Health Condition 1: null- Locally advanced or Metastatic Triple Negative Breast Cancer Health Condition 2: C50- Malignant neoplasm of breast
Conditions
Interventions
Intervention1: Placebo: Placebo will consist of the vehicle without the antibody. Placebo will be supplied in a single-use, 20cc glass vials containing 20 mL of solution. Placebo will be given by IV i
Sponsors
F HoffmannLa Roche Ltd
Roche Products India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Signed Informed Consent Form 2. Women or men aged =18 years 3. Patients with locally advanced or metastatic, histologically documented TNBC by central testing (HER2, ER and PR expression), not amenable to surgical therapy. 4. Eligible for taxane monotherapy. 5. No prior chemotherapy or targeted systemic therapy (including endocrine therapy) for inoperable locally advanced or metastatic TNBC. 6. ECOG performance status of 0 or 1 7. Life expectancy =12 weeks 8. Measurable disease, as defined by RECIST v1.1. 9. Women of child bearing potential must agree to either use a contraceptive method with a failure rate of =1% per year or to remain abstinent during the treatment period and for at least 5 months after the last dose of atezolizumab/placebo, or for at least 6 months after the last dose of paclitaxel
Exclusion criteria
Exclusion criteria: 1. Spinal cord compression 2. Known CNS disease, except for treated asymptomatic CNS metastases. 3. Leptomeningeal disease 4. Uncontrolled pleural effusion, pericardial effusion, or ascites 5. Uncontrolled tumour-related pain 6. Pregnant or lactating women, or intending to become pregnant during the study. 7. Significant cardiovascular disease, such as New York Heart Association (NYHA) cardiac disease (Class II or greater), MI within 3 months prior to randomisation, unstable arrhythmias, or unstable angina. 8. Major surgical procedure within 4 weeks prior to randomisation or anticipation of the need for a major surgical procedure during the study other than for diagnosis. 9. History of autoimmune disease. 10. Prior allogeneic stem cell or solid organ transplantation 11. Positive test for HIV 12. Active hepatitis B or hepatitis C 13. Active tuberculosis 14. Poor peripheral venous access
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of atezolizumab plus paclitaxel compared with placebo plus paclitaxel as measured by progression-free survival (PFS)Timepoint: Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [ Time Frame: From Day 1 to disease progression (PD) or death from any cause, assessed up to end of study (up to approximately 45 months) ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Biomarker Objective- To assess the activity and safety of atezolizumab according to programmed death-ligand 1 (PD-L1) statusTimepoint: Relationship between PD-L1 by immunohistochemistry in recently obtained tumour tissues, and clinical outcomes;Exploratory Efficacy Objectives- To evaluate PROs of function & disease/treatment-related symptoms To evaluate PROs of Global Health Status/HRQoL scale To evaluate & compare between treatment arms patient’s health utility To evaluate the burden of treatment associated with the addition of atezolizumab to paclitaxel Timepoint: Mean changes from baseline score in patient function & disease/treatment-related symptoms as assessed by EORTC QLQ-C30 and QLQ-BR23. Mean and mean changes from baseline score in HRQoL as assessed by the EORTC QLQ-C30. Health utility scores of the EQ-5D-5L questionnaire. GP5 item ("I am bothered by side effects of treatment") from the physical wellbeing subscale of the FACT-G Quality of Life instrument. ;Exploratory Immunogenicity Objective- To evaluate potential effects of ATAsTimepoint: Relationship between ATA status and efficacy, safety, or pharmacokinetic endpoints;Immunogenicity Objective- To evaluate the immunogenicity of atezolizumabTimepoint: Incidence of anti-therapeutic antibodies (ATAs) during the study relative to the prevalence of ATAs at baseline. For patients who show evidence of immune-mediated toxicity, samples will be collected and tested for anti-nuclear antibody (ANA), anti-double-stranded DNA antibody, circulating anti-neutrophil cytoplasmic antibody, and perinuclear anti-neutrophil cytoplasmic antibody. ;Pharmacokinetic Objective- a) To characterize the PK of atezolizumab when administered concomitantly with paclitaxel b) To characterize the PK of paclitaxel when administered concomitantly with atezolizumab Timepoint: Cmin and Cmax of Atezolizumab [ Pre-dose (0 hours) on Day 1 of Cycles 1(only for Cmin), 2, 3, 4, 8, 12, 16, and at every 8 cycles thereafter | — |
Countries
Algeria, Argentina, Brazil, Canada, China, Croatia, Czech Republic, Egypt, France, Germany, Greece, India, Israel, Italy, Morocco, Romania, Russian Federation, Saudi Arabia, Slovakia, Turkey, United Kingdom, United States of America, Viet Nam
Contacts
Public ContactManjula Ujagiri
Roche Products (India) Pvt. Ltd.
Outcome results
None listed