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

NCT03371017 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: MO391932016-005119-42
• Study Type: interventional
• Target: 595
• Locations: 27 countries
• Sites: 123

Brief Summary

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).

Conditions

Triple Negative Breast Neoplasms

Outcome Measures

Primary Outcomes (2)

• Overall Survival (OS) in PD-L1-positive Population

  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

  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 Outcomes (22)

• 12-month Survival Rate in PD-L1-positive Population

  12 months

• 12-month Survival Rate in mITT Population

  12 months

• 18-month Survival Rate in PD-L1-positive Population

  18 months

• 18-month Survival Rate in mITT Population

  18 months

• Progression-free Survival (PFS) in PD-L1-positive Population

  Time from randomization to the first occurrence of PD or death (Up to 68 months)

Other Outcomes (10)

• OS in China Population

  Time from randomization to death (Up to 68 months)

• 12-month Survival Rate in China Population

  12 months

• 18-month Survival Rate in China Population

  18 months

Study Arms (2)

Atezolizumab

EXPERIMENTAL

Participants will receive Atezolizumab on day 1 of each 3-week treatment cycle

Drug: Atezolizumab; Drug: Gemcitabine; Drug: Capecitabine; Drug: Carboplatin

Placebo

PLACEBO COMPARATOR

Participants will receive Placebo on day 1 of each 3-week treatment cycle

Drug: Placebo; Drug: Gemcitabine; Drug: Capecitabine; Drug: Carboplatin

Interventions

Atezolizumab DRUG

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

Atezolizumab

Placebo DRUG

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

Placebo

Gemcitabine DRUG

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

Atezolizumab; Placebo

Capecitabine DRUG

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

Atezolizumab; Placebo

Carboplatin DRUG

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

Atezolizumab; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (124)

Florida Cancer Specialists - Fort Myers (Broadway)

