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Triple-Negative Breast CancerPhase 3EL1SSARNCT04148911

A Study of Atezolizumab Plus Nab-Paclitaxel in the Treatment of Unresectable Locally Advanced or Metastatic PD-L1-Positive Triple-Negative Breast Cancer

A Phase 3 study testing Atezolizumab and Nab-Paclitaxel in people with Triple-Negative Breast Cancer, run by Hoffmann-La Roche at 67 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Study MO39874 is an open-label, Phase IIIb, single arm, global study conducted in participants with unresectable locally advanced or metastatic PD-L1-positive Triple-Negative Breast Cancer (TNBC) who have not received chemotherapy for their unresectable locally advanced or metastatic disease. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Triple-Negative Breast Cancer
What is being tested?
Atezolizumab and Nab-Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
184 participants
Where
67 sitesin 13 countries
Study dates
10 Dec 2019to 15 Dec 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Unresectable locally advanced or metastatic, histologically documented TNBC (negative for HER2 and ER and PgR)
  • At least one specimen positive for PD-L1 status as determined by VENTANA PD-L1 SP142 IHC Assay
  • No prior chemotherapy, experimental or targeted systemic therapy for unresectable locally advanced or metastatic TNBC
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  • Life expectancy ≥ 12 weeks
  • Measurable disease, as defined by RECIST v1.1
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  • Adequate haematologic and end-organ function, defined by the following laboratory results obtained within 14 days prior to the initiation of study treatment
  • 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) deoxyribonucleic acid (DNA) test at screening
  • Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV ribonucleic acid (RNA) test at screening
  • Patients with treated asymptomatic central nervous system (CNS) metastases are eligible, provided that all the following criteria are met: (a) The metastases are limited to the supratentorial region or cerebellum (b) No ongoing requirement for corticosteroids as therapy for CNS disease (c) No stereotactic radiation within 7 days or whole-brain radiation or neurosurgical resection within 2 weeks before the start of study treatment (d) Radiographic demonstration of interim stability between the completion of CNS-directed therapy and the screening imaging study.
  • Patients with a history of autoimmune disease (Appendix 2) are allowed if controlled and on stable treatment (i.e., same treatment, same dose) for the last 12 weeks
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in 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 nab-paclitaxel/paclitaxel, whichever is later. In addition, women must refrain from donating eggs during the same time period
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm
  • Women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of study drug

Who cannot join

  • Cancer- Specific 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 the first dose of study treatment (Cycle 1, Day 1).
  • Leptomeningeal carcinomatosis or any symptomatic CNS metastases
  • Uncontrolled symptomatic pleural effusion, pericardial effusion, or ascites
  • Uncontrolled tumour-related pain
  • Uncontrolled hypercalcemia (> 1.5 mmol/L ionized calcium or calcium > 12 mg/dL or corrected serum calcium > ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy.
Show all 29Show fewer
  • Malignancies other than breast cancer within 5 years prior to the first dose of study treatment (Cycle 1, Day 1), with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome
  • General Medical Exclusion Criteria:
  • Pregnancy or lactation
  • Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease
  • Significant cardiovascular disease such as New York Heart Association (NYHA) cardiac disease (Class II or greater), myocardial infarction within 3 months prior to the first dose of study treatment (Cycle 1, Day 1), unstable arrhythmias, or unstable angina
  • Severe infection within 4 weeks prior to the first dose of study treatment (Cycle 1, Day 1), including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia, or any active infection, that in the opinion of the investigator, could impact patient safety.
  • Treatment with oral or IV antibiotics within 2 weeks prior to initiation of study treatment (Cycle 1, Day 1)
  • Major surgical procedure within 28 days prior to the first dose of study treatment (Cycle 1, Day 1), or anticipation of the need for a major surgical procedure during the course of the study (other than diagnostic procedures)
  • Treatment with investigational therapy within 4 weeks prior to Cycle 1, Day 1
  • Known hypersensitivity to nab-paclitaxel or any of the excipients, when nab-paclitaxel is used as a backbone taxane
  • Known hypersensitivity to paclitaxel or any of the excipients, when paclitaxel is used as a backbone taxane
  • Positive human immunodeficiency virus (HIV) test at screening, unless the patient meets all of the following conditions: stable on anti-retroviral therapy, CD4 count ≥200/mL, undetectable viral load
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
  • Prior allogenic 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 CT scan
  • Current treatment with anti-viral therapy for HBV
  • Active tuberculosis
  • Receipt of a live, attenuated vaccine within 4 weeks prior to the first dose of study treatment (Cycle 1, Day 1), or anticipation that such a live, attenuated vaccine will be required during atezolizumab treatment or within 5 months following the final dose of atezolizumab
  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies (including anti-CTLA4 antibodies), except for anti-PD-1 or anti-PD-L1 antibodies.
  • Treatment with systemic immunostimulatory agents (including but not limited to interferons or IL-2) within 4 weeks or five half-lives of the drug (whichever is longer) prior to the first dose of study treatment (Cycle 1, Day 1)
  • Only in patients without autoimmune disease: Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antitumour necrosis factor [TNF] agents) within 2 weeks prior to the first dose of study treatment (Cycle 1, Day 1), or anticipated requirement for systemic immunosuppressive medications during the study

