A Study of the Safety, Efficacy, and Pharmacokinetics of Tiragolumab in Combination With Atezolizumab and Chemotherapy in Participants With Triple-Negative Breast Cancer
A Phase Ib, Open-Label, Multicohort Study of the Safety, Efficacy, and Pharmacokinetics of Tiragolumab in Combination With Atezolizumab and Chemotherapy in Patients With Triple-Negative Breast Cancer
2 other identifiers
interventional
83
8 countries
24
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2020
Typical duration for phase_1
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 28, 2020
CompletedFirst Submitted
Initial submission to the registry
October 5, 2020
CompletedFirst Posted
Study publicly available on registry
October 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 8, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 8, 2023
CompletedMarch 15, 2023
March 1, 2023
2.4 years
October 5, 2020
March 13, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Adverse Events (Cohort B)
Up to approximately 21 months
Confirmed Objective Response Rate ORR (Cohort A)
Up to approximately 21 months
Secondary Outcomes (12)
Percentage of Participants With Adverse Events (Cohort A)
Up to approximately 21 months
Progression-free Survival (Cohort A)
Up to approximately 21 months
Duration of Response (Cohort A)
Up to approximately 21 months
Overall Survival (Cohort A)
Up to approximately 21 months
Serum Concentrations of Tiragolumab
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
- +7 more secondary outcomes
Study Arms (3)
Cohort A: Tiragolumab and Atezolizumab + Nab-paclitaxel
EXPERIMENTALParticipants 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.
Cohort B: Tiragolumab and Atezolizumab + Nab-pac-carbo-AC
EXPERIMENTALParticipants 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.
Cohort B: Tiragolumab and Atezolizumab + Nab-pac-AC
EXPERIMENTALParticipantswith 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify 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 qualify 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300, United States
Univ of Chicago
Chicago, Illinois, 60637, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Magee-Woman's Hospital
Pittsburgh, Pennsylvania, 15213, United States
Tennessee Onc., PLLC - SCRI
Nashville, Tennessee, 37203, United States
Mater Hospital; Cancer Services
South Brisbane, Queensland, 4101, Australia
Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit
Bull Creek, Western Australia, 6149, Australia
Hospital Sao Rafael - HSR
Salvador, Estado de Bahia, 41253-190, Brazil
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
Goiânia, Goiás, 74605-070, Brazil
Hospital Sírio-Libanês
São Paulo, São Paulo, 01308-050, Brazil
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
São Paulo, São Paulo, 01317-001, Brazil
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
Essen, 45136, Germany
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
Heidelberg, 69120, Germany
Arkhangelsk Regional Clinical Oncology Dispensary
Arkhangelsk, Arhangelsk, 163045, Russia
SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"
Moskva, Moscow Oblast, 111123, Russia
Blokhin Cancer Research Center; Combined Treatment
Moskva, Moscow Oblast, 115478, Russia
Severance Hospital, Yonsei University Health System
Seoul, 003-722, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
Santiago de Compostela, LA Coruña, 15706, Spain
Hospital Universitario Virgen Macarena; Servicio de Oncologia
Seville, 41009, Spain
Hospital Clínico Universitario de Valencia; Servicio de Oncología
Valencia, 46010, Spain
China Medical University Hospital; Surgery
Taichung, 404, Taiwan
National Taiwan Uni Hospital; General Surgery
Taipei, 100, Taiwan
Related Publications (1)
Kuemmel S, Jung KH, Andrade L, Assad-Suzuki D, de la Cruz Merino L, Freitas-Junior R, Hegg R, Huang CS, Martin H, Schneeweiss A, Dieterich M, Nguyen Duc A, Feng Y, Meng R, Swat A, Seiller A, Bermejo B, Hamilton EP. Safety and efficacy of tiragolumab, atezolizumab and chemotherapy for early-stage or PD-L1-positive advanced triple-negative breast cancer: a phase Ib study. ESMO Open. 2025 Dec;10(12):105869. doi: 10.1016/j.esmoop.2025.105869. Epub 2025 Nov 25.
PMID: 41297162DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trial
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2020
First Posted
October 12, 2020
Study Start
September 28, 2020
Primary Completion
March 8, 2023
Study Completion
March 8, 2023
Last Updated
March 15, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).