Triple-Negative Breast Cancer (TNBC) MedDRA version: 20.0 Level: PT Classification code 10075566 Term: Triple negative breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female >= 18 years of age - Histologically confirmed TNBC that is either locally recurrent, inoperable and cannot be treated with curative intent or is metastatic - Prior treatment with an anthracycline and taxane - Documented disease progression occurring within 12 months (= 12 weeks - Adequate haematologic and end-organ function, Negative human immunodeficiency virus (HIV) test at screening - Negative hepatitis B surface antigen (HBsAg) test at screening - Negative total hepatitis B core antibody (HBcAb) test at screening, or positive HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening - Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening - The HCV RNA test will be performed only for patients who have a positive HCV antibody test - Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range 58
Exclusion criteria
Exclusion criteria: - Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for > 2 weeks prior to randomisation - Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases - Symptomatic or rapid visceral progression - History of leptomeningeal disease - Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures - Uncontrolled tumour-related pain - Uncontrolled or symptomatic hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy - Malignancies other than TNBC within 5 years prior to randomisation, with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%) and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, non melanoma skin carcinoma, localised prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer) - Significant cardiovascular disease - Presence of an abnormal ECG that is clinically significant in the investigator’s opinion - Severe infection requiring oral or IV antibiotics within 4 weeks prior to randomisation, including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia - Current treatment with anti-viral therapy for HBV - Major surgical procedure within 4 weeks prior to randomisation or anticipation of the need for a major surgical procedure during the course of the study other than for diagnosis - Treatment with investigational therapy within 28 days prior to randomisation - Pregnant or lactating, or intending to become pregnant during or within 5 months after the last dose of study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the efficacy of atezolizumab plus chemotherapy compared to placebo plus chemotherapy based on overall survival;Secondary Objective: • To evaluate the efficacy of atezolizumab plus chemotherapy compared to placebo plus chemotherapy based on survival rate, progression free survival, objective response rate, duration of objective response, clinical benefit rate • To evaluate patient-reported outcomes (PROs) of global health status (GHS)/health-related quality of life (HRQoL) associated with atezolizumab plus chemotherapy compared with chemotherapy alone, as measured by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) • To evaluate the safety of atezolizumab plus chemotherapy compared with placebo plus chemotherapy • To characterize the pharmacokinetics (PK) of atezolizumab when administered with carboplatin/gemcitabine or with capecitabine in patients with breast cancer • To evaluate the immunogenicity of atezolizumab • To assess the efficacy and safety of atezolizumab plus chemotherapy according to programmed death-ligand 1 (PD-L1) status;Primary end point(s): 1. Overall survival;Timepoint(s) of evaluation of this end point: 1. Up to 35 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. 12-month survival rate 2. 18-month survival rate 3. Progression-free survival 4. Objective response rate 5. Duration of objective response 6. Clinical benefit rate 7. Time to deterioration (TTD) of GHS/HRQoL 8. Incidence, nature and severity of adverse events (AEs), with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0) 9. Change from baseline in targeted vital signs and physical findings 10. Change from baseline in targeted clinical laboratory test results 11. Maximum and minimum observed serum concentration (Cmax and Cmin) of atezolizumab 12. Incidence of anti-drug antibodies (ADAs) during the study relative to the prevalence of ADAs at baseline. 13. Relationship between PD-L1 protein expression by immunohistochemistry (Ventana® SP142 assay) in screening tumour tissue and clinical outcomes ;Timepoint(s) of evaluation of this end point: 1. Month 12 2. Month 18 3-13. Up to 41 months | — |
Countries
Algeria, Bosnia and Herzegovina, Brazil, Cuba, Egypt, Finland, France, Germany, Hong Kong, Hungary, Italy, Kazakhstan, Korea, Republic of, Mexico, Morocco, Panama, Poland, Portugal, Russian Federation, Serbia, Singapore, South Africa, Spain, Turkey, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche Ltd
Outcome results
None listed