Fort Myers, Florida, 33916, United States

Location

Florida Cancer Specialists & Research Institute

St. Petersburg, Florida, 33705, United States

Location

The Valley Hospital

Paramus, New Jersey, 07652, United States

Location

Magee-Woman's Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

Location

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

Location

Hospital Provincial del Centenario

Rosario, 2000, Argentina

Location

Instituto de Oncología de Rosario

Rosario, S2000KZE, Argentina

Location

Clinical center University of Sarajevo

Sarajevo, 71000, Bosnia and Herzegovina

Location

Oncocentro Serviços Medicos E Hospitalares Ltda

Fortaleza, Ceará, 60130-241, Brazil

Location

Hospital Araujo Jorge

Goiânia, Goiás, 74605-070, Brazil

Location

Hospital do Cancer de Pernambuco - HCP

Recife, Pernambuco, 50040-000, Brazil

Location

Hospital Sao Vicente de Paulo

Passo Fundo, Rio Grande do Sul, 99010-090, Brazil

Location

Hospital Nossa Senhora da Conceicao

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

Location

Centro de Oncologia de Santa Catarina LTDA

Chapecó, Santa Catarina, 89812-211, Brazil

Location

Instituto de Pesquisa Grupo NotreDame Intermedica

São Paulo, São Paulo, 01229-010, Brazil

Location

Hospital Perola Byington

São Paulo, São Paulo, 01317-000, Brazil

Location

Núcleo de Pesquisa São Camilo

São Paulo, São Paulo, 03102-002, Brazil

Location

Bradford Hill Centro de Investigaciones Clinicas

Recoleta, 8420383, Chile

Location

Clinica Vespucio

Santiago, 8241479, Chile

Location

the First Affiliated Hospital of Bengbu Medical College

Anhui, DUMMY_VALUE, China

Location

Cancer Hospital , Chinese Academy of Medical

Beijing, 100021, China

Location

Peking University People's Hospital

Beijing, 100044, China

Location

Beijing Cancer Hospital

Beijing, 100142, China

Location

Jilin Cancer Hospital

Changchun, 132013, China

Location

The First Affiliated Hospital, Chongqing Medical University

Chongqing, 400016, China

Location

Fujian Medical University Union Hospital

Fujian, 350001, China

Location

Sun Yat-sen Memorial Hospital

Guangzhou, 510000, China

Location

Sir Run Run Shaw Hospital Zhejiang University

Hangzhou, 310016, China

Location

Zhejiang Cancer Hospital

Hangzhou, 310022, China

Location

Harbin Medical University Cancer Hospital

Harbin, 150081, China

Location

The First Affiliated Hospital Of Jinzhou Medical University

Jinzhou, 121001, China

Location

Jiangsu Province Hospital

Nanjing, 210036, China

Location

The Affiliated Hospital of Medical College Qingdao University

Qingdao, 266003, China

Location

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

Shanxi Province Cancer Hospital

Taiyuan, DUMMY_VALUE, China

Location

Tianjin Cancer Hospital

Tianjin, 300060, China

Location

The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)

Xi'an, 710032, China

Location

Hospital Hermanos Ameijeiras

La Habana, 10300, Cuba

Location

Instituto Nacional de Oncología y Radiología (INOR)

La Habana, 10400, Cuba

Location

Helsinki University Central Hospital

Helsinki, 00029, Finland

Location

Tampere University Hospital

Tampere, 33520, Finland

Location

Centre Georges-François Lecler

Dijon, 21034, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Institut Paoli-Calmettes

Marseille, 13009, France

Location

Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque

Montpellier, 34298, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

IGR

Villejuif, 94800, France

Location

Universitätsklinikum "Carl Gustav Carus"

Dresden, 01307, Germany

Location

Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH

Essen, 45136, Germany

Location

Varisano Klinikum Frankfurt Höchst GmbH

Frankfurt, 65929, Germany

Location

Universitätsklinikum Halle (Saale)

Halle, 06120, Germany

Location

Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe

Hanover, 30625, Germany

Location

Nationales Centrum für Tumorerkrankungen (NCT)

Heidelberg, 69120, Germany

Location

Medizinisches Zentrum für Hämatologie und Onkologie

München, 80639, Germany

Location

Szent Margit Hospital

Budapest, 1032, Hungary

Location

Orszagos Onkologiai Intezet

Budapest, 1122, Hungary

Location

Budapesti Uzsoki Utcai Kórház

Budapest, 1145, Hungary

Location

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

Miskolc, 3526, Hungary

Location

Pécsi Tudományegyetem

Pécs, 7623, Hungary

Location

Ospedale Antonio Perrino

Brindisi, Apulia, 72100, Italy

Location

Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

Napoli, Campania, 80131, Italy

Location

Azienda Ospedaliero Universitaria San Martino

Genoa, Liguria, 16132, Italy

Location

Ospedale San Raffaele S.r.l.

Milan, Lombardy, 20132, Italy

Location

Irccs Istituto Europeo Di Oncologia (IEO)

Milan, Lombardy, 20141, Italy

Location

Ospedale San Gerardo

Monza, Lombardy, 20900, Italy

Location

Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo

Candiolo, Piedmont, 10060, Italy

Location

Azienda Ospedaliero-Universitaria Careggi

Florence, Tuscany, 50134, Italy

Location

IRCCS Istituto Oncologico Veneto (IOV)

