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Triple-negative Breast CancerPhase 3IMpassion031NCT03197935

A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer

A Phase 3 study testing Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody, Nab-paclitaxel and Doxorubicin in people with Triple-negative Breast Cancer, run by Hoffmann-La Roche at 68 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

This is a global Phase III, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab (anti-programmed death-ligand 1 [anti-PD-L1] antibody) and nab-paclitaxel followed by doxorubicin and cyclophosphamide (nab-pac-AC), or placebo and… 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 (MPDL3280A), an engineered anti-PDL1 antibody, Nab-paclitaxel and Doxorubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
333 participants
Where
68 sitesin 13 countries
Study dates
24 Jul 2017to 28 Sep 2022
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

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Histologically documented TNBC (negative human epidermal growth factor receptor 2 [HER2], estrogen receptor [ER], and progesterone receptor [PgR] status)
  • Confirmed tumor programmed death-ligand 1 (PD-L1) evaluation as documented through central testing of a representative tumor tissue specimen
  • Primary breast tumor size of greater than (>) 2 centimeters (cm) by at least one radiographic or clinical measurement
  • Stage at presentation: cT2-cT4, cN0-cN3, cM0
  • Participant agreement to undergo appropriate surgical management including axillary lymph node surgery and partial or total mastectomy after completion of neoadjuvant treatment
Show all 12Show fewer
  • Baseline left ventricular ejection fraction (LVEF) greater than or equal to (>=) 53 percent (%) measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans
  • Adequate hematologic and end-organ function
  • Representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen in paraffin blocks (preferred) or at least 20 unstained slides, with an associated pathology report documenting ER, PgR, and HER2 negativity
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs
  • 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 or have undergone a sterilization procedure must have a negative serum pregnancy test result within 14 days prior to initiation of study drug

Who cannot join

  • Prior history of invasive breast cancer
  • Stage 4 (metastatic) breast cancer
  • Prior systemic therapy for treatment and prevention of breast cancer
  • Previous therapy with anthracyclines or taxanes for any malignancy
  • History of ductal carcinoma in situ (DCIS), except for participants treated exclusively with mastectomy >5 years prior to diagnosis of current breast cancer
  • History of pleomorphic lobular carcinoma in situ (LCIS), except for participants surgically managed >5 years prior to diagnosis of current breast cancer
Show all 30Show fewer
  • Bilateral breast cancer
  • Undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes
  • Axillary lymph node dissection prior to initiation of neoadjuvant therapy
  • History of other malignancy within 5 years prior to screening, with the exception of those with a negligible risk of metastasis or death
  • Cardiopulmonary dysfunction
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells
  • Known allergy or hypersensitivity to the components of the formulations of atezolizumab, nab-paclitaxel, cyclophosphamide, or doxorubicin, filgrastim or pegfilgrastim
  • Active or history of autoimmune disease or immune deficiency diseases except history of autoimmune-related hypothyroidism, controlled Type 1 diabetes mellitus, and dermatologic manifestations of eczema, psoriasis, lichen simplex chronicus, or vitiligo (e.g., participants with psoriatic arthritis are excluded)
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
  • Positive human immunodeficiency virus (HIV) test at screening
  • Active hepatitis B and hepatitis C virus infection
  • Active tuberculosis
  • Severe infections within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
  • Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment, except prophylactic antibiotics
  • Major surgical procedure within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during the course of the study
  • Prior allogeneic stem cell or solid organ transplantation
  • Administration of a live attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation of need for such a vaccine during the study
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications
  • Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint-blockade therapies, including anti-cluster of differentiation 40 (anti-CD40), anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies
  • Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to initiation of study treatment
  • Treatment with systemic immunosuppressive medications within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressive medications during the study
  • History of cerebrovascular accident within 12 months prior to randomization
  • Pregnant or lactating, or intending to become pregnant during the study

Trial locations and contacts

68 sites in 13 countries.

