3-week treatment cycle
Placebo Comparator: Placebo
Participants will receive Placebo on day 1 of each 3-week treatment cycle
Drug: Gemcitabine
Gemcitabine 1000 mg/m2, followed by carboplatin target area under the curve (AUC) 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each 3-week treatment cycle
Drug: Capecitabine
Capecitabine 1000 mg/m2, twice daily orally on Days 1 to 14, followed by a 7-day rest period in each 3-week treatment cycle
Drug: Carboplatin
Carboplatin target area under the curve (AUC) 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each 3-week treatment cycle
Drug: Placebo

Placebo will be administered, 1200 mg by IV infusion with :

gemcitabine 1000 mg/m2, followed by carboplatin target area under the curve (AUC) 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each 3-week treatment cycle or with capecitabine 1000 mg/m2, twice daily orally on Days 1 to 14, followed by a 7-day rest period in each 3-week treatment cycle

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) in PD-L1-positive Population
Time Frame: Time from randomization to death (Up to 68 months)
OS was defined as time from randomization to death from any cause. Participants without a reported death event at the time of the analysis were censored on the date they were last known to be alive. If no post-baseline data were available, OS was censored at the date of randomization +1 day.
Time from randomization to death (Up to 68 months)
OS in Modified Intent-to-treat (mITT) Population
Time Frame: Time from randomization to death (Up to 68 months)
OS was defined as time from randomization to death from any cause. Participants without a reported death event at the time of the analysis were censored on the date they were last known to be alive. If no post-baseline data were available, OS was censored at the date of randomization +1 day.
Time from randomization to death (Up to 68 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
12-month Survival Rate in PD-L1-positive Population
Time Frame: 12 months
12-month survival rate was defined as the percentage of participants alive 12 months after randomization. The 12-month survival rates were estimated by Kaplan-Meier methodology. Percentages have been rounded off to the nearest whole number.
12 months
12-month Survival Rate in mITT Population
Time Frame: 12 months
12-month survival rate was defined as the percentage of participants alive 12 months after randomization. The 12-month survival rates were estimated by Kaplan-Meier methodology. Percentages have been rounded off to nearest whole number.
12 months
18-month Survival Rate in PD-L1-positive Population
Time Frame: 18 months
18-month survival rate was defined as the percentage of participants alive 18 months after randomization. The 18-month survival rates were estimated by Kaplan-Meier methodology. Percentages have been rounded off to nearest whole number.
18 months
18-month Survival Rate in mITT Population
Time Frame: 18 months
18-month survival rate was defined as the percentage of participants alive 18 months after randomization. The 18-month survival rates were estimated by Kaplan-Meier methodology. Percentages have been rounded off to nearest whole number.
18 months
Progression-free Survival (PFS) in PD-L1-positive Population
Time Frame: Time from randomization to the first occurrence of PD or death (Up to 68 months)
PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 millimeters (mm). Data for participants not experiencing PD or death were censored at the last tumour assessment date. If no tumor assessment was performed after randomisation, data were censored at the date of randomisation +1 day.
Time from randomization to the first occurrence of PD or death (Up to 68 months)
PFS in mITT Population
Time Frame: Time from randomization to the first occurrence of PD or death (Up to 68 months)
PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Data for participants not experiencing PD or death were censored at the last tumour assessment date. If no tumor assessment was performed after randomisation, data were censored at the date of randomisation +1 day.
Time from randomization to the first occurrence of PD or death (Up to 68 months)
Objective Response Rate (ORR) in Response-evaluable Population, Subset of PD-L1-positive Population
Time Frame: Baseline up to end of study (Up to 68 months)
ORR was defined as percentage of participants with measurable disease at baseline who achieved a documented unconfirmed objective response (OR). OR was defined as either a complete response (CR) or a partial response (PR), as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off to nearest whole number.
Baseline up to end of study (Up to 68 months)
ORR in Response-evaluable Population, Subset of mITT Population
Time Frame: Baseline up to end of study (Up to 68 months)
ORR was defined as percentage of participants with measurable disease at baseline who achieved a documented unconfirmed OR. OR was defined as either a CR or PR, as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off to nearest whole number.
