Evidence map›Paper›PMID 41297162›Full record

Trial reportESMO open2025

Safety and efficacy of tiragolumab, atezolizumab and chemotherapy for early-stage or PD-L1-positive advanced triple-negative breast cancer: a phase Ib study.

S Kuemmel, K H Jung, L Andrade, D Assad-Suzuki, L de la Cruz Merino, R Freitas-Junior, R Hegg, C-S Huang, H Martin, A Schneeweiss and 8 more

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in ESMO open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04584112 (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), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04584112 phase1completednot on this map

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

TypeinterventionalSponsorHoffmann-La RocheRan2020 to 2023Enrolled83ConditionsTriple-Negative Breast CancerArmsTiragolumab, Atezolizumab, Nab-paclitaxel, Carboplatin, Doxorubicin
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

S KuemmelBreast Unit, Kliniken Essen-Mitte, Essen, Germany; Charité - Universitätsmedizin Berlin, Department of Gynecology with Breast Center, Berlin, Germany. Electronic address: s.kuemmel@kem-med.com.
K H JungDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
L AndradeInstituto D'Or de Pesquisa e Ensino, Salvador, Brazil.
D Assad-SuzukiCentro de Oncologia - Hospital Sírio-Libanês, Brasília, Brazil.
L de la Cruz MerinoInstitute of Biomedicine of Seville, CSIC, Clinical Oncology Department, Virgen Macarena University Hospital and Department of Medicine, University of Seville, Seville, Spain.
R Freitas-JuniorFederal University of Goiás, Goiânia, Brazil.
R HeggHospital Pérola Byington, São Paulo, Brazil.
C-S HuangNational Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.
H MartinMedical Oncology Department, Fiona Stanley Hospital, Murdoch, Australia; School of Medicine, University of Western Australia, Perth, Australia.
A SchneeweissDivision of Gynecologic Oncology, National Center for Tumor Diseases, Heidelberg University Hospital and German Cancer Research Center, Heidelberg, Germany.
M DieterichProduct Development Oncology, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
A Nguyen DucData & Statistical Science Oncology, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Y FengProduct Development Safety, Genentech, South San Francisco, USA.
R MengClinical Science, Genentech, South San Francisco, USA.
A SwatProduct Development Oncology, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
A SeillerClinical Science PD Oncology, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
B BermejoMedical Oncology Department, Clinic University Hospital, Valencia, Spain; Biomedical Research Institute, INCLIVA, Valencia, Spain; Department of Medicine, Valencia University, Valencia, Spain.
E P HamiltonMedical Oncology, Sarah Cannon Research Institute, Nashville, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundImmune checkpoint inhibitors have transformed the management of triple-negative breast cancer (TNBC) but outcomes could be improved further. We explored combining the T-cell immunoreceptor with immunoglobulin and ITIM domains (TIGIT) inhibitor tiragolumab with atezolizumab-containing regimens for patients with early-stage or advanced TNBC. PATIENTS AND

methodsThis multinational open-label phase Ib study included two cohorts. In cohort A [programmed death-ligand 1 (PD-L1)-positive advanced TNBC], patients received first-line tiragolumab with atezolizumab and nab-paclitaxel. The primary endpoint was confirmed objective response rate. In cohort B (early-stage TNBC, irrespective of PD-L1 status), patients were randomised to receive tiragolumab, atezolizumab and sequential taxane- and anthracycline-based neoadjuvant therapy with (arm A) or without (arm B) carboplatin. The primary objective was to evaluate safety in arm A versus arm B.

resultsBetween September 2020 and October 2021, 83 patients were enrolled from 24 sites in eight countries. In cohort A (n = 41), the confirmed objective response rate was 54% [95% confidence interval (CI) 37% to 69%], median duration of response in 22 responding patients was 7.2 months (95% CI 4.9-13.1 months), median progression-free survival was 6.5 months (95% CI 5.4-9.0 months) and median overall survival was 24.6 months (95% CI 14.7 months-not estimable). Five patients (12%) discontinued tiragolumab for adverse events. In cohort B (n = 42), carboplatin was associated with more haematological effects but no increase in pathologic complete response rate [arm A: 46% (95% CI 24% to 68%); arm B: 55% (95% CI 32% to 77%)]. Adverse events led to treatment discontinuation in 23% and 20% of patients in arms A and B, respectively.

conclusionsThe activity of tiragolumab-containing regimens appeared similar to that of atezolizumab plus chemotherapy in randomised phase III trials in early-stage and advanced TNBC. The safety profile of all three regimens was consistent with previous experience of similar regimens in other tumour types and with symptoms of the underlying disease. CLINICAL

trial registrationClinicalTrials.gov NCT04584112.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenTriple Negative Breast NeoplasmsAdultAgedFemaleHumansMiddle AgedNeoplasm StagingPaclitaxelAntibodies, Monoclonal, HumanizedatezolizumabB7-H1 AntigenCD274 protein, humanPaclitaxelTiragolumabdual blockadeimmune checkpointTIGITtriple-negative breast cancer

Identifiers

PMID41297162
PMCPMC12689193

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.