The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of tiragolumab in combination with atezolizumab and chemotherapy in participants with metastatic and early triple-negative breast cancer (TNBC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
83
Tiragolumab 840 milligrams (mg) administered by intravenous (IV) infusion on Day 1 of every 28-day cycle.
Atezolizumab 1680 mg administered by IV infusion on Day 1 of every 28-day cycle.
Nab-paclitaxel 100 milligrams per square meter (mg/m\^2) administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
Percentage of Participants With Adverse Events (Cohort B)
Time frame: Up to approximately 21 months
Confirmed Objective Response Rate ORR (Cohort A)
Time frame: Up to approximately 21 months
Percentage of Participants With Adverse Events (Cohort A)
Time frame: Up to approximately 21 months
Progression-free Survival (Cohort A)
Time frame: Up to approximately 21 months
Duration of Response (Cohort A)
Time frame: Up to approximately 21 months
Overall Survival (Cohort A)
Time frame: Up to approximately 21 months
Serum Concentrations of Tiragolumab
TD visit: treatment discontinuation visit
Time frame: Cohort A: Day 1 of Cycles (cycle=28 days) 1, 2, 3, 4, 8, 12, and 16 and at TD visit from start of treatment up to approximately 17 months; Cohort B: Day 1 of Cycles (cycle=28 days) 1-5 and at TD visit from start of treatment up to approximately 5 months
Serum Concentrations of Atezolizumab
Time frame: Cohort A: Day 1 of Cycles (cycle=28 days) 1, 2, 3, 4, 8, 12, and 16 and at TD visit from start of treatment up to approximately 17 months; Cohort B: Day 1 of Cycles (cycle=28 days) 1-5 and at TD visit from start of treatment up to approximately 5 months
Plasma Concentrations of Nab-paclitaxel (Cohort B)
Time frame: Cohort B: Day 1 of Cycles (cycle=28 days) 1-5 and at TD visit from start of treatment up to approximately 5 months
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Tiragolumab 420 mg administered by IV infusion Q2W.
Atezolizumab 840 mg administered by IV infusion Q2W.
Nab-paclitaxel 125 mg/m\^2 administered by IV infusion QW.
Carboplatin (area under the concentration-time curve \[AUC\]: 5 milligrams per milliliter per minute \[mg/mL/min\]) administered by IV infusion Q3W.
Doxorubicin 60 mg/m\^2 Q2W administered by IV infusion.
Cyclophosphamide 600 mg/m\^2 Q2W administered by IV infusion.
G-CSF support for four doses.
GM-CSF support for four doses.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Univ of Chicago
Chicago, Illinois, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Magee-Woman's Hospital
Pittsburgh, Pennsylvania, United States
Tennessee Onc., PLLC - SCRI
Nashville, Tennessee, United States
Mater Hospital; Cancer Services
South Brisbane, Queensland, Australia
Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit
Bull Creek, Western Australia, Australia
Hospital Sao Rafael - HSR
Salvador, Estado de Bahia, Brazil
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
Goiânia, Goiás, Brazil
Hospital Sírio-Libanês
São Paulo, São Paulo, Brazil
...and 14 more locations
Plasma Concentrations of Carboplatin (Cohort B)
Time frame: Cohort B: Day 1 of Cycles (cycle=28 days) 1-5 and at TD visit from start of treatment up to approximately 5 months
Plasma Concentrations of Doxorubicin (Cohort B)
Time frame: Cohort B: Day 1 of Cycles (cycle=28 days) 1-5 and at TD visit from start of treatment up to approximately 5 months
Plasma Concentrations of Cyclophosphamide (Cohort B)
Time frame: Cohort B: Day 1 of Cycles (cycle=28 days) 1-5 and at TD visit from start of treatment up to approximately 5 months
Percentage of Participants With Anti-drug Antibodies (ADAs) to Tiragolumab
Time frame: Cohort A: Day 1 of Cycles (cycle=28 days) 1, 2, 3, 4, 8, 12, and 16 and at TD visit from start of treatment up to approximately 17 months; Cohort B: Day 1 of Cycles (cycle=28 days) 1-5 and at TD visit from start of treatment up to approximately 5 months
Percentage of Participants With ADAs to Atezolizumab
Time frame: Cohort A: Day 1 of Cycles (cycle=28 days) 1, 2, 3, 4, 8, 12, and 16 and at TD visit from start of treatment up to approximately 17 months; Cohort B: Day 1 of Cycles (cycle=28 days) 1-5 and at TD visit from start of treatment up to approximately 5 months