Padua, Veneto, 35128, Italy

Location

Kazakh Scientific Research Institution Of Oncology and Radiology

Almaty, 050022, Kazakhstan

Location

Centro Medico Dalinde

Mexico City, Mexico CITY (federal District), 06760, Mexico

Location

Instituto Nacional de Cancerologia

Distrito Federal, 14080, Mexico

Location

CENEIT Oncologicos

Mexico City, 03100, Mexico

Location

Clinical Center of Montenegro

Podgorica, 81000, Montenegro

Location

Centre Hospitalier Universitaire Hassan II

Fes, 30000, Morocco

Location

Centre Hospitalier Universitaire Mohamed VI

Marrakesh, 40000, Morocco

Location

Clinique specialise Menara

Marrakesh, 40000, Morocco

Location

The Panama Clinic

Panama City, 32400, Panama

Location

Instituto Nacional de Enfermedades Neoplasicas

Lima, Lima 34, Peru

Location

?wi?tokrzyskie Centrum Onkologii

Kielce, 25-734, Poland

Location

Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad

Warsaw, 02-781, Poland

Location

Hospital de Santa Maria

Lisbon, 1649-035, Portugal

Location

Centro Hospitalar do Porto ? Hospital de Santo António

Porto, 4099-001, Portugal

Location

Moscow City Oncology Hospital #62

Moscovskaya Oblast, Moscow Oblast, 143423, Russia

Location

Moscow Clinical Scientific Center

Moscow, Moscow Oblast, 111123, Russia

Location

FSBI "National Medical Research Center of Oncology N.N. Blokhin?

Moscow, Moscow Oblast, 115478, Russia

Location

Private Healthcare Institution Clinical Hospital RZhD Medicine

Saint Petersburg, Sankt-Peterburg, 195271, Russia

Location

City Clinical Oncology Dispensary, SPb SBIH CCOD

Saint Petersburg, Sankt-Peterburg, 198255, Russia

Location

FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

Saint Petersburg, Sankt-Peterburg, DUMMY_VALUE, Russia

Location

Institute of Oncology and Radiology of Serbia

Belgrade, 11000, Serbia

Location

University Hospital Medical Center Bezanijska kosa

Belgrade, 11080, Serbia

Location

Oncology Institute of Vojvodina

Kamenitz, 21204, Serbia

Location

Clinical Centre Nis, Clinic for Oncology

Niš, 18000, Serbia

Location

National Cancer Centre

Singapore, 168583, Singapore

Location

Wits Clinical Research

Johannesburg, 2193, South Africa

Location

Medical Oncology Centre of Rosebank

Johannesburg, 2196, South Africa

Location

Private Oncology Centre

Pretoria, 0081, South Africa

Location

Seoul National University Bundang Hospital

Gyeonggi-do, 13620, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Hospital de Cruces

Bilbao, Vizcaya, 48903, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

Hospital Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Clinico Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Ankara Oncology Hospital

Ankara, 06200, Turkey (Türkiye)

Location

Ege University Medical Faculty

Bornova, ?zm?r, 35100, Turkey (Türkiye)

Location

Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

Edirne, 22030, Turkey (Türkiye)

Location

Medipol University Medical Faculty

Istanbul, 34214, Turkey (Türkiye)

Location

Marmara University Pendik Training and Research Hospital

Istanbul, 34890, Turkey (Türkiye)

Location

Necmettin Erbakan University Meram Medical Faculty

Konya, 42080, Turkey (Türkiye)

Location

Velindre Cancer Centre

Cardiff, CF14 2TL, United Kingdom

Location

University Hospital Coventry

Coventry, CV2 2DX, United Kingdom

Location

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust

Lancaster, LA1 4RP, United Kingdom

Location

Barts

London, EC1M6BQ, United Kingdom

Location

Guys and St Thomas NHS Foundation Trust, Guys Hospital

London, SE1 9RT, United Kingdom

Location

Christie Hospital NHS Trust

Manchester, M20 4BX, United Kingdom

Location

Mount Vernon Cancer Centre

Northwood, HA6 2RN, United Kingdom

Location

Royal Stoke University Hospital

Stoke-on-Trent, ST4 6QG, United Kingdom

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

atezolizumab; Gemcitabine; Capecitabine; Carboplatin

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: December 13, 2017
• Study Start: January 11, 2018
• Primary Completion: October 23, 2024
• Study Completion: October 23, 2024
• Last Updated: November 12, 2025
• Results First Posted: November 12, 2025

Record last verified: 2025-10

Locations

IT (9); KA (1); FI (2); DE (7); ME (3); CL (2); PT (2); ZA (3); BR (9); HU (5); TU (6); US (6); AR (2); SG (1); FR (7); MO (3); PE (1); PL (2); CN (18); KR (5); SE (4); ES (6); CU (2); GB (9); RU (6); BO (1); PA (1)