Trial locations and contacts

67 sites in 13 countries.

67 sites in 13 countries

Italy17 sites

  • Azienda Ospedaliera San Giuseppe Moscati

    Avellino, Campania, 83100

  • Fondazione del Piemonte per l?Oncologia (IRCCS)

    Candiolo, Trentino-Alto Adige, 10060

  • Ospedale Cannizzaro, Oncologia

    Catania, Sicily, 95126

  • Azienda Universitaria Magna Grecia

    Catanzaro, Calabria, 88100

  • USL Umbria 1 - Osp. Città di Castello

    Città Di Castello (PG), Umbria, 06012

  • Azienda ospedaliero-universitaria careggi, Sezione di radioterapia del dipartimento di fisiopatolo

    Florence, Tuscany, 50134

  • Irccs Ospedale San Raffaele

    Milan, Lombardy, 20132

  • Istituto Europeo Di Oncologia

    Milan, Lombardy, 20141

  • AULSS3 - Presidio di Mirano

    Mirano (VE), Veneto, 30035

  • Ospedale San Gerardo

    Monza, Lombardy, 20900

  • Fondazione IRCCS Policlinico San Matteo, Oncologia

    Pavia, Lombardy, 27100

  • Azienda Ospedaliero - Universitaria Pisana U.O. Oncologia Medica 2 Universitaria ? Polo Oncologico

    Pisa, Tuscany, 56126

  • Nuovo Ospedale di Prato S. Stefano - Azienda USL Toscana Centro

    Prato, Tuscany, 59100

  • Policlinico Universitario Agostino Gemelli

    Rome, Lazio, 00168

  • Ospedale Civile

    Sassari, Sardinia, 07100

  • Clinica Oncologica-Ospedali Riuniti Ancona

    Torrette, Tuscany, 60020

  • Ospedale Santa Chiara

    Trento, Trentino-Alto Adige, 38100

Other trials in Italy

Spain12 sites

  • Hospital de Basurto

    Bilbao, Vizcaya, 48013

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • Hospital Universitario San Cecilio

    Granada, 18003

  • Hospital Universitari Arnau de Vilanova de Lleida

    Lleida, 25198

  • Hospital Lucus Augusti

    Lugo, 27003

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital General Universitario J.M Morales Meseguer

    Murcia, 30008

  • Hospital Univ. Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Corporacio Sanitaria Parc Tauli

    Sabadell, Barcelona, 08208

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007

  • Hospital Alvaro Cunqueiro

    Vigo, Pontevedra, 36312

Other trials in Spain

France6 sites

  • Institut de Cancérologie de Bourgogne

    Dijon, 21000

  • Hôpital Franco-Britannique- Fondation Cognacq-Jay

    Levallois-Perret, 92300

  • Centre Leon Berard

    Lyon, 69373

  • Institut de cancerologie du Gard

    Nîmes, 30029

  • Clinique Onco Des Dentellieres

    Valenciennes, 59300

  • Departement Medecine

    Villejuif, 94805

Other trials in France

Portugal6 sites

  • Hospital Garcia de Orta

    Almada, 2801-951

  • IPO de Coimbra

    Coimbra, 3000-075

  • IPO de Lisboa

    Lisbon, 1099-023

  • Hospital de S. Francisco Xavier

    Lisbon, 1495-005

  • Hospital Cuf Descobertas

    Lisbon, 1998-018

  • IPO do Porto

    Porto, 4200-072

Other trials in Portugal

Hungary5 sites

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Bács-Kiskun Vármegyei Oktatókórház

