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

NCT04148911 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: MO398742019-002488-91
• Study Type: interventional
• Target: 184
• Locations: 13 countries
• Sites: 67

Brief 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.

Conditions

Triple-Negative Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to 60 months

• 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.

  Up to 60 months

Secondary Outcomes (6)

• Percentage of Participants With All Treatment-emergent AEs

  Up to 60 months

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

  Up to 60 months

• Overall Survival (OS) in Safety-evaluable Population

  Up to 60 months

• OS in PD-L1-positive Population

  Up to 60 months

• Progression Free Survival (PFS) in Safety-evaluable Population

  Up to 60 months

Study Arms (1)

Atezolizumab plus Nab-Paclitaxel

EXPERIMENTAL

Participants 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.

Drug: Atezolizumab; Drug: Nab-Paclitaxel

Interventions

Atezolizumab DRUG

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.

Also known as: Tecentriq

Atezolizumab plus Nab-Paclitaxel

Nab-Paclitaxel DRUG

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.

Also known as: Abraxane

Atezolizumab plus Nab-Paclitaxel

Eligibility Criteria

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

You may qualify if:

• 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
• 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

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 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.
• 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
• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (67)

CEMIC

Buenos Aires, C1431FWN, Argentina

Location

Sanatorio de la Mujer

Rosario, S2000ORE, Argentina

Location

Organizacion Medica de Investigacion

San Nicolás, C1015ABO, Argentina

Location

Instituto de Radiomedicina, IRAM

Santiago, 7630370, Chile

Location

Pontificia Universidad Catolica de Chile

Santiago, Chile

Location

Nemocnice AGEL Novy Jicin a.s.

Nový Jičín, 741 01, Czechia

Location

Fakultni Poliklinika Vseobecne Fakultni Niemocnice

Prague, 128 08, Czechia

Location

Nemocnice na Bulovce

Prague, 180 81, Czechia

Location

Institut de Cancérologie de Bourgogne

Dijon, 21000, France

Location

Hôpital Franco-Britannique- Fondation Cognacq-Jay

Levallois-Perret, 92300, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Institut de cancerologie du Gard

Nîmes, 30029, France

Location

Clinique Onco Des Dentellieres

Valenciennes, 59300, France

Location

Departement Medecine

Villejuif, 94805, France

Location

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032, Hungary

Location

Bács-Kiskun Vármegyei Oktatókórház

Kecskemét, 6000, Hungary

Location

B-A-Z Vármegyei Központi Kórház és Egyetemi Oktatókórház

Miskolc, 3526, Hungary

Location

Komarom-Eszergom Varmegyei Szent Borbala Korhaz

Tatabánya, 2800, Hungary

Location

Zala Vármegyei Szent Rafael Kórház

Zalaegerszeg, 8900, Hungary

Location

Azienda Universitaria Magna Grecia

Catanzaro, Calabria, 88100, Italy

Location

Azienda Ospedaliera San Giuseppe Moscati

Avellino, Campania, 83100, Italy

Location

Policlinico Universitario Agostino Gemelli

Rome, Lazio, 00168, Italy

Location

Irccs Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

Location

Istituto Europeo Di Oncologia

Milan, Lombardy, 20141, Italy

Location

Ospedale San Gerardo

Monza, Lombardy, 20900, Italy

Location

Fondazione IRCCS Policlinico San Matteo, Oncologia

Pavia, Lombardy, 27100, Italy

Location

Ospedale Civile

Sassari, Sardinia, 07100, Italy

Location

Ospedale Cannizzaro, Oncologia

Catania, Sicily, 95126, Italy

Location

Fondazione del Piemonte per l?Oncologia (IRCCS)

Candiolo, Trentino-Alto Adige, 10060, Italy

Location

Ospedale Santa Chiara

Trento, Trentino-Alto Adige, 38100, Italy

Location

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

Florence, Tuscany, 50134, Italy

Location

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

Pisa, Tuscany, 56126, Italy

Location

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

Prato, Tuscany, 59100, Italy

Location

Clinica Oncologica-Ospedali Riuniti Ancona

Torrette, Tuscany, 60020, Italy

Location

USL Umbria 1 - Osp. Città di Castello

Città Di Castello (PG), Umbria, 06012, Italy

Location

AULSS3 - Presidio di Mirano

Mirano (VE), Veneto, 30035, Italy

Location

Hospital de Oncología Siglo XXI

Mexico City, Mexico CITY (federal District), 06720, Mexico

Location

Instituto Nacional de Cancerologia

Distrito Federal, 14080, Mexico

Location

Instituto Nacional de Enfermedades Neoplasicas

Lima, 15038, Peru

Location

Hospital Nacional Cayetano Heredia

Lima, 31, Peru

Location

Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny

Brzozów, 36-200, Poland

Location

Szpital Wojewódzki im. Miko?aja Kopernika

Koszalin, 75-581, Poland

Location

Ars Medical Sp. z o. o.

Pi?a, 64-920, Poland

Location

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

Rzeszów, 35-021, Poland

Location

Hospital Garcia de Orta

Almada, 2801-951, Portugal

Location

IPO de Coimbra

Coimbra, 3000-075, Portugal

Location

IPO de Lisboa

Lisbon, 1099-023, Portugal

Location

Hospital de S. Francisco Xavier

Lisbon, 1495-005, Portugal

Location

Hospital Cuf Descobertas

Lisbon, 1998-018, Portugal

Location

IPO do Porto

Porto, 4200-072, Portugal

Location

Prof. Dr. I. Chiricuta Institute of Oncology

Cluj-Napoca, 400015, Romania

Location

Centrul de Oncologie Sfantul Nectarie

Craiova, 200542, Romania

Location

Centrul de Radioterapie AMETHYST

Floreşti, 407280, Romania

Location

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

Univerzitetni klini?ni center Maribor

Maribor, 2000, Slovenia

Location

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

Location

Corporacio Sanitaria Parc Tauli

Sabadell, Barcelona, 08208, Spain

Location

Hospital Alvaro Cunqueiro

Vigo, Pontevedra, 36312, Spain

Location

Hospital Univ. Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

Location

Hospital de Basurto

Bilbao, Vizcaya, 48013, Spain

Location

Hospital Universitario San Cecilio

Granada, 18003, Spain

Location

Hospital Universitari Arnau de Vilanova de Lleida

Lleida, 25198, Spain

Location

Hospital Lucus Augusti

Lugo, 27003, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Clinico Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital General Universitario J.M Morales Meseguer

Murcia, 30008, Spain

Location

Hospital Clinico Universitario de Salamanca

Salamanca, 37007, Spain

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

atezolizumab; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

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: NA
• Masking: NONE
• Masking Details: Open label, non-blinded
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an open-label (non-blinded), single arm safety study in which all participants will receive atezolizumab in combination with nab-paclitaxel.

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 4, 2019
• Study Start: December 10, 2019
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: December 26, 2025
• Results First Posted: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

RO (3); PL (4); FR (6); HU (5); ES (12); CZ (3); CL (2); PE (2); IT (17); ME (2); PT (6); AR (3); SL (2)