Breast Cancer Clinical Trial

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

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 nab-pac-AC in participants eligible for surgery with initial clinically assessed triple-negative breast cancer (TNBC).

View Eligibility Criteria

Eligibility Criteria

Inclusion criteria:

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
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:

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
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

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

333

Study ID:

NCT03197935

Recruitment Status:

Completed

Sponsor:

Hoffmann-La Roche

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There are 69 Locations for this study

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Stanford University Medical Center
Palo Alto California, 94304, United States
Norwalk Hospital
Norwalk Connecticut, 06856, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Carrollton Georgia, 30117, United States
Mercy Medical Center
Baltimore Maryland, 21202, United States
HCA Midwest Division
Kansas City Missouri, 64132, United States
The Valley Hospital; Valley Medical Group
Paramus New Jersey, 07652, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Tennessee Oncology - Chattanooga; Tennessee Oncology - East Third Street
Chattanooga Tennessee, 37404, United States
Tennessee Oncology
Nashville Tennessee, 37203, United States
Vanderbilt Breast Center at One Hundred Oaks
Nashville Tennessee, 37204, United States
The Center for Cancer and Blood Disorders - Fort Worth
Fort Worth Texas, 76104, United States
Cancer Care Northwest
Spokane Washington, 99204, United States
Monash Medical Centre
Clayton Victoria, 3168, Australia
Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit
Bull Creek Western Australia, 6149, Australia
Cliniques Universitaires St-Luc
Bruxelles , 1200, Belgium
UZ Leuven Gasthuisberg
Leuven , 3000, Belgium
Clinique Ste-Elisabeth
Namur , 5000, Belgium
Sint Augustinus Wilrijk
Wilrijk , 2610, Belgium
Santa Casa de Misericordia de Salvador
Salvador BA, 40050, Brazil
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
Goiania GO, 74605, Brazil
CETUS Hospital Dia Oncologia
Uberaba MG, 38082, Brazil
Iop Instituto de Oncologia Do Parana
Curitiba PR, 80530, Brazil
Clinicas Oncologicas Integradas - COI
Rio De Janeiro RJ, 22290, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre RS, 90610, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre RS, 91350, Brazil
Centro de Pesquisas Oncologicas - CEPON
Florianopolis SC, 88034, Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
Sao Paulo SP, 01317, Brazil
Jewish General Hospital
Montreal Quebec, H3T 1, Canada
Hopital Sacre-Coeur Research Centre
Montreal Quebec, H4J 1, Canada
Hopital du Saint Sacrement
Quebec City Quebec, G1S 4, Canada
Hochwaldkrankenhaus
Bad Nauheim , 61231, Germany
Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)
Berlin , 10367, Germany
Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters
Berlin , 13581, Germany
Onkologische Schwerpunktpraxis Bielefeld
Bielefeld , 33604, Germany
Luisenkrankenhaus GmbH & Co. KG., Brustzentrum
Düsseldorf , 40235, Germany
Evangelische Kliniken Gelsenkirchen GmbH; Brustzentrum
Gelsenkirchen , 45879, Germany
Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
Hamburg , 20357, Germany
Diakovere Henriettenstift, Frauenklinik
Hannover , 30559, Germany
Dres. Andreas Köhler und Roswitha Fuchs
Langen , 63225, Germany
St. Elisabeth-Krankenhaus, Senologie/Brustzentrum
Leipzig , 04277, Germany
Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
München , 80336, Germany
Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe
Münster , 48149, Germany
Medizinisches Versorgungszentrum am Klinikum Oldenburg GmbH
Oldenburg , 26133, Germany
Irccs Ospedale San Raffaele
Milano Lombardia, 20132, Italy
Ospedale San Gerardo
Monza Lombardia, 20900, Italy
Azienda ULSS 8 Berica; Oncologia Medica - Ospedlae di Vicenza
Vicenza Veneto, 36100, Italy
Aichi Cancer Center Hospital
Aichi , 464-8, Japan
National Hospital Organization Shikoku Cancer Center
Ehime , 791-0, Japan
Fukushima Medical University Hospital
Fukushima , 960-1, Japan
Hiroshima City Hiroshima Citizens Hospital; Breast Surgery
Hiroshima , 730-8, Japan
Kanagawa Cancer Center
Kanagawa , 241-8, Japan
Tokai University Hospital
Kanagawa , 259-1, Japan
National Hospital Organization Osaka National Hospital; Breast Surgery
Osaka , 540-0, Japan
St. Luke's Internat. Hospital, Breast Surgical Oncology
Tokyo , 104-8, Japan
The Cancer Inst. Hosp. of JFCR; Breast Oncology Center
Tokyo , 135-8, Japan
National Cancer Center
Goyang-si , 10408, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr
Warszawa , 02-78, Poland
Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii; Oddz. Onkologii Klin. i Chemioterapii
Wrocław , 53-41, Poland
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid , 28041, Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla , 41013, Spain
VETERANS GENERAL HOSPITAL; Department of General Surgery
Taipei , 00112, Taiwan
Mackay Memorial Hospital; Dept of Surgery
Taipei , 104, Taiwan
Chang Gung Medical Foundation Linkou Branch
Taoyuan City , 333, Taiwan
Leicester Royal Infirmary
Leicester , LE1 5, United Kingdom
Barts & London School of Med; Medical Oncology
London , EC1A , United Kingdom
Freeman Hospital
Newcastle upon Tyne , NE7 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

333

Study ID:

NCT03197935

Recruitment Status:

Completed

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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