A Study of the Safety, Efficacy, and Pharmacokinetics of Tiragolumab in Combination With Atezolizumab and Chemotherapy in Participants With Triple-Negative Breast Cancer
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Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Cohort A:
Metastatic or locally advanced unresectable, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expression
Only patients with metastatic TNBC tumors that are centrally tested and found to be programmed death-ligand 1 (PD-L1) positive will be enrolled
No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC
Eastern Cooperative Oncology Group performance status of 0 or 1
Measurable disease, as assessed by the investigator according to RECIST v1.1
Adequate hematologic and end-organ function
Cohort B:
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Histologically documented TNBC (negative HER2, ER, and PR status)
Confirmed tumor 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
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
You may not be if
Cohort A:
Formalin-fixed, paraffin-embedded (FFPE) tumor tissue that is PD-L1 negative, as determined on the SP142 PD-L1 immunohistochemistry assay, with positivity defined as immune cells greater than or equal to (\>/=) 1%
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 initiation of study treatment
Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases
Leptomeningeal disease
Cohort B:
History of invasive breast cancer
Stage IV (metastatic) breast cancer
Prior systemic therapy for treatment and prevention of breast cancer
Previous therapy with anthracyclines, platinum, or taxanes for any malignancy
Synchronous, bilateral invasive breast cancer
Cardiopulmonary dysfunction
Clareo Health | A Study of the Safety, Efficacy, and Pharmacokinetics of Tiragolumab in Combination With Atezolizumab and Chemotherapy in Participants With Triple-Negative Breast Cancer
