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Immunotherapy combo aims to extend lives in aggressive breast cancer

NCT ID NCT03371017

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This phase 3 trial tested whether adding the immunotherapy drug atezolizumab to standard chemotherapy helps people with triple-negative breast cancer that has returned within 12 months of initial treatment. The study enrolled 595 participants and compared survival outcomes between those receiving atezolizumab plus chemo and those receiving a placebo plus chemo. The goal was to see if the combination improves overall survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
atezolizumab (an immunotherapy drug) combined with chemotherapy (gemcitabine, carboplatin, or capecitabine)
What this could lead to
If successful, this combination could offer a new treatment option that helps people with triple-negative breast cancer live longer.
What could go wrong
This is a completed phase 3 trial, but results may not show a significant survival benefit for all participants. Immunotherapy can cause immune-related side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

595 people

The number who actually took part.

Started

Jan 2018

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Triple negative breast neoplasms

Contacts and locations

Locations

  • ?wi?tokrzyskie Centrum Onkologii

    Kielce, 25-734, Poland

  • Ankara Oncology Hospital

    Ankara, 06200, Turkey (Türkiye)

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Azienda Ospedaliero Universitaria San Martino

    Genoa, Liguria, 16132, Italy

  • Azienda Ospedaliero-Universitaria Careggi

    Florence, Tuscany, 50134, Italy

  • Barts

    London, EC1M6BQ, United Kingdom

  • Beijing Cancer Hospital

    Beijing, 100142, China

  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

    Miskolc, 3526, Hungary

  • Bradford Hill Centro de Investigaciones Clinicas

    Recoleta, 8420383, Chile

  • Budapesti Uzsoki Utcai Kórház

    Budapest, 1145, Hungary

  • CENEIT Oncologicos

    Mexico City, 03100, Mexico

  • Cancer Hospital , Chinese Academy of Medical

    Beijing, 100021, China

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511, France

  • Centre Eugene Marquis

    Rennes, 35042, France

  • Centre Georges-François Lecler

    Dijon, 21034, France

  • Centre Hospitalier Universitaire Hassan II

    Fes, 30000, Morocco

  • Centre Hospitalier Universitaire Mohamed VI

    Marrakesh, 40000, Morocco

  • Centre Leon Berard

    Lyon, 69373, France

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

    Montpellier, 34298, France

  • Centro Hospitalar do Porto ? Hospital de Santo António

    Porto, 4099-001, Portugal

  • Centro Medico Dalinde

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

  • Centro de Oncologia de Santa Catarina LTDA

    Chapecó, Santa Catarina, 89812-211, Brazil

  • Christie Hospital NHS Trust

    Manchester, M20 4BX, United Kingdom

  • City Clinical Oncology Dispensary, SPb SBIH CCOD

    Saint Petersburg, Sankt-Peterburg, 198255, Russia

  • Clinica Vespucio

    Santiago, 8241479, Chile

  • Clinical Center of Montenegro

    Podgorica, 81000, Montenegro

  • Clinical Centre Nis, Clinic for Oncology

    Niš, 18000, Serbia

  • Clinical center University of Sarajevo

    Sarajevo, 71000, Bosnia and Herzegovina

  • Clinique specialise Menara

    Marrakesh, 40000, Morocco

  • Ege University Medical Faculty

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

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

    Saint Petersburg, Sankt-Peterburg, DUMMY_VALUE, Russia

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

    Moscow, Moscow Oblast, 115478, Russia

  • Florida Cancer Specialists & Research Institute

    St. Petersburg, Florida, 33705, United States

  • Florida Cancer Specialists - Fort Myers (Broadway)

    Fort Myers, Florida, 33916, United States

  • Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo

    Candiolo, Piedmont, 10060, Italy

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032, China

  • Fujian Medical University Union Hospital

    Fujian, 350001, China

  • Guys and St Thomas NHS Foundation Trust, Guys Hospital

    London, SE1 9RT, United Kingdom

  • Harbin Medical University Cancer Hospital

    Harbin, 150081, China

  • Helsinki University Central Hospital

    Helsinki, 00029, Finland

  • Hospital Araujo Jorge

    Goiânia, Goiás, 74605-070, Brazil

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, 29010, Spain

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007, Spain

  • Hospital Hermanos Ameijeiras

    La Habana, 10300, Cuba

  • Hospital Nossa Senhora da Conceicao

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

  • Hospital Perola Byington

    São Paulo, São Paulo, 01317-000, Brazil

  • Hospital Provincial del Centenario

    Rosario, 2000, Argentina

  • Hospital Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital Sao Vicente de Paulo

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

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital de Cruces

    Bilbao, Vizcaya, 48903, Spain

  • Hospital de Santa Maria

    Lisbon, 1649-035, Portugal

  • Hospital do Cancer de Pernambuco - HCP

    Recife, Pernambuco, 50040-000, Brazil

  • IGR

    Villejuif, 94800, France

  • IRCCS Istituto Oncologico Veneto (IOV)

