Evidence map›Paper›PMID 41999684›Full record

ArticleBreast (Edinburgh, Scotland)2026

Integrating PIK3CA Testing into Clinical Practice for Advanced HR+/HER2- Breast Cancer: An Expert Consensus.

Carmine De Angelis, Dario de Biase, Lorenzo Gerratana, Grazia Arpino, Giampaolo Bianchini, Isabella Castellano, Giuseppe Curigliano, Lucia Del Mastro, Alessandra Fabi, Nicola Fusco and 6 more

Abstract readConsensus Statement
PubMed Full text at PMC Publisher
In one paragraph

Article in Breast (Edinburgh, Scotland), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

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

2 citing papers in PubMed.

  1. The journal of liquid biopsy · 2026
    Review
  2. Liquid biopsy in solid tumours: expert opinion paper of the European society of pathology.Virchows Archiv : an international journal of pathology · 2026
    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

16 authors.

Carmine De AngelisDepartment of Breast and Thoracic Oncology, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale, Via Mariano Semmola, 52, Napoli 80131, Italy; Clinical and Translational Oncology, Scuola Superiore Meridionale, Naples, Italy. Electronic address: c.deangelis@ssmeridionale.it.
Dario de BiaseSolid Tumor Molecular Pathology Laboratory, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; Department of Pharmacy and Biotechnology (FaBit), University of Bologna, Bologna, Italy.
Lorenzo GerratanaDepartment of Medical Oncology, Centro di Riferimento Oncologico di Aviano (CRO), National Cancer Institute, IRCCS, Aviano, Italy; Department of Medicine, University of Udine, Udine, Italy.
Grazia ArpinoDipartimento di Medicina Clinica e Chirurgia Federico II, Naples, Italy; Institute for Cancer Research and Molecular Medicine, Temple University, Philadelphia, USA.
Giampaolo BianchiniDepartment of Medical Oncology, IRCCS Ospedale San Raffaele, Milan, Italy; Università Vita-Salute San Raffaele, Milan, Italy.
Isabella CastellanoPathology Unit, Department of Medical Sciences, City of Health, Turin, Italy; Science University Hospital, University of Turin, Turin, Italy.
Giuseppe CuriglianoEuropean Institute of Oncology, IRCCS, Milan, Italy; Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.
Lucia Del MastroIRCSS Ospedale Policlinico San Martino, UO Clinica Oncologia Medica, Genoa, Italy; Department of Internal Medicine and Medical Specialties (DIMI), Università di Genova, Genoa, Italy.
Alessandra FabiPrecision Medicine Unit in Senology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Nicola FuscoDepartment of Oncology and Hemato-Oncology, University of Milan, Milan, Italy; Division of Pathology, European Institute of Oncology IRCCS, Milan, Italy.
Alessandra GennariDepartment of Translational Medicine, University of Piemonte Orientale, Novara, Italy; Division of Medical Oncology, Maggiore University Hospital, Novara, Italy.
Valentina GuarneriOncology 2, Veneto Institute of Oncology, IOV-IRCCS, Padua, Italy; Department of Surgery, Oncology, and Gastroenterology, University of Padua, Padua, Italy.
Claudio ZamagniIRCCS Azienda Ospedaliero Universitaria di Bologna, Bologna, Italy.
Alberto ZambelliOncology Unit, ASST Papa Giovanni XXIII, Bergamo, Italy; Department of Medicine and Surgery, Università Degli Studi di Milano Bicocca, Milan, Italy.
Umberto MalapelleDepartment of Public Health, University Federico II of Naples, Naples, Italy.
Fabio PuglisiDepartment of Medical Oncology, Centro di Riferimento Oncologico di Aviano (CRO), National Cancer Institute, IRCCS, Aviano, Italy; Department of Medicine, University of Udine, Udine, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlterations in the PI3K/AKT/mTOR signaling pathway represent a mechanism of resistance to endocrine therapy in advanced HR+/HER2-breast cancer. The identification of activating mutations in PIK3CA has gained therapeutic relevance, guiding the use of PIK3CA-targeted inhibitors such as alpelisib and inavolisib.

methodsA multidisciplinary panel of Italian experts conducted a structured consensus process to develop shared recommendations for molecular testing of PIK3CA in advanced HR+/HER2-breast cancer, addressing preanalytical, analytical, and clinical-therapeutic areas of concern.

resultsA total of 23 out of 29 statements reached complete agreement (100%). The resulting recommendations encompass sample selection, analytical methodologies, sensitivity thresholds, result reporting, and clinical interpretation and integration. Additional guidance is provided for the management of non-canonical gene variants and for other genes involved in the PI3K/AKT/mTOR pathway.

conclusionsThis consensus document provides operational and interpretative guidelines aimed at standardizing PIK3CAtesting and assessing related genes in clinical practice. These recommendations promote a harmonized approach to patient care, in line with the latest scientific evidence.

Indexed as

Breast NeoplasmsClass I Phosphatidylinositol 3-KinasesErb-b2 Receptor Tyrosine KinasesFemaleHumansItalyMutationReceptors, EstrogenReceptors, ProgesteroneTOR Serine-Threonine KinasesClass I Phosphatidylinositol 3-KinasesERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesPIK3CA protein, humanReceptors, EstrogenReceptors, ProgesteroneTOR Serine-Threonine KinasesExpert consensusHR+/HER2− breast cancerLiquid biopsyNGSPIK3CA

Identifiers

PMID41999684
PMCPMC13101763

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.