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

Completed · Phase 3 · Has a placebo group

Conditions studied: Triple-negative Breast Cancer

In brief

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).

Key facts

Study ID

NCT03197935

Run by

Hoffmann-La Roche

People needed

333

Starts

2017-07-24

Expected to finish

2022-09-28

Last updated by the study team

2023-10-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Stanford University Medical Center — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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