A Study of the Safety, Efficacy, and Pharmacokinetics of Tiragolumab in Combination With Atezolizumab and Chemotherapy in Participants With Triple-Negative Breast Cancer
NCT ID: NCT04584112
Last Updated: 2023-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
83 participants
INTERVENTIONAL
2020-09-28
2023-03-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A: Tiragolumab and Atezolizumab + Nab-paclitaxel
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.
Tiragolumab
Tiragolumab 840 milligrams (mg) administered by intravenous (IV) infusion on Day 1 of every 28-day cycle.
Atezolizumab
Atezolizumab 1680 mg administered by IV infusion on Day 1 of every 28-day cycle.
Nab-paclitaxel
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.
Cohort B: Tiragolumab and Atezolizumab + Nab-pac-carbo-AC
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.
Tiragolumab
Tiragolumab 420 mg administered by IV infusion Q2W.
Atezolizumab
Atezolizumab 840 mg administered by IV infusion Q2W.
Nab-paclitaxel
Nab-paclitaxel 125 mg/m\^2 administered by IV infusion QW.
Carboplatin
Carboplatin (area under the concentration-time curve \[AUC\]: 5 milligrams per milliliter per minute \[mg/mL/min\]) administered by IV infusion Q3W.
Doxorubicin
Doxorubicin 60 mg/m\^2 Q2W administered by IV infusion.
Cyclophosphamide
Cyclophosphamide 600 mg/m\^2 Q2W administered by IV infusion.
Granulocyte colony-stimulating factor (G-CSF)
G-CSF support for four doses.
Granulocyte-macrophage colony-stimulating factor (GM-CSF)
GM-CSF support for four doses.
Cohort B: Tiragolumab and Atezolizumab + Nab-pac-AC
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.
Tiragolumab
Tiragolumab 420 mg administered by IV infusion Q2W.
Atezolizumab
Atezolizumab 840 mg administered by IV infusion Q2W.
Nab-paclitaxel
Nab-paclitaxel 125 mg/m\^2 administered by IV infusion QW.
Doxorubicin
Doxorubicin 60 mg/m\^2 Q2W administered by IV infusion.
Cyclophosphamide
Cyclophosphamide 600 mg/m\^2 Q2W administered by IV infusion.
Granulocyte colony-stimulating factor (G-CSF)
G-CSF support for four doses.
Granulocyte-macrophage colony-stimulating factor (GM-CSF)
GM-CSF support for four doses.
Interventions
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Tiragolumab
Tiragolumab 840 milligrams (mg) administered by intravenous (IV) infusion on Day 1 of every 28-day cycle.
Atezolizumab
Atezolizumab 1680 mg administered by IV infusion on Day 1 of every 28-day cycle.
Nab-paclitaxel
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.
Tiragolumab
Tiragolumab 420 mg administered by IV infusion Q2W.
Atezolizumab
Atezolizumab 840 mg administered by IV infusion Q2W.
Nab-paclitaxel
Nab-paclitaxel 125 mg/m\^2 administered by IV infusion QW.
Carboplatin
Carboplatin (area under the concentration-time curve \[AUC\]: 5 milligrams per milliliter per minute \[mg/mL/min\]) administered by IV infusion Q3W.
Doxorubicin
Doxorubicin 60 mg/m\^2 Q2W administered by IV infusion.
Cyclophosphamide
Cyclophosphamide 600 mg/m\^2 Q2W administered by IV infusion.
Granulocyte colony-stimulating factor (G-CSF)
G-CSF support for four doses.
Granulocyte-macrophage colony-stimulating factor (GM-CSF)
GM-CSF support for four doses.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
São Paulo, São Paulo, Brazil
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
Essen, , Germany
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
Heidelberg, , Germany
Arkhangelsk Regional Clinical Oncology Dispensary
Arkhangelsk, Arhangelsk, Russia
SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"
Moskva, Moscow Oblast, Russia
Blokhin Cancer Research Center; Combined Treatment
Moskva, Moscow Oblast, Russia
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
Santiago de Compostela, LA Coruña, Spain
Hospital Universitario Virgen Macarena; Servicio de Oncologia
Seville, , Spain
Hospital Clínico Universitario de Valencia; Servicio de Oncología
Valencia, , Spain
China Medical University Hospital; Surgery
Taichung, , Taiwan
National Taiwan Uni Hospital; General Surgery
Taipei, , Taiwan
Countries
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Other Identifiers
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2020-000531-47
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CO42177
Identifier Type: -
Identifier Source: org_study_id
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