Evidence map›Paper›PMID 40366335›Full record

ArticleThe oncologist2025

Decoding NATALEE and MonarchE eligibility criteria in a real-world cohort of early breast cancer patients.

Jacopo Canzian, Damiano Gentile, Rita De Sanctis, Flavia Jacobs, Chiara Benvenuti, Mariangela Gaudio, Riccardo Gerosa, Giuseppe Saltalamacchia, Rosalba Torrisi, Giovanna Masci and 2 more

Abstract read
In one paragraph

Article in The oncologist, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
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

12 authors.

Jacopo CanzianDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele, 20072 Milan, Italy.ORCID 0009-0008-0883-0582
Damiano GentileHumanitas Cancer Center, IRCCS Humanitas Research Hospital, Rozzano, 20089 Milan, Italy.ORCID 0000-0002-8861-5223
Rita De SanctisDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele, 20072 Milan, Italy.ORCID 0000-0003-3202-1933
Flavia JacobsHumanitas Cancer Center, IRCCS Humanitas Research Hospital, Rozzano, 20089 Milan, Italy.
Chiara BenvenutiDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele, 20072 Milan, Italy.
Mariangela GaudioDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele, 20072 Milan, Italy.ORCID 0000-0003-1004-2063
Riccardo GerosaDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele, 20072 Milan, Italy.
Giuseppe SaltalamacchiaHumanitas Cancer Center, IRCCS Humanitas Research Hospital, Rozzano, 20089 Milan, Italy.
Rosalba TorrisiHumanitas Cancer Center, IRCCS Humanitas Research Hospital, Rozzano, 20089 Milan, Italy.
Giovanna MasciHumanitas Cancer Center, IRCCS Humanitas Research Hospital, Rozzano, 20089 Milan, Italy.
Corrado TinterriDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele, 20072 Milan, Italy.
Alberto ZambelliDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele, 20072 Milan, Italy.ORCID 0000-0002-1374-1831

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The NATALEE trial expanded the use of adjuvant cyclin-dependent kinase 4/6 inhibitors beyond the MonarchE trial's criteria for early breast cancer (eBC). We conducted a retrospective analysis comparing a large real-world (RW) cohort of 762 consecutive eBC patients with those enrolled in the NATALEE and MonarchE randomized controlled trials (RCTs) to evaluate differences in eligibility. Our analysis revealed that 41.7% of RW patients met NATALEE's eligibility criteria, significantly more than the 21.8% who met MonarchE's criteria, reflecting NATALEE's broader indication. Real-world patients were older, had less advanced tumors, and were less likely to be treated with adjuvant chemotherapy compared to the RCT populations. None of the RW patients was deemed eligible for ribociclib based solely on high genomic risk. These findings underscore significant differences in clinical characteristics and potential treatment eligibility, highlighting the need for critical assessment of RCTs results in clinical practice.

Indexed as

Breast NeoplasmsAdultAgedAminopyridinesChemotherapy, AdjuvantCohort StudiesFemaleHumansMiddle AgedPurinesRandomized Controlled Trials as TopicRetrospective StudiesAminopyridinesPurinesribociclibadjuvant CDKiearly breast cancerNATALEE trialreal-worldrecurrence score

Identifiers

PMID40366335
PMCPMC12076640

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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.