68 sites in 13 countries

Germany13 sites

  • Hochwaldkrankenhaus

    Bad Nauheim, 61231

  • Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)

    Berlin, 10367

  • Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters

    Berlin, 13581

  • Onkologische Schwerpunktpraxis Bielefeld

    Bielefeld, 33604

  • Luisenkrankenhaus GmbH & Co. KG., Brustzentrum

    Düsseldorf, 40235

  • Evangelische Kliniken Gelsenkirchen GmbH; Brustzentrum

    Gelsenkirchen, 45879

  • Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem

    Hamburg, 20357

  • Diakovere Henriettenstift, Frauenklinik

    Hanover, 30559

  • Dres. Andreas Köhler und Roswitha Fuchs

    Langen, 63225

  • St. Elisabeth-Krankenhaus, Senologie/Brustzentrum

    Leipzig, 04277

  • Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt

    München, 80336

  • Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe

    Münster, 48149

  • Medizinisches Versorgungszentrum am Klinikum Oldenburg GmbH

    Oldenburg, 26133

Other trials in Germany

United States12 sites

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

    Carrollton, Georgia, 30117

  • Tennessee Oncology - Chattanooga; Tennessee Oncology - East Third Street

    Chattanooga, Tennessee, 37404

  • The Center for Cancer and Blood Disorders - Fort Worth

    Fort Worth, Texas, 76104

  • HCA Midwest Division

    Kansas City, Missouri, 64132

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • Vanderbilt Breast Center at One Hundred Oaks

    Nashville, Tennessee, 37204

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Norwalk Hospital

    Norwalk, Connecticut, 06856

  • Stanford University Medical Center

    Palo Alto, California, 94304

  • The Valley Hospital; Valley Medical Group

    Paramus, New Jersey, 07652

  • Cancer Care Northwest

    Spokane, Washington, 99204

Other trials in United States

Japan9 sites

  • Aichi Cancer Center Hospital

    Aichi, 464-8681

  • National Hospital Organization Shikoku Cancer Center

    Ehime, 791-0280

  • Fukushima Medical University Hospital

    Fukushima, 960-1295

  • Hiroshima City Hiroshima Citizens Hospital; Breast Surgery

    Hiroshima, 730-8518

  • Kanagawa Cancer Center

    Kanagawa, 241-8515

  • Tokai University Hospital

    Kanagawa, 259-1193

  • National Hospital Organization Osaka National Hospital; Breast Surgery

    Osaka, 540-0006

  • St. Luke's Internat. Hospital, Breast Surgical Oncology

    Tokyo, 104-8560

  • The Cancer Inst. Hosp. of JFCR; Breast Oncology Center

    Tokyo, 135-8550

Other trials in Japan

Brazil8 sites

  • Iop Instituto de Oncologia Do Parana

    Curitiba, Paraná, 80530-010

  • Hospital Araujo Jorge; Departamento de Ginecologia E Mama

    Goiânia, Goiás, 74605-070

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Clinicas Oncologicas Integradas - COI

    Rio de Janeiro, Rio de Janeiro, 22290-160

  • Santa Casa de Misericordia de Salvador

    Salvador, Estado de Bahia, 40050-410

  • Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

    São Paulo, São Paulo, 01317-001

  • CETUS Hospital Dia Oncologia

    Uberaba, Minas Gerais, 38082-049

Other trials in Brazil

Belgium4 sites

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • UZ Leuven Gasthuisberg

    Leuven, 3000

  • Clinique Ste-Elisabeth

    Namur, 5000

  • Sint Augustinus Wilrijk

    Wilrijk, 2610

Other trials in Belgium

South Korea4 sites

  • National Cancer Center

    Goyang-si, 10408

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

Canada3 sites

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Hopital Sacre-Coeur Research Centre