Baseline up to end of study (Up to 68 months)
Duration of Objective Response (DoR) in DoR-evaluable Population Subset of PD-L1-positive Population
Time Frame: Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months)
DoR was defined as the time from the first occurrence of a documented unconfirmed response (CR or PR) until the date of PD as determined by the investigator from tumor assessments using RECIST v1.1 or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.
Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months)
DoR in DoR-evaluable Population Subset of mITT Population
Time Frame: Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months)
DoR was defined as the time from the first occurrence of a documented unconfirmed response (CR or PR) until the date of PD as determined by the investigator from tumor assessments using RECIST v1.1 or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.
Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months)
Clinical Benefit Rate (CBR) in Response-evaluable Population Subset of PD-L1-positive Population
Time Frame: Up to 68 months
CBR was defined as the percentage of participants with either an unconfirmed CR or PR or stable disease (SD) that lasts at least 6 months as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Percentages have been rounded off to nearest whole number.
Up to 68 months
CBR in Response-evaluable Population Subset of mITT Population
Time Frame: Up to 68 months
CBR was defined as the percentage of participants with either an unconfirmed CR or PR or SD that lasts at least 6 months as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Percentages have been rounded off to nearest whole number.
Up to 68 months
Confirmed Objective Response Rate (C-ORR) in Response-evaluable Population Subset of PD-L1-positive Population
Time Frame: Up to 68 months
C-ORR was defined as percentage of participants with measurable disease at baseline who achieved a documented confirmed OR. OR was defined as either a CR or PR, as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off to nearest whole number.
Up to 68 months
C-ORR in Response-evaluable Population Subset of mITT Population
Time Frame: Up to 68 months
C-ORR was defined as percentage of participants with measurable disease at baseline who achieved a documented confirmed OR. OR was defined as either a CR or PR, as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off to nearest whole number.
Up to 68 months
DoR for Confirmed Responders (C-DoR) in C-DoR-evaluable Population Subset of PD-L1-positive Population
Time Frame: Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months)
C-DoR was defined as the time from the first occurrence of a documented confirmed response (CR or PR) until the date of PD as determined by the investigator from tumor assessments using RECIST v1.1 or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.
Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months)
C-DoR in C-DoR-evaluable Population Subset of mITT Population
Time Frame: Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months)
C-DoR was defined as the time from the first occurrence of a documented confirmed response (CR or PR) until the date of PD as determined by the investigator from tumor assessments using RECIST v1.1 or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.
Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months)
Time to Confirmed Deterioration (TTD) in Global Health Status/Quality of Life (GHS/QoL) According to the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) in PD-L1-positive Population
Time Frame: Up to 68 months
TTD in GHS/QoL, defined by a minimally important decrease of ≥10 points at 2 consecutive assessment time-points on the GHS/QoL scale (Items 29, 30) of EORTC QLQ-C30, which consists of 30 questions that assess 5 aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, & six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Participant responses to questions regarding GHS (Question 29: GHS; "How would you rate your overall health during the past week?") & QoL (Question 30: QoL; "How would you rate your overall quality of life during the past week?") were assessed & were scored on a 7-point scale (1= Very poor; 7=Excellent). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating better QoL.
Up to 68 months
TTD in GHS/QoL According to EORTC QLQ-C30 in mITT Population
Time Frame: Up to 68 months
TTD in GHS/QoL, defined by a minimally important decrease of ≥10 points at 2 consecutive assessment time-points on the GHS/QoL scale (Items 29, 30) of EORTC QLQ-C30, which consists of 30 questions that assess 5 aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, & six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Participant responses to questions regarding GHS (Question 29: GHS; "How would you rate your overall health during the past week?") & QoL (Question 30: QoL; "How would you rate your overall quality of life during the past week?") were assessed & were scored on a 7-point scale (1= Very poor; 7=Excellent). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating better QoL.
Up to 68 months
Number of Participants With Adverse Events (AEs)
Time Frame: From treatment initiation up to 90 days after last dose (up to 71 months)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions that worsen during a study are also considered AEs.