    Kecskemét, 6000

  • B-A-Z Vármegyei Központi Kórház és Egyetemi Oktatókórház

    Miskolc, 3526

  • Komarom-Eszergom Varmegyei Szent Borbala Korhaz

    Tatabánya, 2800

  • Zala Vármegyei Szent Rafael Kórház

    Zalaegerszeg, 8900

Other trials in Hungary

Poland4 sites

  • Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny

    Brzozów, 36-200

  • Szpital Wojewódzki im. Miko?aja Kopernika

    Koszalin, 75-581

  • Ars Medical Sp. z o. o.

    Pi?a, 64-920

  • MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie

    Rzeszów, 35-021

Other trials in Poland

Argentina3 sites

  • CEMIC

    Buenos Aires, C1431FWN

  • Sanatorio de la Mujer

    Rosario, S2000ORE

  • Organizacion Medica de Investigacion

    San Nicolás, C1015ABO

Other trials in Argentina

Czechia3 sites

  • Nemocnice AGEL Novy Jicin a.s.

    Nový Jičín, 741 01

  • Fakultni Poliklinika Vseobecne Fakultni Niemocnice

    Prague, 128 08

  • Nemocnice na Bulovce

    Prague, 180 81

Other trials in Czechia

Romania3 sites

  • Prof. Dr. I. Chiricuta Institute of Oncology

    Cluj-Napoca, 400015

  • Centrul de Oncologie Sfantul Nectarie

    Craiova, 200542

  • Centrul de Radioterapie AMETHYST

    Floreşti, 407280

Other trials in Romania

Chile2 sites

  • Instituto de Radiomedicina, IRAM

    Santiago, 7630370

  • Pontificia Universidad Catolica de Chile

    Santiago

Other trials in Chile

Mexico2 sites

  • Instituto Nacional de Cancerologia

    Distrito Federal, 14080

  • Hospital de Oncología Siglo XXI

    Mexico City, Mexico CITY (federal District), 06720

Other trials in Mexico

Peru2 sites

  • Instituto Nacional de Enfermedades Neoplasicas

    Lima, 15038

  • Hospital Nacional Cayetano Heredia

    Lima, 31

Other trials in Peru

Slovenia2 sites

  • Institute of Oncology Ljubljana

    Ljubljana, 1000

  • Univerzitetni klini?ni center Maribor

    Maribor, 2000

Other trials in Slovenia

About this study

Official title: An Open-Label, Phase IIIb, Single Arm, Multicenter Safety Study of Atezolizumab (Tecentriq) Plus Nab-Paclitaxel in the Treatment of Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer

Study MO39874 is an open-label, Phase IIIb, single arm, global study conducted in participants with unresectable locally advanced or metastatic PD-L1-positive Triple-Negative Breast Cancer (TNBC) who have not received chemotherapy for their unresectable locally advanced or metastatic disease.

Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    Also called Tecentriq

    Atezolizumab will be administered at a dose of 840 mg via IV infusion on Days 1 and 15 of every 28-day cycle. Day 15: Atezolizumab may be administered on Days 15-18 of each cycle.

  • Nab-PaclitaxelDrug

    Also called Abraxane

    Nab-Paclitaxel will be administered at the 100 mg/m2 dose via IV infusion on Days 1, 8, and 15 of every 28-day cycle. Day 8: Nab-paclitaxel may be administered on Days 8-11 of each cycle. Day 15: Nab-paclitaxel may be administered on Days 15-18 of each cycle, on the same day with the atezolizumab infusion.