    Montreal, Quebec, H4J 1C5

  • Hopital du Saint Sacrement

    Québec, Quebec, G1S 4L8

Other trials in Canada

Italy3 sites

  • Irccs Ospedale San Raffaele

    Milan, Lombardy, 20132

  • Ospedale San Gerardo

    Monza, Lombardy, 20900

  • Azienda ULSS 8 Berica; Oncologia Medica - Ospedlae di Vicenza

    Vicenza, Veneto, 36100

Other trials in Italy

Taiwan3 sites

  • VETERANS GENERAL HOSPITAL; Department of General Surgery

    Taipei, 00112

  • Mackay Memorial Hospital; Dept of Surgery

    Taipei, 104

  • Chang Gung Medical Foundation Linkou Branch

    Taoyuan City, 333

Other trials in Taiwan

United Kingdom3 sites

  • Leicester Royal Infirmary

    Leicester, LE1 5WW

  • Barts & London School of Med; Medical Oncology

    London, EC1A 7BE

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN

Other trials in United Kingdom

Australia2 sites

  • Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit

    Bull Creek, Western Australia, 6149

  • Monash Medical Centre

    Clayton, Victoria, 3168

Other trials in Australia

Poland2 sites

  • Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr

    Warsaw, 02-781

  • Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii; Oddz. Onkologii Klin. i Chemioterapii

    Wroc?aw, 53-413

Other trials in Poland

Spain2 sites

  • Hospital Universitario 12 de Octubre; Servicio de Oncologia

    Madrid, 28041

  • Hospital Universitario Virgen del Rocio; Servicio de Oncologia

    Seville, 41013

Other trials in Spain

About this study

Official title: A Phase III Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Neoadjuvant Anthracycline/Nab-Paclitaxel-Based Chemotherapy Compared With Placebo and Chemotherapy in Patients With Primary Invasive Triple-Negative Breast Cancer

This is a global Phase III, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab (anti-programmed death-ligand 1 [anti-PD-L1] antibody) and nab-paclitaxel followed by doxorubicin and cyclophosphamide (nab-pac-AC), or placebo and nab-pac-AC in participants eligible for surgery with initial clinically assessed triple-negative breast cancer (TNBC).

Being tested
Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody, Placebo, Nab-paclitaxel, Doxorubicin, Cyclophosphamide
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.

  • Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibodyDrug

    Atezolizumab was administered as per schedule described in respective arm.

  • PlaceboDrug

    Placebo matched to atezolizumab was administered as per schedule described in respective arm.

  • Nab-paclitaxelDrug

    Nab-paclitaxel was administered as per schedule described in the arms.

  • DoxorubicinDrug

    Doxorubicin was administered as per schedule described in the arms.

  • CyclophosphamideDrug

    Cyclophosphamide was administered as per schedule described in the arms.

  • FilgrastimDrug

    Filgrastim was administered according to local prescribing information as determined by the Investigator for 4 doses after completion of initial 12 weeks.

  • PegfilgrastimDrug

    Pegfilgrastim was administered according to local prescribing information as determined by the Investigator for 4 doses after completion of initial 12 weeks.

Study groups in NCT03197935
Study groupRoleWhat they receive
Atezolizumab and ChemotherapyExperimentalParticipants received atezolizumab (840 milligrams [mg]) via intravenous (IV) infusion every 2 weeks in combination with nab-paclitaxel (125 milligrams per square meter [mg/m^2]) via IV infusion every week for 12 weeks, followed by atezolizumab (840 mg) every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants continued to receive unblinded atezolizumab post-surgery at a fixed dose of 1200 mg by IV infusion every 3 weeks for 11 doses, for a total of approximately 12 months of atezolizumab therapy.
Receives: Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody; Drug: Nab-paclitaxel; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Filgrastim; Drug: Pegfilgrastim
Placebo and ChemotherapyPlacebo comparatorParticipants received placebo matched to atezolizumab via IV infusion every 2 weeks in combination with nab-paclitaxel (125 mg/m^2) via IV infusion every week for 12 weeks, followed by placebo matched to atezolizumab every 2 weeks in combination with doxorubicin (60 mg/m^2) and cyclophosphamide (600 mg/m^2) every 2 weeks via IV infusions with filgrastim/pegfilgrastim support for 4 doses. Participants will be unblinded post-surgery and will continue to be followed.
Receives: Drug: Placebo; Drug: Nab-paclitaxel; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Filgrastim; Drug: Pegfilgrastim

What is being measured

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

  1. Number of Participants With Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population

    Number of participants with Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population. pCR is defined as eradication of invasive tumor from both breast and lymph nodes (ypT0/is ypN0). pCR was evaluated for each participant after neoadjuvant study treatment and surgery. Participants whose pCR assessment was missing will be counted as not achieving a pCR.