    Padova, Veneto, 35128, Italy

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031, United States

  • Institut Paoli-Calmettes

    Marseille, 13009, France

  • Institute of Oncology and Radiology of Serbia

    Belgrade, 11000, Serbia

  • Instituto Nacional de Cancerologia

    Distrito Federal, 14080, Mexico

  • Instituto Nacional de Enfermedades Neoplasicas

    Lima, Lima 34, Peru

  • Instituto Nacional de Oncología y Radiología (INOR)

    La Habana, 10400, Cuba

  • Instituto de Oncología de Rosario

    Rosario, S2000KZE, Argentina

  • Instituto de Pesquisa Grupo NotreDame Intermedica

    São Paulo, São Paulo, 01229-010, Brazil

  • Irccs Istituto Europeo Di Oncologia (IEO)

    Milan, Lombardy, 20141, Italy

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

    Naples, Campania, 80131, Italy

  • Jiangsu Province Hospital

    Nanjing, 210036, China

  • Jilin Cancer Hospital

    Changchun, 132013, China

  • Kazakh Scientific Research Institution Of Oncology and Radiology

    Almaty, 050022, Kazakhstan

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

    Essen, 45136, Germany

  • Magee-Woman's Hospital

    Pittsburgh, Pennsylvania, 15213, United States

  • Marmara University Pendik Training and Research Hospital

    Istanbul, 34890, Turkey (Türkiye)

  • Medical Oncology Centre of Rosebank

    Johannesburg, 2196, South Africa

  • Medipol University Medical Faculty

    Istanbul, 34214, Turkey (Türkiye)

  • Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe

    Hanover, 30625, Germany

  • Medizinisches Zentrum für Hämatologie und Onkologie

    München, 80639, Germany

  • Moscow City Oncology Hospital #62

    Moscovskaya Oblast, Moscow Oblast, 143423, Russia

  • Moscow Clinical Scientific Center

    Moscow, Moscow Oblast, 111123, Russia

  • Mount Vernon Cancer Centre

    Northwood, HA6 2RN, United Kingdom

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

    Warsaw, 02-781, Poland

  • National Cancer Centre

    Singapore, 168583, Singapore

  • Nationales Centrum für Tumorerkrankungen (NCT)

    Heidelberg, 69120, Germany

  • Necmettin Erbakan University Meram Medical Faculty

    Konya, 42080, Turkey (Türkiye)

  • Núcleo de Pesquisa São Camilo

    São Paulo, São Paulo, 03102-002, Brazil

  • Oncocentro Serviços Medicos E Hospitalares Ltda

    Fortaleza, Ceará, 60130-241, Brazil

  • Oncology Institute of Vojvodina

    Kamenitz, 21204, Serbia

  • Orszagos Onkologiai Intezet

    Budapest, 1122, Hungary

  • Ospedale Antonio Perrino

    Brindisi, Apulia, 72100, Italy

  • Ospedale San Gerardo

    Monza, Lombardy, 20900, Italy

  • Ospedale San Raffaele S.r.l.

    Milan, Lombardy, 20132, Italy

  • Peking University People's Hospital

    Beijing, 100044, China

  • Private Healthcare Institution Clinical Hospital RZhD Medicine

    Saint Petersburg, Sankt-Peterburg, 195271, Russia

  • Private Oncology Centre

    Pretoria, 0081, South Africa

  • Pécsi Tudományegyetem

    Pécs, 7623, Hungary

  • Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust

    Lancaster, LA1 4RP, United Kingdom

  • Royal Stoke University Hospital

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

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203, United States

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Shanxi Province Cancer Hospital

    Taiyuan, DUMMY_VALUE, China

  • Sir Run Run Shaw Hospital Zhejiang University

    Hangzhou, 310016, China

  • Sun Yat-sen Memorial Hospital

    Guangzhou, 510000, China

  • Szent Margit Hospital

    Budapest, 1032, Hungary

  • Tampere University Hospital

    Tampere, 33520, Finland

  • The Affiliated Hospital of Medical College Qingdao University

    Qingdao, 266003, China

  • The First Affiliated Hospital Of Jinzhou Medical University

    Jinzhou, 121001, China

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

    Xi'an, 710032, China

  • The First Affiliated Hospital, Chongqing Medical University

    Chongqing, 400016, China

  • The Panama Clinic

    Panama City, 32400, Panama

  • The Valley Hospital

    Paramus, New Jersey, 07652, United States

  • Tianjin Cancer Hospital

    Tianjin, 300060, China

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

    Edirne, 22030, Turkey (Türkiye)

  • University Hospital Coventry

    Coventry, CV2 2DX, United Kingdom

  • University Hospital Medical Center Bezanijska kosa

    Belgrade, 11080, Serbia

  • Universitätsklinikum "Carl Gustav Carus"

    Dresden, 01307, Germany

  • Universitätsklinikum Halle (Saale)

    Halle, 06120, Germany

  • Varisano Klinikum Frankfurt Höchst GmbH

    Frankfurt, 65929, Germany

  • Velindre Cancer Centre

    Cardiff, CF14 2TL, United Kingdom

  • Western General Hospital

    Edinburgh, EH4 2XU, United Kingdom

  • Wits Clinical Research

    Johannesburg, 2193, South Africa

  • Zhejiang Cancer Hospital

    Hangzhou, 310022, China

  • the First Affiliated Hospital of Bengbu Medical College

    Anhui, DUMMY_VALUE, China

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