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Triple-Negative Breast CancerPhase 1NCT04584112

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 1 study testing Tiragolumab, Atezolizumab and Nab-paclitaxel in people with Triple-Negative Breast Cancer, run by Hoffmann-La Roche at 24 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Triple-Negative Breast Cancer
What is being tested?
Tiragolumab, Atezolizumab and Nab-paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
24 sitesin 8 countries
Study dates
28 Sep 2020to 8 Mar 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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:
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  • 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 locations and contacts

24 sites in 8 countries.

24 sites in 8 countries

United States5 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294-3300

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Univ of Chicago

    Chicago, Illinois, 60637

  • Tennessee Onc., PLLC - SCRI

    Nashville, Tennessee, 37203

  • Magee-Woman's Hospital

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

Brazil4 sites

  • Hospital Araujo Jorge; Departamento de Ginecologia E Mama

    Goiânia, Goiás, 74605-070

  • Hospital Sao Rafael - HSR

    Salvador, Estado de Bahia, 41253-190

  • Hospital Sírio-Libanês

    São Paulo, São Paulo, 01308-050

  • Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

    São Paulo, São Paulo, 01317-001

Other trials in Brazil

Russia3 sites

  • Arkhangelsk Regional Clinical Oncology Dispensary

    Arkhangelsk, Arhangelsk, 163045

  • SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"

    Moskva, Moscow Oblast, 111123

  • Blokhin Cancer Research Center; Combined Treatment

    Moskva, Moscow Oblast, 115478

Other trials in Russia

South Korea3 sites

  • Severance Hospital, Yonsei University Health System

    Seoul, 003-722

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

Spain3 sites

  • Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

    Santiago de Compostela, LA Coruña, 15706

  • Hospital Universitario Virgen Macarena; Servicio de Oncologia

    Seville, 41009

  • Hospital Clínico Universitario de Valencia; Servicio de Oncología

    Valencia, 46010

Other trials in Spain

Australia2 sites

  • Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit

    Bull Creek, Western Australia, 6149

  • Mater Hospital; Cancer Services

    South Brisbane, Queensland, 4101

Other trials in Australia

Germany2 sites

  • Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum

    Essen, 45136

  • Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg

    Heidelberg, 69120

Other trials in Germany

Taiwan2 sites

  • China Medical University Hospital; Surgery

    Taichung, 404

  • National Taiwan Uni Hospital; General Surgery

    Taipei, 100

Other trials in Taiwan

About this study

Official title: 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

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).

Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TiragolumabDrug

    Tiragolumab 840 milligrams (mg) administered by intravenous (IV) infusion on Day 1 of every 28-day cycle.

  • AtezolizumabDrug

    Also called Tecentriq

    Atezolizumab 1680 mg administered by IV infusion on Day 1 of every 28-day cycle.

  • Nab-paclitaxelDrug

    Also called Abraxane

    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.

  • TiragolumabDrug

    Tiragolumab 420 mg administered by IV infusion Q2W.

  • AtezolizumabDrug

    Also called Tecentriq

    Atezolizumab 840 mg administered by IV infusion Q2W.

  • Nab-paclitaxelDrug

    Also called Abraxane

    Nab-paclitaxel 125 mg/m^2 administered by IV infusion QW.

  • CarboplatinDrug

    Carboplatin (area under the concentration-time curve [AUC]: 5 milligrams per milliliter per minute [mg/mL/min]) administered by IV infusion Q3W.

  • DoxorubicinDrug

    Also called Lipodox, Doxil

    Doxorubicin 60 mg/m^2 Q2W administered by IV infusion.

  • CyclophosphamideDrug

    Cyclophosphamide 600 mg/m^2 Q2W administered by IV infusion.

  • Granulocyte colony-stimulating factor (G-CSF)Drug

    Also called filgrastim, pegfilgrastim

    G-CSF support for four doses.

  • Granulocyte-macrophage colony-stimulating factor (GM-CSF)Drug

    GM-CSF support for four doses.

Study groups in NCT04584112
Study groupRoleWhat they receive
Cohort A: Tiragolumab and Atezolizumab + Nab-paclitaxelExperimentalParticipants 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.
Receives: Drug: Tiragolumab; Drug: Atezolizumab; Drug: Nab-paclitaxel
Cohort B: Tiragolumab and Atezolizumab + Nab-pac-carbo-ACExperimentalParticipants 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.
Receives: Drug: Tiragolumab; Drug: Atezolizumab; Drug: Nab-paclitaxel; Drug: Carboplatin; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Granulocyte colony-stimulating factor (G-CSF); Drug: Granulocyte-macrophage colony-stimulating factor (GM-CSF)
Cohort B: Tiragolumab and Atezolizumab + Nab-pac-ACExperimentalParticipantswith 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.
Receives: Drug: Tiragolumab; Drug: Atezolizumab; Drug: Nab-paclitaxel; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Granulocyte colony-stimulating factor (G-CSF); Drug: Granulocyte-macrophage colony-stimulating factor (GM-CSF)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Adverse Events (Cohort B)

    Measured: Up to approximately 21 months

  2. Confirmed Objective Response Rate ORR (Cohort A)

    Measured: Up to approximately 21 months

Secondary outcomes (12)

  1. Percentage of Participants With Adverse Events (Cohort A)

    Measured: Up to approximately 21 months

  2. Progression-free Survival (Cohort A)

    Measured: Up to approximately 21 months

  3. Duration of Response (Cohort A)

    Measured: Up to approximately 21 months

  4. Overall Survival (Cohort A)

    Measured: Up to approximately 21 months

  5. Serum Concentrations of Tiragolumab

    TD visit: treatment discontinuation visit

    Measured: 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

  6. Serum Concentrations of Atezolizumab

    Measured: 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. Plasma Concentrations of Nab-paclitaxel (Cohort B)

    Measured: Cohort B: Day 1 of Cycles (cycle=28 days) 1-5 and at TD visit from start of treatment up to approximately 5 months

  8. Plasma Concentrations of Carboplatin (Cohort B)

    Measured: Cohort B: Day 1 of Cycles (cycle=28 days) 1-5 and at TD visit from start of treatment up to approximately 5 months

  9. Plasma Concentrations of Doxorubicin (Cohort B)

    Measured: Cohort B: Day 1 of Cycles (cycle=28 days) 1-5 and at TD visit from start of treatment up to approximately 5 months

  10. Plasma Concentrations of Cyclophosphamide (Cohort B)

    Measured: Cohort B: Day 1 of Cycles (cycle=28 days) 1-5 and at TD visit from start of treatment up to approximately 5 months

  11. Percentage of Participants With Anti-drug Antibodies (ADAs) to Tiragolumab

    Measured: 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

  12. Percentage of Participants With ADAs to Atezolizumab

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2020
  2. Study start28 Sep 2020
  3. Primary completion8 Mar 2023
  4. Study completion8 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04584112
Sponsor's protocol ID
CO42177
Other IDs
2020-000531-47
Status last verified
Mar 2023
First submitted
5 Oct 2020
Last updated
15 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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).

Publications

  • 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.

    PubMed 41297162

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tiragolumab, Atezolizumab and Nab-paclitaxel in people with Triple-Negative Breast Cancer, run by Hoffmann-La Roche at 24 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, Brazil, Russia, South Korea, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Adverse Events (Cohort B) (time frame: Up to approximately 21 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04584112, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.

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