Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug combo tested for tough breast cancer: safety results in

NCT ID NCT04148911

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested the safety of combining the immunotherapy drug atezolizumab with the chemotherapy nab-paclitaxel in 184 people with advanced triple-negative breast cancer that had spread. Participants had not received prior chemotherapy for their advanced disease. The main goal was to track serious side effects and immune-related reactions.

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

184 people

The number who actually took part.

Started

Dec 2019

Finished

Dec 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: * 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 Exclusion Criteria: 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. * 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 Exclusion Criteria Related to Atezolizumab: * 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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Triple negative breast cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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 cancer

Contacts and locations

Locations

  • AULSS3 - Presidio di Mirano

    Mirano (VE), Veneto, 30035, Italy

  • Ars Medical Sp. z o. o.

    Pi?a, 64-920, Poland

  • Azienda Ospedaliera San Giuseppe Moscati

    Avellino, Campania, 83100, Italy

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

    Pisa, Tuscany, 56126, Italy

  • Azienda Universitaria Magna Grecia

    Catanzaro, Calabria, 88100, Italy

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

    Florence, Tuscany, 50134, Italy

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

    Miskolc, 3526, Hungary

  • Bács-Kiskun Vármegyei Oktatókórház

    Kecskemét, 6000, Hungary

  • CEMIC

    Buenos Aires, C1431FWN, Argentina

  • Centre Leon Berard

    Lyon, 69373, France

  • Centrul de Oncologie Sfantul Nectarie

    Craiova, 200542, Romania

  • Centrul de Radioterapie AMETHYST

    Floreşti, 407280, Romania

  • Clinica Oncologica-Ospedali Riuniti Ancona

    Torrette, Tuscany, 60020, Italy

  • Clinique Onco Des Dentellieres

    Valenciennes, 59300, France

  • Corporacio Sanitaria Parc Tauli

    Sabadell, Barcelona, 08208, Spain

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032, Hungary

  • Departement Medecine

    Villejuif, 94805, France

  • Fakultni Poliklinika Vseobecne Fakultni Niemocnice

    Prague, 128 08, Czechia

  • Fondazione IRCCS Policlinico San Matteo, Oncologia

    Pavia, Lombardy, 27100, Italy

  • Fondazione del Piemonte per l?Oncologia (IRCCS)

    Candiolo, Trentino-Alto Adige, 10060, Italy

  • Hospital Alvaro Cunqueiro

    Vigo, Pontevedra, 36312, Spain

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, 29010, Spain

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital Cuf Descobertas

    Lisbon, 1998-018, Portugal

  • Hospital Garcia de Orta

    Almada, 2801-951, Portugal

  • Hospital General Universitario J.M Morales Meseguer

    Murcia, 30008, Spain

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203, Spain

  • Hospital Lucus Augusti

    Lugo, 27003, Spain

  • Hospital Nacional Cayetano Heredia

    Lima, 31, Peru

  • Hospital Univ. Central de Asturias

    Oviedo, Principality of Asturias, 33011, Spain

  • Hospital Universitari Arnau de Vilanova de Lleida

    Lleida, 25198, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario San Cecilio

    Granada, 18003, Spain

  • Hospital de Basurto

    Bilbao, Vizcaya, 48013, Spain

  • Hospital de Oncología Siglo XXI

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

  • Hospital de S. Francisco Xavier

    Lisbon, 1495-005, Portugal

  • Hôpital Franco-Britannique- Fondation Cognacq-Jay

    Levallois-Perret, 92300, France

  • IPO de Coimbra

    Coimbra, 3000-075, Portugal

  • IPO de Lisboa

    Lisbon, 1099-023, Portugal

  • IPO do Porto

    Porto, 4200-072, Portugal

  • Institut de Cancérologie de Bourgogne

    Dijon, 21000, France

  • Institut de cancerologie du Gard

    Nîmes, 30029, France

  • Institute of Oncology Ljubljana

    Ljubljana, 1000, Slovenia

  • Instituto Nacional de Cancerologia

    Distrito Federal, 14080, Mexico

  • Instituto Nacional de Enfermedades Neoplasicas

    Lima, 15038, Peru

  • Instituto de Radiomedicina, IRAM

    Santiago, 7630370, Chile

  • Irccs Ospedale San Raffaele

    Milan, Lombardy, 20132, Italy

  • Istituto Europeo Di Oncologia

    Milan, Lombardy, 20141, Italy

  • Komarom-Eszergom Varmegyei Szent Borbala Korhaz

    Tatabánya, 2800, Hungary

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

    Rzeszów, 35-021, Poland

  • Nemocnice AGEL Novy Jicin a.s.

    Nový Jičín, 741 01, Czechia

  • Nemocnice na Bulovce

    Prague, 180 81, Czechia

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

    Prato, Tuscany, 59100, Italy

  • Organizacion Medica de Investigacion

    San Nicolás, C1015ABO, Argentina

  • Ospedale Cannizzaro, Oncologia

    Catania, Sicily, 95126, Italy

  • Ospedale Civile

    Sassari, Sardinia, 07100, Italy

  • Ospedale San Gerardo

    Monza, Lombardy, 20900, Italy

  • Ospedale Santa Chiara

    Trento, Trentino-Alto Adige, 38100, Italy

  • Policlinico Universitario Agostino Gemelli

    Rome, Lazio, 00168, Italy

  • Pontificia Universidad Catolica de Chile

    Santiago, Chile

  • Prof. Dr. I. Chiricuta Institute of Oncology

    Cluj-Napoca, 400015, Romania

  • Sanatorio de la Mujer

    Rosario, S2000ORE, Argentina

  • Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny

    Brzozów, 36-200, Poland

  • Szpital Wojewódzki im. Miko?aja Kopernika

    Koszalin, 75-581, Poland

  • USL Umbria 1 - Osp. Città di Castello

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

  • Univerzitetni klini?ni center Maribor

    Maribor, 2000, Slovenia

  • Zala Vármegyei Szent Rafael Kórház

    Zalaegerszeg, 8900, Hungary

More trials for these conditions

Other studies related to the condition(s) this trial covers.