A Study of the Safety, Efficacy, and Pharmacokinetics of Tiragolumab in Combination With Atezolizumab and Chemotherapy in Participants With Triple-Negative Breast Cancer
Status and phase
Completed
Phase 1
Conditions
Triple-Negative Breast Cancer
Treatments
Drug: Nab-paclitaxel
Drug: Granulocyte-macrophage colony-stimulating factor (GM-CSF)
Drug: Granulocyte colony-stimulating factor (G-CSF)
Drug: Atezolizumab
Drug: Tiragolumab
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Carboplatin
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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).
Enrollment
83 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
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
Exclusion Criteria
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
83 participants in 3 patient groups
Cohort A: Tiragolumab and Atezolizumab + Nab-paclitaxel
Experimental group
Description:
Participants with first-line metastatic TNBC will receive tiragolumab and atezolizumab on Day 1 of every 28-day cycle plus nab-paclitaxel on Days 1, 8, and 15 of every 28-day cycle.
Treatment:
Drug: Tiragolumab
Drug: Atezolizumab
Drug: Nab-paclitaxel
Drug: Atezolizumab
Drug: Tiragolumab
Drug: Nab-paclitaxel
Cohort B: Tiragolumab and Atezolizumab + Nab-pac-carbo-AC
Experimental group
Description:
Participants with early TNBC in the neoadjuvant setting, who are eligible for surgery, will receive tiragolumab and atezolizumab every 2 weeks (Q2W) in combination with nab-paclitaxel weekly (QW) and carboplatin every 3 weeks (Q3W) for four cycles, followed by tiragolumab and atezolizumab in combination with doxorubicin and cyclophosphamide Q2W with granulocyte colony-stimulating factor (G-CSF; filgrastim or pegfilgrastim) or granulocyte-macrophage colony-stimulating factor (GM-CSF) support for four doses.
Treatment:
Drug: Tiragolumab
Drug: Atezolizumab
Drug: Granulocyte-macrophage colony-stimulating factor (GM-CSF)
Drug: Nab-paclitaxel
Drug: Carboplatin
Drug: Atezolizumab
Drug: Tiragolumab
Drug: Nab-paclitaxel
Drug: Granulocyte colony-stimulating factor (G-CSF)
Drug: Cyclophosphamide
Drug: Doxorubicin
Cohort B: Tiragolumab and Atezolizumab + Nab-pac-AC
Experimental group
Description:
Participantswith early TNBC in the neoadjuvant setting, who are eligible for surgery, will receive tiragolumab and atezolizumab Q2W in combination with nab-paclitaxel QW for 12 weeks, followed by tiragolumab and atezolizumab in combination with doxorubicin and cyclophosphamide Q2W with G-CSF (filgrastim or pegfilgrastim) or GM-CSF support for four doses.
Treatment:
Drug: Tiragolumab
Drug: Atezolizumab
Drug: Granulocyte-macrophage colony-stimulating factor (GM-CSF)
Drug: Nab-paclitaxel
Drug: Atezolizumab
Drug: Tiragolumab
Drug: Nab-paclitaxel
Drug: Granulocyte colony-stimulating factor (G-CSF)
Drug: Cyclophosphamide
Drug: Doxorubicin
Trial contacts and locations
24
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Data sourced from clinicaltrials.gov
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