{
  "abstract": "Abemaciclib plus endocrine therapy (ET) is an established adjuvant treatment for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, high-risk early breast cancer (EBC), based on monarchE trial. Prospective real-world data on persistence, adherence, dose management, and patient-reported outcomes (PROs) remain lacking. IT-PATH was designed to address these gaps. IT-PATH is a prospective, multicenter, noninterventional study enrolling patients with HR-positive, HER2-negative high-risk EBC treated with adjuvant abemaciclib + ET at 18 Italian sites. This preplanned interim analysis reports data from the first 100 patients reaching 6-month follow-up. Primary outcome: 6-month treatment persistence and discontinuation rate. Secondary outcomes: adherence [modified medication possession ratio (mMPR)], dose management, safety. Exploratory endpoints (PROs): health-related quality of life (HRQoL), sexual health, and work productivity. Patients were 100% female, with a mean age of 55.4 years; 89.6% had Eastern Cooperative Oncology Group Performance Status 0. Treatment persistence at 3 months was 100% and at 6 months was 98% (median follow-up, 5.6 months). Discontinuation occurred in 2% due to adverse events (AEs). Reductions occurred in 52%; high adherence (mMPR ≥0.8 in 89.8%). AEs ≥ grade 3 were reported in 29% (no grade 4/5). Diarrhea (85%), asthenia (38%), and neutropenia (34%) were the most frequent AEs (any grade). No clinically meaningful changes from baseline were observed across all PROs. This interim analysis provides prospective real-world evidence that, in routine clinical practice, adjuvant abemaciclib + ET demonstrates feasibility and manageable tolerability with high treatment persistence and no clinically meaningful changes in HRQoL during the first 6 months of therapy. These findings support the value of proactive and personalized dose management to sustain treatment exposure and patient well-being.",
  "abstract_shown": true,
  "affiliations": [
    "Department of Experimental and Clinical Biomedical Sciences Mario Serio, University of Florence, Florence, Italy.",
    "Radiation Oncology Unit and Breast Unit, Department of Oncology, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.",
    "Department of Specialized Medical Sciences, Medical Oncology Unit, San Paolo Hospital, ASL Bari, Bari, Italy.",
    "Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori (INT), Milan, Italy.",
    "Department of Onco-Hematology, ASST Papa Giovanni XXIII, Bergamo, Italy.",
    "Division of Medical Oncology 1, Department of Oncology, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.",
    "Medical Oncology Unit, Istituto Oncologico Veneto IOV-IRCCS, Padua, Italy.",
    "Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy.",
    "Medical Oncology Unit, Ospedale Ca' Foncello, AULSS2 Marca Trevigiana, Treviso, Italy.",
    "Department of Medical Oncology, IRCCS Ospedale Policlinico San Martino, Genova, Italy.",
    "Research Unit in Medical Senology, Division of Medical Senology, Istituto Europeo di Oncologia (IEO), IRCCS, Milan, Italy.",
    "Medical Oncology Unit, Humanitas Istituto Clinico Catanese, Misterbianco (Catania), Italy.",
    "Medical Oncology Unit, Presidio Sanitario Ospedale Cottolengo, Turin, Italy.",
    "Medical Oncology Unit, Azienda Ospedaliera San Giovanni Addolorata, Rome, Italy.",
    "Unit of Precision Medicine in Breast Cancer, Department of Women's, Children's and Public Health Sciences, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.",
    "Department of Medical Oncology, Centro di Riferimento Oncologico (CRO) di Aviano, IRCCS, Aviano (PN), Italy.",
    "Department of Medicine (DAME), University of Udine, Udine, Italy.",
    "Oncology Department, Azienda Ospedaliera \"Cardinale G. Panico\", Tricase (LE), Italy.",
    "Medical Oncology Department, Azienda Ospedaliero-Universitaria Policlinico di Modena, Modena, Italy.",
    "Eli Lilly Italia S.p.A., Sesto Fiorentino (FI), Italy.",
    "Division of Breast Medical Oncology, Department of Breast and Thoracic Oncology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli, Italy."
  ],
  "article_type": null,
  "arxiv": null,
  "author_total": 20,
  "authors": [
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      "name": "V Guarneri"
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      "name": "M A Sarno"
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        20
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      "name": "M De Laurentiis"
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  ],
  "bibtex": "https://research.draconitic.com/paper/8gqhb86jcnvff.bib",
  "cited_by": 0,
  "doi": "10.1016/j.esmorw.2026.100813",
  "fulltext_url": "https://europepmc.org/articles/PMC13743471",
  "id": "8gqhb86jcnvff",
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  "language": "eng",
  "licence": "CC-BY-NC-ND",
  "licence_label": "CC BY-NC-ND",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nc-nd/4.0/",
  "metadata_licence": null,
  "native_subjects": [
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      "2730|Advanced Breast Cancer Therapies"
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  "pdf_url": "https://europepmc.org/articles/PMC13743471?pdf=render",
  "pmcid": "PMC13743471",
  "pmid": "42999618",
  "published": "2026-10-29",
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  "ris": "https://research.draconitic.com/paper/8gqhb86jcnvff.ris",
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  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2730|Advanced Breast Cancer Therapies",
      "subfield": "oncology"
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  ],
  "title": "Abemaciclib plus endocrine therapy in high-risk, node-positive early breast cancer in Italian practice: interim analysis of prospective observational IT-PATH study.",
  "title_text": "Abemaciclib plus endocrine therapy in high-risk, node-positive early breast cancer in Italian practice: interim analysis of prospective observational IT-PATH study.",
  "type": "peer-reviewed",
  "updated_at": "2026-11-09T15:20:34Z",
  "url": "https://research.draconitic.com/paper/8gqhb86jcnvff",
  "venue": "ESMO real world data and digital oncology",
  "versions": []
}