Evidence map›Paper›PMID 38686016›Full record

ArticleTherapeutic advances in medical oncology2024

TROPION-Breast03: a randomized phase III global trial of datopotamab deruxtecan ± durvalumab in patients with triple-negative breast cancer and residual invasive disease at surgical resection after neoadjuvant therapy.

Aditya Bardia, Lajos Pusztai, Kathy Albain, Eva Maria Ciruelos, Seock-Ah Im, Dawn Hershman, Kevin Kalinsky, Claudine Isaacs, Delphine Loirat, Laura Testa and 8 more

Registry-linked trialAbstract read
In one paragraph

Article in Therapeutic advances in medical oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05629585 (A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan), which is not on this map. Cited by 40 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 3 pooled it
–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.

NCT05629585 phase3active not recruitingnot on this map

A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (DatoDXd) With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy (TROPION-Breast03)

TypeinterventionalSponsorAstraZenecaRan2022 to 2030Enrolled1,174ConditionsBreast CancerArmsDato-DXd, Durvalumab, Capecitabine, Pembrolizumab
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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  16. Advances in Immunotherapy for Breast Cancer.Oncology (Williston Park, N.Y.) · 2026
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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.

Aditya BardiaJonsson Comprehensive Cancer Center, University of California Los Angeles, Los Angeles, CA, USA.ORCID https://orcid.org/0000-0003-4885-1157
Lajos PusztaiYale University, New Haven, CT, USA.
Kathy AlbainLoyola University Chicago Stritch School of Medicine, Cardinal Bernardin Cancer Center, Maywood, IL, USA.
Eva Maria CiruelosHospital Universitario 12 de Octubre, Madrid, Spain and HM Hospitales, Madrid, Spain.
Seock-Ah ImSeoul National University College of Medicine, Cancer Research Institute, Seoul National University, Seoul, Republic of Korea.
Dawn HershmanHerbert Irving Comprehensive Cancer Center at Columbia University, New York, NY, USA.
Kevin KalinskyWinship Cancer Institute at Emory University, Atlanta, GA, USA.
Claudine IsaacsLombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, USA.
Delphine LoiratInstitut Curie, Paris, France.
Laura TestaInstituto D'Or de Pesquisa e Ensino (IDOR), São Paulo, Brazil.
Eriko TokunagaNational Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Jiong WuShanghai Cancer Center, Fudan University, Shanghai, China.
Hannah DryAstraZeneca, Waltham, MA, USA.
William BarlowCancer Research and Biostatistics, Seattle, WA, USA.
Robert KozarskiBiostatistics, AstraZeneca, Cambridge, UK.
Micah MaxwellLate Development - Oncology R&D, AstraZeneca, Gaithersburg, MD, USA.
Nadia HarbeckBreast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center (CCC) Munich, LMU University Hospital, Munich, Germany.ORCID https://orcid.org/0000-0002-9744-7372
Priyanka SharmaThe University of Kansas Medical Center, Kansas City, KS, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Despite advances in the treatment of early triple-negative breast cancer (TNBC), patients with residual invasive disease after neoadjuvant therapy have a high risk of disease recurrence and worse survival outcomes than those who have pathological complete response (pCR). Improving outcomes in early TNBC remains an unmet need requiring new adjuvant treatment approaches. Datopotamab deruxtecan (Dato-DXd) is an antibody-drug conjugate comprising a humanized anti-trophoblast cell-surface antigen 2 immunoglobulin G1 (IgG1) monoclonal antibody attached Objectives: TROPION-Breast03 is an ongoing phase III study evaluating the efficacy and safety of Dato-DXd alone or combined with durvalumab Methods and design: Eligible patients, aged ⩾18 years, will be randomized in a 2:1:2 ratio to receive Dato-DXd [6 mg/kg intravenously (IV) every 3 weeks (Q3W); eight cycles] and durvalumab (1120 mg IV Q3W; nine cycles), Dato-DXd monotherapy (6 mg/kg IV Q3W), or investigator's choice of therapy (ICT; capecitabine, pembrolizumab, or capecitabine and pembrolizumab). The primary endpoint is invasive disease-free survival (iDFS) for Dato-DXd and durvalumab Ethics: TROPION-Breast03 will be approved by the independent ethics committees or institutional review boards at each study site. All study participants will provide written informed consent. Discussion: TROPION-Breast03 will help define the potential role of Dato-DXd in the treatment of patients with early-stage TNBC who do not have pCR after neoadjuvant therapy. Trial registration: ClinicalTrials.gov identifier: NCT05629585 (registration date: 29 November 2022).

Indexed as

adjuvant therapyantibody–drug conjugatesimmunotherapyprogrammed cell death ligand-1triple-negative breast cancertrophoblast cell-surface antigen 2

Identifiers

PMID38686016
PMCPMC11057345

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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.