Evidence map›Paper›PMID 31134488›Full record

Trial reportBreast cancer research and treatment2019

Dissecting the effect of hormone receptor status in patients with HER2-positive early breast cancer: exploratory analysis from the ALTTO (BIG 2-06) randomized clinical trial.

Matteo Lambertini, Christine Campbell, Richard D Gelber, Giuseppe Viale, Ann McCullough, Florentine Hilbers, Larissa A Korde, Olena Werner, Saranya Chumsri, Christian Jackisch and 8 more

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Breast cancer research and treatment, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  20. Regulatory Effect of miR497-5p-Cancer management and research · 2021
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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.

Matteo LambertiniDepartment of Medical Oncology, U.O.C. Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi 10, 16132, Genova, Italy. matteo.lambertini@unige.it.ORCID http://orcid.org/0000-0003-1797-5296
Christine CampbellFrontier Science, Kingussie, UK.
Richard D GelberDana-Farber Cancer Institute, Harvard Medical School, Harvard TH Chan School of Public Health and Frontier Science and Technology Research Foundation, Boston, MA, USA.
Giuseppe VialeIEO, European Institute of Oncology IRCCS, University of Milan, Milan, Italy.
Ann McCulloughMayo Clinic, Phoenix, AZ, USA.
Florentine HilbersBreast International Group, Brussels, Belgium.
Larissa A KordeNational Cancer Institute, Bethesda, MD, USA.
Olena WernerNovartis Pharma AG, Basel, Switzerland.
Saranya ChumsriMayo Clinic, Jacksonville, FL, USA.
Christian JackischSana Klinikum Offenbach, Offenbach, Germany.
Antonio C WolffJohns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA.
Ines Vaz-LuisInstitut Gustave Roussy, Villejuif, France.
Arlindo R FerreiraChampalimaud Clinical Center, Champalimaud Foundation and Instituto de Medicina Molecular, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal.
Aleix PratDepartment of Medical Oncology, Hospital Clínic of Barcelona, Barcelona, Spain.
Alvaro Moreno-AspitiaMayo Clinic, Jacksonville, FL, USA.
Martine PiccartInstitut Jules Bordet and Université Libre de Bruxelles (U.L.B.), Brussels, Belgium.
Sherene LoiPeter MacCallum Cancer Centre, University of Melbourne, Melbourne, Australia.
Evandro de AzambujaInstitut Jules Bordet and Université Libre de Bruxelles (U.L.B.), Brussels, Belgium.

Funding

Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Statistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$115.0M
TRANSLATIONAL RESEARCHU10CA025224 · NCI · MAYO CLINIC ROCHESTER · PI BUCKNER, JAN C · 1985 to 2013
$85.0M
NCI NIH HHS U10 CA025224NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180882
6 · The paper itself

Abstract

purposeLimited evidence exists on the impact of hormone receptor (HR) status to counsel HER2-positive early breast cancer patients receiving adjuvant anti-HER2 therapy.

methodsALTTO (BIG 2-06) was an international, intergroup, open-label, randomized phase III trial in HER2-positive early breast cancer patients randomized to receive 1 year of trastuzumab and/or lapatinib. HER2, estrogen and progesterone receptors were centrally tested for all patients. We investigated the impact of HR status on prognosis, risk of disease-free survival (DFS) events over time, patterns of first DFS events, and factors associated with risk of DFS events overall, in years 0-5 and 6-8.

resultsOut of 6273 patients included in this analysis, 3603 (57.4%) had HR-positive tumors. Median follow-up was 6.93 years. Five-year and 8-year DFS were 86% and 80% in patients with HR-positive disease, and 83% and 79% in those with HR-negative tumors, respectively. Mean annual hazards of recurrence in years 0-5 were 3% in patients with HR-positive disease and 4% in those with HR-negative tumors, while in years 6-8 they were 3% and 2%, respectively. Distribution of first DFS event in years 6-8 (P = 0.005) and type of first distant recurrence (P < 0.001) were significantly different between the two groups. Risk factors for DFS events overall, in years 0-5, and 6-8 were different in patients with HR-positive and HR-negative tumors.

conclusionsHER2-positive early breast cancer is characterized by the presence of two diseases with distinct natural history based on HR status requiring the development of different follow-up strategies and future de-escalation and escalation clinical trials.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsChemotherapy, AdjuvantDisease-Free SurvivalErb-b2 Receptor Tyrosine KinasesFemaleHumansMolecular Targeted TherapyProportional Hazards ModelsReceptors, ProgesteroneTreatment OutcomeErb-b2 Receptor Tyrosine KinasesReceptors, ProgesteroneBreast cancerEstrogen receptorHER2Progesterone receptor

Identifiers

PMID31134488
PMCPMC13612158

What OpenQuestion holds

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Registered trials

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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.