    Measured: After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020

  2. Number of Participants With pCR in Subpopulation With PD-L1-Positive Tumor Status (Tumor-infiltrating Immune Cell [IC] 1/2/3) Using AJCC Staging System

    Number of participants with Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in the subpopulation with programmed death-ligand1 (PD-L1)-positive tumor status(tumor-infiltrating immune cell [IC] IC1/2/3) . pCR is defined as eradication of invasive tumor from both breast and lymph nodes (ypT0/is ypN0). pCR was evaluated for each participant after neoadjuvant study treatment and surgery. Participants whose pCR assessment was missing will be counted as not achieving a pCR.

    Measured: After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020

Secondary outcomes (12)

  1. Event-Free Survival (EFS) in All Participants

    Event-free survival (EFS) defined as the time from randomization to the first documented occurrence of disease recurrence, disease progression, or death from any cause in all participants. Recurrent disease includes local, regional, or distant recurrence and contralateral breast cancer. Ipsilateral or contralateral in situ disease and second primary non-breast cancers (including in situ carcinomas and non-melanoma skin cancers) will not be counted as progressive disease or recurrent disease.

    Measured: From randomization and up to study final analysis data cut off on 28 September 2022.

  2. Event-Free Survival (EFS) in Subpopulation With PD-L1-Postive Tumor Status

    Event-free survival (EFS) defined as the time from randomization to the first documented occurrence of disease recurrence, disease progression, or death from any cause in the subpopulation with PD-L1-positive tumor status. Recurrent disease includes local, regional, or distant recurrence and contralateral breast cancer. Ipsilateral or contralateral in situ disease and second primary non-breast cancers (including in situ carcinomas and non-melanoma skin cancers) will not be counted as progressive disease or recurrent disease.

    Measured: From randomization and up to study final analysis data cut off on 28 September 2022.

  3. Disease-Free Survival (DFS) in All Participants Who Undergo Surgery

    Disease-free survival (DFS) defined as the time from surgery to the first documented disease recurrence or death from any cause, whichever occurs first. DFS is analyzed with the use of the same methodology as specified for EFS for all participants.

    Measured: From surgery and up to study final analysis data cut off on 28 September 2022.

  4. Disease-Free Survival (DFS) in Subpopulation of Participants With PD-L1-Positive Tumor Status Who Undergo Surgery

    Disease-free survival (DFS) defined as the time from surgery to the first documented disease recurrence or death from any cause, whichever occurs first. DFS is analyzed with the use of the same methodology as specified for EFS for the subpopulation of participants with PD-L1-positive tumor status.

    Measured: From surgery and up to study final analysis data cut off on 28 September 2022.

  5. Overall Survival (OS) in All Participants

    Overall survival (OS) defined as the time from randomization to the date of death from any cause in all participants.

    Measured: From randomization and up to study final analysis data cut off on 28 September 2022.

  6. Overall Survival (OS) in Subpopulation With PD-L1-Positive Tumor Status

    Overall survival (OS) defined as the time from randomization to the date of death from any cause in the subpopulation with PD-L1-positive tumor status.

    Measured: From randomization and up to study final analysis data cut off on 28 September 2022.

  7. Mean Scores for Function (Role/Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30

    Mean score in function (role, physical) and global health status(GHS)/ health-related quality of life (HRQoL) by cycle and between treatment arms as assessed by the functional and HRQoL scales of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core30(QLQ C30). The score range for each scale and single-item measure is 0 to 100, where higher scores indicate a higher response level (i.e., better functioning, better QoL, worse symptoms).

    Measured: From randomization and up to study final analysis data cut off on 28 September 2022.

