Evidence map›Paper›PMID 38003555›Full record

ArticleInternational journal of molecular sciences2023

The Clinical Relevance of the NATALEE Study: Application of the NATALEE Criteria to a Real-World Cohort from Two Large German Breast Cancer Centers.

Henning Schäffler, Franziska Mergel, Kerstin Pfister, Stephan Lukac, Angelina Fink, Kristina Veselinovic, Brigitte Rack, Visnja Fink, Elena Leinert, Moritz Dimpfl and 13 more

Open access · goldAbstract read
In one paragraph

Article in International journal of molecular sciences, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
8.0field-weighted citation impact, top 2% 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

19 citing papers in PubMed, 31 citations in OpenAlex.

  1. Review
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  3. Eligibility for adjuvant CDK4/6 inhibitors in HR+/HER2- early breast cancer: insights from a large cohort in central south China.Translational breast cancer research : a journal focusing on translational research in breast cancer · 2026
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  8. Therapy of early breast cancer: current status and perspectives.Archives of gynecology and obstetrics · 2025
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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

23 authors at 4 institutions in 1 country.

Henning SchäfflerDepartment of Gynecology and Obstetrics, University Hospital Ulm, 89075 Ulm, Germany.
Franziska MergelDepartment of Gynecology and Obstetrics, University Hospital Ulm, 89075 Ulm, Germany.
Kerstin PfisterDepartment of Gynecology and Obstetrics, University Hospital Ulm, 89075 Ulm, Germany.
Stephan LukacDepartment of Gynecology and Obstetrics, University Hospital Ulm, 89075 Ulm, Germany.
Angelina FinkDepartment of Gynecology and Obstetrics, University Hospital Ulm, 89075 Ulm, Germany.
Kristina VeselinovicDepartment of Gynecology and Obstetrics, University Hospital Ulm, 89075 Ulm, Germany.
Brigitte RackDepartment of Gynecology and Obstetrics, University Hospital Ulm, 89075 Ulm, Germany.
Visnja FinkDepartment of Gynecology and Obstetrics, University Hospital Ulm, 89075 Ulm, Germany.
Elena LeinertDepartment of Gynecology and Obstetrics, University Hospital Ulm, 89075 Ulm, Germany.
Moritz DimpflDepartment of Gynecology and Obstetrics, University Hospital Mannheim, 68135 Mannheim, Germany.ORCID 0000-0001-6202-7397
Alexander EnglischDepartment of Women's Health, Tuebingen University, 72076 Tuebingen, Germany.
Christian Martin TegelerDepartment of Women's Health, Tuebingen University, 72076 Tuebingen, Germany.ORCID 0000-0001-6688-7351
Anna SellerDepartment of Women's Health, Tuebingen University, 72076 Tuebingen, Germany.
Eva-Maria GrischkeDepartment of Women's Health, Tuebingen University, 72076 Tuebingen, Germany.
Markus HahnDepartment of Women's Health, Tuebingen University, 72076 Tuebingen, Germany.
Léa Louise VolmerDepartment of Women's Health, Tuebingen University, 72076 Tuebingen, Germany.
Tobias EnglerDepartment of Women's Health, Tuebingen University, 72076 Tuebingen, Germany.ORCID 0000-0002-8063-2053
Marie Louise FrevertDepartment of Obstetrics and Gynecology, University of Freiburg, 79106 Freiburg, Germany.
Florin Andrei TaranDepartment of Obstetrics and Gynecology, University of Freiburg, 79106 Freiburg, Germany.ORCID 0000-0001-7384-2928
Wolfgang JanniDepartment of Gynecology and Obstetrics, University Hospital Ulm, 89075 Ulm, Germany.
Sara Yvonne BruckerDepartment of Women's Health, Tuebingen University, 72076 Tuebingen, Germany.ORCID 0000-0001-5162-1542
Andreas Daniel HartkopfDepartment of Gynecology and Obstetrics, University Hospital Ulm, 89075 Ulm, Germany.ORCID 0000-0003-1227-1118
Dominik DannehlDepartment of Women's Health, Tuebingen University, 72076 Tuebingen, Germany.ORCID 0000-0002-7653-8283
University Hospital Ulm · DEUniversity of Tübingen · DEUniversity of Freiburg · DEHeidelberg University · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The NATALEE study showed a significant benefit in invasive disease-free survival (iDFS) for patients with HR+/HER2- early breast cancer (eBC) at intermediate and high risk of recurrence who were treated with the CDK4/6 inhibitor Ribociclib in combination with endocrine therapy (ET). This retrospective study aims to apply the NATALEE inclusion criteria to a representative real-world cohort to estimate the proportion of HR+/HER2- breast cancer patients eligible for adjuvant Ribociclib therapy. Patients who underwent full surgical treatment for eBC between January 2018 and December 2020 at two large German university breast cancer centers (University of Ulm, University of Tuebingen) were included. Descriptive statistics were used to characterize the patient population eligible for Ribociclib treatment based on the NATALEE study's inclusion criteria. Out of 2384 enrolled patients, 1738 had HR+/HER2- eBC, of whom 43% (747/1738) met the NATALEE inclusion criteria. Of note, these patients were older, received less chemotherapy and presented with less advanced tumor stages compared to the NATALEE study cohort. Additionally, compared to the NATALEE study cohort, fewer patients had lymph node involvement (72.4% vs. 88.7%). Our analysis suggests that approximately 43% of all HR+/HER2- breast cancer patients will qualify for Ribociclib treatment. Given the numerous treatment options for patients with HR+/HER2- eBC, as well as the differences between the NATALEE cohort and patients in the real-world clinical setting, future analyses will be needed to determine which patients would benefit most from adjuvant CDK4/6 inhibitor treatment.

Indexed as

Breast NeoplasmsAminopyridinesAntineoplastic Combined Chemotherapy ProtocolsClinical RelevanceErb-b2 Receptor Tyrosine KinasesFemaleHumansPurinesRetrospective StudiesAminopyridinesErb-b2 Receptor Tyrosine KinasesPurinesribociclibbreast cancerCDK4/6 InhibitorsNATALEEoncologyRibociclibsystemic therapy

Identifiers

PMID38003555
PMCPMC10671738
OpenAlexW4388696752

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.