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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000531-47 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: Tiragolumab and Atezolizumab + Nab-paclitaxel | Experimental | 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. |
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| Cohort B: Tiragolumab and Atezolizumab + Nab-pac-carbo-AC | Experimental | 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. |
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| Cohort B: Tiragolumab and Atezolizumab + Nab-pac-AC | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiragolumab | Drug | Tiragolumab 840 milligrams (mg) administered by intravenous (IV) infusion on Day 1 of every 28-day cycle. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (Cohort A) | Up to approximately 21 months | |
| Progression-free Survival (Cohort A) | Up to approximately 21 months | |
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Inclusion Criteria
Cohort A:
Cohort B:
Exclusion Criteria
Cohort A:
Cohort B:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-3300 | United States | ||
| Univ of Chicago |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41297162 | Derived | 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. |
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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).
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| Atezolizumab | Drug | Atezolizumab 1680 mg administered by IV infusion on Day 1 of every 28-day cycle. |
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| Nab-paclitaxel | Drug | 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. |
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| Tiragolumab | Drug | Tiragolumab 420 mg administered by IV infusion Q2W. |
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| Atezolizumab | Drug | Atezolizumab 840 mg administered by IV infusion Q2W. |
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| Nab-paclitaxel | Drug | Nab-paclitaxel 125 mg/m^2 administered by IV infusion QW. |
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| Carboplatin | Drug | Carboplatin (area under the concentration-time curve [AUC]: 5 milligrams per milliliter per minute [mg/mL/min]) administered by IV infusion Q3W. |
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| Doxorubicin | Drug | Doxorubicin 60 mg/m^2 Q2W administered by IV infusion. |
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| Cyclophosphamide | Drug | Cyclophosphamide 600 mg/m^2 Q2W administered by IV infusion. |
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| Granulocyte colony-stimulating factor (G-CSF) | Drug | G-CSF support for four doses. |
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| Granulocyte-macrophage colony-stimulating factor (GM-CSF) | Drug | GM-CSF support for four doses. |
|
| Duration of Response (Cohort A) |
| Up to approximately 21 months |
| Overall Survival (Cohort A) | Up to approximately 21 months |
| Serum Concentrations of Tiragolumab | TD visit: treatment discontinuation visit | 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 | 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) | 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 Carboplatin (Cohort B) | 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) | 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) | 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 | 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 | 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 |
| 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 |
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000730814 | Tiragolumab |
| C000594389 | atezolizumab |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| D016190 | Carboplatin |
| D004317 | Doxorubicin |
| C506643 | liposomal doxorubicin |
| D003520 | Cyclophosphamide |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D000069585 | Filgrastim |
| C455861 | pegfilgrastim |
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D056831 | Coordination Complexes |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D001685 | Biological Factors |
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