  8. Mean Change From Baseline Scores for Function (Role, Physical) and GHS/HRQoL by Cycle and Between Treatment Arms as Assessed by the EORTC QLQ-C30

    Mean change from baseline score in function (role, physical) and global health status(GHS)/ health-related quality of life (HRQoL) by cycle and between treatment arms as assessed by the functional and HRQoL scales of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core30(QLQ C30).

    Measured: From randomization and up to study final analysis data cut off on 28 September 2022.

  9. Percentage of Participants With at Least One Adverse Events (AEs)

    Percentage of participants with at least one adverse event.

    Measured: From randomization and up to study final analysis data cut off on 28 September 2022.

  10. Minimum Observed Serum Atezolizumab Concentration (Cmin)

    Minimum observed serum atezolizumab concentration.

    Measured: Pre-dose on Day 1 of Cycles 2, 3, 4, 6, 8, 12, and 16 (cycle length = 28 days from Cycles 1 to 5, and 21 days from Cycles 6 to 16)

  11. Maximum Observed Serum Atezolizumab Concentration (Cmax)

    Maximum observed atezolizumab concentration (Cmax).

    Measured: Day 1 of Cycle 1 post dose (cycle length = 28 days)

  12. Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab

    Percentage of participants with anti-drug antibodies (ADAs) to atezolizumab.

    Measured: Baseline up to approximately 20 months

Timeline

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

  1. First posted23 Jun 2017
  2. Study start24 Jul 2017
  3. Primary completion3 Apr 2020
  4. Study completion28 Sep 2022

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
333 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03197935
Sponsor's protocol ID
WO39392
Other IDs
2016-004734-22, 2016
Acronym
IMpassion031
Status last verified
Oct 2023
First submitted
21 Jun 2017
Last updated
26 Oct 2023
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Mittendorf EA, Assaf ZJ, Harbeck N, Zhang H, Saji S, Jung KH, Hegg R, Koehler A, Sohn J, Iwata H, Telli ML, Ferrario C, Punie K, Qamra A, Dieterich M, Xu Y, Liste-Hermoso M, Shearer-Kang E, Molinero L, Chui SY, Barrios CH. Peri-operative atezolizumab in early-stage triple-negative breast cancer: final results and ctDNA analyses from the randomized phase 3 IMpassion031 trial. Nat Med. 2025 Jul;31(7):2397-2404. doi: 10.1038/s41591-025-03725-4. Epub 2025 Jun 4.

    PubMed 40467898

  • Mittendorf EA, Zhang H, Barrios CH, Saji S, Jung KH, Hegg R, Koehler A, Sohn J, Iwata H, Telli ML, Ferrario C, Punie K, Penault-Llorca F, Patel S, Duc AN, Liste-Hermoso M, Maiya V, Molinero L, Chui SY, Harbeck N. Neoadjuvant atezolizumab in combination with sequential nab-paclitaxel and anthracycline-based chemotherapy versus placebo and chemotherapy in patients with early-stage triple-negative breast cancer (IMpassion031): a randomised, double-blind, phase 3 trial. Lancet. 2020 Oct 10;396(10257):1090-1100. doi: 10.1016/S0140-6736(20)31953-X. Epub 2020 Sep 20.

    PubMed 32966830

  • Perez-Garcia J, Soberino J, Racca F, Gion M, Stradella A, Cortes J. Atezolizumab in the treatment of metastatic triple-negative breast cancer. Expert Opin Biol Ther. 2020 Sep;20(9):981-989. doi: 10.1080/14712598.2020.1769063. Epub 2020 May 25.

    PubMed 32450725

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody, Nab-paclitaxel and Doxorubicin in people with Triple-negative Breast Cancer, run by Hoffmann-La Roche at 68 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 12 inclusion and 30 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 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in Germany, United States, Japan, Brazil, Belgium 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. Some participants in this study may receive a placebo. 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 2 Jun 2021). 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?

Number of Participants With Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System in ITT Population (time frame: After neoadjuvant study treatment and surgery, up to primary analysis data cut off on 03 ApriI 2020). 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 NCT03197935, which also lists 3 linked publications.

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 Oct 2023.

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