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
A Study of the Safety, Efficacy, and Pharmacokinetics of Tiragolumab in Combination With Atezolizumab and Chemotherapy in Participants With Triple-Negative Breast Cancer
Saves the questions and what to expect into your notes, next to the visit they belong to.
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