Study groups in NCT04148911
Study groupRoleWhat they receive
Atezolizumab plus Nab-PaclitaxelExperimentalParticipants will receive Atezolizumab via intravenous (IV) infusion on Days 1 and 15 of every 28-day cycle in combination with Nab-Paclitaxel on Days 1, 8, and 15 (individually selected by the investigator) until disease progression, or unacceptable toxicity, additionally until loss of clinical benefit as determined by the investigator or participant decision to discontinue treatment.
Receives: Drug: Atezolizumab; Drug: Nab-Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Treatment-emergent Grade ≥3 Adverse Events (AEs)

    AE=untoward medical occurrence in participant administered a pharmaceutical product, regardless of causal attribution. AE=any unfavorable \& unintended sign, symptom/disease temporally associated with the use of pharmaceutical product, whether/not considered related to it. Severity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0). Grade 1=Mild; asymptomatic/mild symptoms; clinical/diagnostic observations only; or intervention not indicated; Grade 2=Moderate; minimal, local/non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living; Grade 3=Severe/medically significant, but not immediately life-threatening; hospitalization/prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living; Grade 4=Life-threatening consequences/urgent intervention indicated; Grade 5=Death related to AE. Percentages have been rounded off.

    Measured: Up to 60 months

  2. Percentage of Participants With Treatment-emergent Grade ≥2 Immune-mediated AEs (imAEs)

    AE=any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. AE=any unfavorable and unintended sign, symptom/disease temporally associated with the use of a pharmaceutical product, whether/not considered related to it. Severity was graded according to NCI CTCAE v5.0. Grade 1=Mild; asymptomatic/mild symptoms; clinical/diagnostic observations only; or intervention not indicated; Grade 2=Moderate; minimal, local/non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living (ADL); Grade 3=Severe/medically significant, but not immediately life-threatening; hospitalization/prolongation of hospitalization indicated; disabling; or limiting self-care ADL; Grade 4=Life-threatening consequences/urgent intervention indicated; Grade 5=Death related to AE. imAEs are events that resemble autoimmune diseases and are known side effects of immune checkpoint inhibitors.

    Measured: Up to 60 months

Secondary outcomes (6)

  1. Percentage of Participants With All Treatment-emergent AEs

    An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the PP. Percentages have been rounded off.

    Measured: Up to 60 months

  2. Percentage of Participants With All Treatment-emergent Serious Adverse Events (SAEs)

    An AE was any untoward medical occurrence in a participant administered a PP and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the PP. SAEs were defined as any AE that fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/ birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here. Percentages have been rounded off.

    Measured: Up to 60 months

  3. Overall Survival (OS) in Safety-evaluable Population

    OS was defined as time from initiation of study treatment to death from any cause. OS was estimated using Kaplan-Meier (K-M) method.

    Measured: Up to 60 months

  4. OS in PD-L1-positive Population

    OS was defined as time from initiation of study treatment to death from any cause. OS was estimated using K-M method.

    Measured: Up to 60 months

  5. Progression Free Survival (PFS) in Safety-evaluable Population

    PFS was defined as the time from initiation of study treatment 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), and must also demonstrate an absolute increase of ≥ 5 millimeters (mm). PFS was estimated using K-M method.

    Measured: Up to 60 months

  6. PFS in PD-L1-positive Population

    PFS was defined as the time from initiation of study treatment 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), and must also demonstrate an absolute increase of ≥ 5 mm. PFS was estimated using K-M method.

    Measured: Up to 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2019
  2. Study start10 Dec 2019
  3. Primary completion15 Dec 2024
  4. Study completion15 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is an open-label (non-blinded), single arm safety study in which all participants will receive atezolizumab in combination with nab-paclitaxel.
Masking
None (open label)
Enrolment
184 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04148911
Sponsor's protocol ID
MO39874
Other IDs
2019-002488-91, 2019
Acronym
EL1SSAR
Status last verified
Dec 2025
First submitted
31 Oct 2019
Last updated
26 Dec 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atezolizumab and Nab-Paclitaxel in people with Triple-Negative Breast Cancer, run by Hoffmann-La Roche at 67 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in Italy, Spain, France, Portugal, Hungary and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Treatment-emergent Grade ≥3 Adverse Events (AEs) (time frame: Up to 60 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04148911.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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