Evidence map›Paper›PMID 38384488›Full record

ArticleBreast care (Basel, Switzerland)2024

Neratinib as Extended Adjuvant Treatment of HER2-Positive/HR-Positive Early Breast Cancer Patients in Germany, Austria, and Switzerland: Interim Results of the Prospective, Observational ELEANOR Study.

Nadia Harbeck, Denise Wrobel, Matthias Zaiss, Jürgen Terhaag, Dagmar Guth, Andrea Distelrath, Mark-Oliver Zahn, Rachel Wuerstlein, Andreas Lorenz, Rupert Bartsch and 12 more

Open access · greenAbstract read
In one paragraph

Article in Breast care (Basel, Switzerland), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.2field-weighted citation impact, top 18% of its field
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

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. 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

22 authors at 15 institutions in 4 countries.

Nadia HarbeckDepartment of Obstetrics and Gynecology and CCC Munich, Breast Center, LMU University Hospital, Munich, Germany.
Denise WrobelSozialstiftung Bamberg Klinikum am Bruderwald, Bamberg, Germany.
Matthias ZaissPraxis fuer Interdisziplinaere Onkologie, Freiburg, Germany.
Jürgen TerhaagRottal/Inn Clinic Eggenfelden, Eggenfelden, Germany.
Dagmar GuthGyneco-Oncological Practice Dr. Guth, Plauen, Germany.
Andrea DistelrathPraxisgemeinschaft Onkologie und Urologie, Wilhelmshaven, Germany.
Mark-Oliver ZahnMVZ Onkologische Kooperation Harz, Goslar, Germany.
Rachel WuerstleinDepartment of Obstetrics and Gynecology and CCC Munich, Breast Center, LMU University Hospital, Munich, Germany.
Andreas LorenzGyneco-Oncological Practice Dr. Lorenz, Hildburghausen, Germany.
Rupert BartschDivision of Oncology, Department of Medicine I, Medical University of Vienna, Vienna, Austria.
Urs BreitensteinDivison of Oncology, Brust-Zentrum Zürich, Zurich, Switzerland.
Michael SchwitterKantonsspital Graubünden, Chur, Switzerland.
Marija BalicDivison of Oncology, Department of Internal Medicine, Medical University Graz, Graz, Austria.
Christian JackischDepartment of Gynecology and Obstetrics, Klinikum Offenbach, Offenbach, Germany.
Volkmar MüllerDepartment of Gynecology, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
Gabriel RinnerthalerDepartment of Internal Medicine III, Paracelsus Medical University Salzburg, Salzburg, Austria.
Marcus SchmidtDepartment of Gynecology, University Hospital Mainz, Mainz, Germany.
Khalil ZamanBreast Center, Lausanne University Hospital CHUV, Lausanne, Switzerland.
Timo SchinkötheCANKADO Service GmbH, Kirchheim, Germany.
Anna ReschPierre Fabre Pharma GmbH, Freiburg, Germany.
Roberta ValentiPierre Fabre Medicament, Boulogne, France.
Diana LüftnerImmanuel Hospital Märkische Schweiz & Medical University of Brandenburg Theodor-Fontane, Brandenburg, Germany.
Ludwig-Maximilians-Universität München · DEPraxis für Hämatologie und Onkologie · DEUniversität Hamburg · DEBreast Center · CHImmunologie-Zentrum Zürich · CHJohannes Gutenberg University Mainz · DEKantonsspital Graubünden · CHMedical University of Graz · ATMedical University of Vienna · ATParacelsus Medical University · ATPierre Fabre (France) · FRPierre Fabre (Germany) · DERoto Frank (Germany) · DEServiceplan (Germany) · DESozialstiftung Bamberg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Prognosis of patients diagnosed with HER2+ early breast cancer (eBC) has substantially improved, but distant recurrences impacting quality of life and survival still occur. One treatment option for extended adjuvant treatment of patients with HER2+/HR+ eBC is neratinib, available in Europe for patients who completed adjuvant trastuzumab-based therapy within 1 year. The ELEANOR study is investigating the real-world use of neratinib in Germany, Austria, and Switzerland. Results from an interim analysis of the first 200 patients observed for ≥3 months are reported. Methods: The primary objective of this prospective, multicenter, observational study is to assess patient adherence to neratinib (defined as the percentage of patients taking neratinib on ≥75% prescribed days). Secondary objectives are patient characteristics and treatment outcomes. Results: At cut-off (May 2, 2022), a total of 202 patients had been observed for ≥3 months, with neratinib treatment documented for 187 patients (median age: 53.0 years; 67.9% at increased risk of disease recurrence). In total, 151 (80.7%) patients had received prior neoadjuvant treatment; of these, 82 (54.3%) patients achieved a pathologically complete response. Neratinib was initiated at a median 3.6 months after trastuzumab-based treatment, with 36.4% starting at a dose <240 mg/day. Treatment is ongoing for 46.0% of patients, with median treatment duration of 11.2 (interquartile range 0.9-12.0) months. Diarrhea was the most common adverse event (78.6% any grade, 20.3% grade ≥3); pharmacologic prophylaxis was used in 85.6% of patients. Conclusions: The pattern of anti-HER2 pretreatment observed reflected the current treatment for HER2+/HR+ eBC in Germany, Austria, and Switzerland. These interim results suggest that neratinib as an extended adjuvant is a feasible option after various anti-HER2 pretreatments and that its tolerability can be managed and improved with proactive diarrhea management.

Indexed as

Early breast cancerExtended adjuvant treatmentHER2-positive breast cancerHR-positive breast cancerNeratinib

Identifiers

PMID38384488
PMCPMC10878708
OpenAlexW4387521781

What OpenQuestion holds

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LicenceCC BY-NC
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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.