Comparing 8 approaches for breast cancer

Exclusion

• −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 or any component of the atezolizumab formulation.
• −Myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
• −Positive test for HIV (participants with a history of/or symptoms of HIV are eligible only if serological tests are negative).
• −Participants with hepatitis B virus (HBV) are excluded if one of the following conditions is met:
• −Positive hepatitis B surface antigen (HBsAg) test at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →; or
• −Negative or positive hepatitis B surface antibody (HBsAb) test at screening accompanied by a positive total hepatitis B core antibody (HBcAb) test followed by a positive (per local laboratory definition) HBV DNA test.
• −Positive hepatitis C virus (HCV) antibody test followed by a positive HCV RNA test at screening.
• −Any prior treatment with monoclonal antibodies targeting the Programmed Death 1/Ligand (PD-1/PD-L1) axis, including antibody-drug conjugates and other experimental agents.
• −Treatment with any approved or investigational agent or participation in another clinical trialInterventional studyA study where participants are given something to see what happens.Read more → with therapeutic intent within 14 days or five half-lives of the drug, whichever is longer, prior to enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →. Participants receiving gonadotropin releasing hormone (GnRH) analogues may continue to receive treatment while participating in CAPTIV-8.
• −Active autoimmune disease at any point within the last 2 years prior to enrollment including but not limited to:
• −Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid-replacement hormone may be eligible for this study.
• −Participants with controlled Type I diabetes mellitus on a stable dose of insulin regimen are eligible for this study.
• −Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., participants with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:
• −Rash must cover less than 10% (ten percent) of body surface area (BSA).
• −Disease is well controlled at baselineBaselineYour starting measurements, taken before treatment begins.Read more → and only requiring low potency topical steroids.
• −Active tuberculosis.
• −Severe infections within 2 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
• −Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 3 months, unstable arrhythmias, or unstable angina.
• −Major surgical procedure within 21 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study.
• −Prior allogeneic stem cell or solid organ transplant.
• −Treatment with systemic immunostimulatory agents (including but not limited to interferons, interleukin-2 (IL-2)) within 6 weeks or five half-lives of the drug, whichever is shorter, prior to Cycle 1, Day 1.
• −Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumour necrosis factor \[anti-TNF\] agents) within 2 weeks prior to Cycle 1, Day 1, or anticipated requirement for systemic immunosuppressive medications during the trial.
• −Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab.
• −Participants who are otherwise felt by the treating clinician to be unfit to proceed with this protocolProtocolThe detailed plan a study must follow.Read more →.
• −Pregnancy or breastfeeding.
• −No acute exacerbations of underlying condition within the last 12 months requiring treatment with either psoralen plus ultraviolet radiation (PUVA), methotrexate, retinoids, biologic agents, oral calcineurin inhibitors or high potency or oral steroids.
• −History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.