From treatment initiation up to 90 days after last dose (up to 71 months)
Serum Concentration of Atezolizumab
Time Frame: Pre-dose on Day 1 of Cycles 1, 2, 3 and 4; Post-dose on Day 1 of Cycles 1 and 3 and Treatment Discontinuation Visit (up to 69 months) (1 Cycle= 3 weeks)
Pre-dose on Day 1 of Cycles 1, 2, 3 and 4; Post-dose on Day 1 of Cycles 1 and 3 and Treatment Discontinuation Visit (up to 69 months) (1 Cycle= 3 weeks)
Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
Time Frame: Cycles 1 to 4 and Treatment Discontinuation visit (up to 69 months)
Number of ADA-positive participants after drug administration was determined for participants exposed to atezolizumab. For determining post-baseline incidence, participants were considered to be ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure, or if they were ADA-positive at baseline and the titer of 1 or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the baseline titer result. The sum of participants who were ADA-positive at postbaseline visits of Cycles 1 to 4 and treatment discontinuation has been reported here.
Cycles 1 to 4 and Treatment Discontinuation visit (up to 69 months)
Number of Participants With PD-L1 Protein Expression in Screening Tumour Tissue and Post-baseline Assessment
Time Frame: Baseline up to 68 months
Baseline up to 68 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
OS in China Population
Time Frame: Time from randomization to death (Up to 68 months)
OS was defined as time from randomization to death from any cause.
Time from randomization to death (Up to 68 months)
12-month Survival Rate in China Population
Time Frame: 12 months
12-month survival rate was defined as the percentage of participants alive 12 months after randomization.
12 months
18-month Survival Rate in China Population
Time Frame: 18 months
18-month survival rate was defined as the percentage of participants alive 18 months after randomization.
18 months
PFS in China Population
Time Frame: Time from randomization to the first occurrence of PD or death (Up to 68 months)
PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST 1.1, or death from any cause, whichever occurs first.
Time from randomization to the first occurrence of PD or death (Up to 68 months)
ORR in China Population
Time Frame: Baseline up to end of study (Up to 68 months)
ORR was defined as percentage of participants with measurable disease at baseline who achieved a documented unconfirmed OR. OR was defined as either a CR or PR, as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR.
Baseline up to end of study (Up to 68 months)
DoR in China Population
Time Frame: Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months)
DoR was defined as the time from the first occurrence of a documented unconfirmed response (CR or PR) until the date of PD as determined by the investigator from tumor assessments using RECIST v1.1 or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.
Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months)
CBR in China Population
Time Frame: Up to 68 months
CBR was defined as the percentage of participants with either an unconfirmed CR or PR or SD that lasts at least 6 months as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm.
Up to 68 months
C-ORR in China Population
Time Frame: Up to 68 months
C-ORR was defined as percentage of participants with measurable disease at baseline who achieved a documented confirmed OR. OR was defined as either a CR or PR, as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR.
Up to 68 months
C-DoR in China Population
Time Frame: Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months)
C-DoR was defined as the time from the first occurrence of a documented confirmed response (CR or PR) until the date of PD as determined by the investigator from tumor assessments using RECIST v1.1 or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.
Time from the first occurrence of a documented OR until the date of PD/death (Up to 68 months)
TTD in GHS/QoL According to EORTC QLQ-C30 in China Population
Time Frame: Up to 68 months
TTD in GHS/QoL, defined by a minimally important decrease of ≥10 points at 2 consecutive assessment time-points on the GHS/QoL scale (Items 29, 30) of EORTC QLQ-C30, which consists of 30 questions that assess 5 aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, & six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Participant responses to questions regarding GHS (Question 29: GHS; "How would you rate your overall health during the past week?") & QoL (Question 30: QoL; "How would you rate your overall quality of life during the past week?") were assessed & were scored on a 7-point scale (1= Very poor; 7=Excellent). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating better QoL.
Up to 68 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 11, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 23, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 23, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MO39193
  • 2016-005119-42 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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