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
NCT ID: NCT03197935
Last Updated: 2023-10-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
333 participants
INTERVENTIONAL
2017-07-24
2022-09-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Atezolizumab and Chemotherapy
Participants 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.
Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
Atezolizumab was administered as per schedule described in respective arm.
Nab-paclitaxel
Nab-paclitaxel was administered as per schedule described in the arms.
Doxorubicin
Doxorubicin was administered as per schedule described in the arms.
Cyclophosphamide
Cyclophosphamide was administered as per schedule described in the arms.
Filgrastim
Filgrastim was administered according to local prescribing information as determined by the Investigator for 4 doses after completion of initial 12 weeks.
Pegfilgrastim
Pegfilgrastim was administered according to local prescribing information as determined by the Investigator for 4 doses after completion of initial 12 weeks.
Placebo and Chemotherapy
Participants 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.
Placebo
Placebo matched to atezolizumab was administered as per schedule described in respective arm.
Nab-paclitaxel
Nab-paclitaxel was administered as per schedule described in the arms.
Doxorubicin
Doxorubicin was administered as per schedule described in the arms.
Cyclophosphamide
Cyclophosphamide was administered as per schedule described in the arms.
Filgrastim
Filgrastim was administered according to local prescribing information as determined by the Investigator for 4 doses after completion of initial 12 weeks.
Pegfilgrastim
Pegfilgrastim was administered according to local prescribing information as determined by the Investigator for 4 doses after completion of initial 12 weeks.
Interventions
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Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
Atezolizumab was administered as per schedule described in respective arm.
Placebo
Placebo matched to atezolizumab was administered as per schedule described in respective arm.
Nab-paclitaxel
Nab-paclitaxel was administered as per schedule described in the arms.
Doxorubicin
Doxorubicin was administered as per schedule described in the arms.
Cyclophosphamide
Cyclophosphamide was administered as per schedule described in the arms.
Filgrastim
Filgrastim was administered according to local prescribing information as determined by the Investigator for 4 doses after completion of initial 12 weeks.
Pegfilgrastim
Pegfilgrastim was administered according to local prescribing information as determined by the Investigator for 4 doses after completion of initial 12 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Stanford University Medical Center
Palo Alto, California, United States
Norwalk Hospital
Norwalk, Connecticut, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Carrollton, Georgia, United States
Mercy Medical Center
Baltimore, Maryland, United States
HCA Midwest Division
Kansas City, Missouri, United States
The Valley Hospital; Valley Medical Group
Paramus, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Tennessee Oncology - Chattanooga; Tennessee Oncology - East Third Street
Chattanooga, Tennessee, United States
Tennessee Oncology
Nashville, Tennessee, United States
Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee, United States
The Center for Cancer and Blood Disorders - Fort Worth
Fort Worth, Texas, United States
Cancer Care Northwest
Spokane, Washington, United States
Monash Medical Centre
Clayton, Victoria, Australia
Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit
Bull Creek, Western Australia, Australia
Cliniques Universitaires St-Luc
Brussels, , Belgium
UZ Leuven Gasthuisberg
Leuven, , Belgium
Clinique Ste-Elisabeth
Namur, , Belgium
Sint Augustinus Wilrijk
Wilrijk, , Belgium
Santa Casa de Misericordia de Salvador
Salvador, Estado de Bahia, Brazil
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
Goiânia, Goiás, Brazil
CETUS Hospital Dia Oncologia
Uberaba, Minas Gerais, Brazil
Iop Instituto de Oncologia Do Parana
Curitiba, Paraná, Brazil
Clinicas Oncologicas Integradas - COI
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
São Paulo, São Paulo, Brazil
Jewish General Hospital
Montreal, Quebec, Canada
Hopital Sacre-Coeur Research Centre
Montreal, Quebec, Canada
Hopital du Saint Sacrement
Québec, Quebec, Canada
Hochwaldkrankenhaus
Bad Nauheim, , Germany
Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)
Berlin, , Germany
Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters
Berlin, , Germany
Onkologische Schwerpunktpraxis Bielefeld
Bielefeld, , Germany
Luisenkrankenhaus GmbH & Co. KG., Brustzentrum
Düsseldorf, , Germany
Evangelische Kliniken Gelsenkirchen GmbH; Brustzentrum
Gelsenkirchen, , Germany
Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
Hamburg, , Germany
Diakovere Henriettenstift, Frauenklinik
Hanover, , Germany
Dres. Andreas Köhler und Roswitha Fuchs
Langen, , Germany
St. Elisabeth-Krankenhaus, Senologie/Brustzentrum
Leipzig, , Germany
Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
München, , Germany
Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe
Münster, , Germany
Medizinisches Versorgungszentrum am Klinikum Oldenburg GmbH
Oldenburg, , Germany
Irccs Ospedale San Raffaele
Milan, Lombardy, Italy
Ospedale San Gerardo
Monza, Lombardy, Italy
Azienda ULSS 8 Berica; Oncologia Medica - Ospedlae di Vicenza
Vicenza, Veneto, Italy
Aichi Cancer Center Hospital
Aichi, , Japan
National Hospital Organization Shikoku Cancer Center
Ehime, , Japan
Fukushima Medical University Hospital
Fukushima, , Japan
Hiroshima City Hiroshima Citizens Hospital; Breast Surgery
Hiroshima, , Japan
Kanagawa Cancer Center
Kanagawa, , Japan
Tokai University Hospital
Kanagawa, , Japan
National Hospital Organization Osaka National Hospital; Breast Surgery
Osaka, , Japan
St. Luke's Internat. Hospital, Breast Surgical Oncology
Tokyo, , Japan
The Cancer Inst. Hosp. of JFCR; Breast Oncology Center
Tokyo, , Japan
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr
Warsaw, , Poland
Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii; Oddz. Onkologii Klin. i Chemioterapii
Wroc?aw, , Poland
National Cancer Center
Goyang-si, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, , Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Seville, , Spain
VETERANS GENERAL HOSPITAL; Department of General Surgery
Taipei, , Taiwan
Mackay Memorial Hospital; Dept of Surgery
Taipei, , Taiwan
Chang Gung Medical Foundation Linkou Branch
Taoyuan, , Taiwan
Leicester Royal Infirmary
Leicester, , United Kingdom
Barts & London School of Med; Medical Oncology
London, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-004734-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
WO39392
Identifier Type: -
Identifier Source: org_study_id
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