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

Conditions: 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).


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