Evidence map›Paper›PMID 40536732›Full record

Observational studyJournal of cancer research and clinical oncology2025

The efficacy and therapy management of nab-paclitaxel in the real-world setting for patients with advanced breast cancer - the SERAPHINA study.

Andreas Schneeweiss, Peter A Fasching, Marc Thill, Marion van Mackelenbergh, Frederik Marme, Hans Tesch, Tanja N Fehm, Tjoung-Won Park-Simon, Lothar Häberle, Sabrina Uhrig and 8 more

Registry-linked trialAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Journal of cancer research and clinical oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02642406 (Safety, Efficacy and Patient Reported Outcomes of Advanced Breast Cancer Patients), which is not on this 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.

NCT02642406 unknown statusnot on this map

Safety, Efficacy and Patient Reported Outcomes of Advanced Breast Cancer Patients: Therapy Management With Nab-Paclitaxel in Daily Routine - SERAPHINA

TypeobservationalSponsorUniversity Hospital TuebingenRan2015 to 2021Enrolled1,200ConditionsMetastatic Breast Cancer
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. 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

18 authors.

Andreas SchneeweissNational Center for Tumor Diseases (NCT), University Hospital and German Cancer Research Center, Heidelberg, Germany.
Peter A FaschingDepartment of Gynecology and Obstetrics, Universitätsklinikum Erlangen, Friedrich- Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany. peter.fasching@fau.de.
Marc ThillDepartment of Gynecology and Gynecological Oncology, AGAPLESION MARKUS KRANKENHAUS, Frankfurt, Germany.
Marion van MackelenberghDepartment of Gynecology and Obstetrics, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.
Frederik MarmeDepartment of Gynecology and Obstetrics, University Hospital Mannheim, Mannheim, Germany.
Hans TeschOncology Practice, Bethanien Hospital, Frankfurt am Main, Germany.
Tanja N FehmDepartment of Gynecology and Obstetrics, University Hospital Düsseldorf, Düsseldorf, Germany.
Tjoung-Won Park-SimonDepartment of Gynecology and Obstetrics, Hannover Medical School, Hannover, Germany.
Lothar HäberleDepartment of Gynecology and Obstetrics, Universitätsklinikum Erlangen, Friedrich- Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.
Sabrina UhrigDepartment of Gynecology and Obstetrics, Universitätsklinikum Erlangen, Friedrich- Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.
Oliver TomeDepartment of Gynecology and Obstetrics, St. Vincentius-Kliniken gAG , Karlsruhe, Germany.
Thomas SpallClinSol GmbH & Co KG, Würzburg, Germany.
Anna-Katharin TheuserInstitut für Frauengesundheit GmbH, Erlangen, Germany.
Matthias RuebnerDepartment of Gynecology and Obstetrics, Universitätsklinikum Erlangen, Friedrich- Alexander-Universität Erlangen-Nürnberg (FAU), Erlangen, Germany.
Erik BellevilleClinSol GmbH & Co KG, Würzburg, Germany.
Diethelm WallwienerDepartment of Gynecology and Obstetrics, University Hospital Tübingen, Tübingen, Germany.
Sara Y BruckerDepartment of Gynecology and Obstetrics, University Hospital Tübingen, Tübingen, Germany.
Andreas D HartkopfDepartment of Gynecology and Obstetrics, University Hospital Tübingen, Tübingen, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChemotherapies are still widely used in advanced breast cancer, specifically in patients with HER2-negative disease. This non-interventional real-world study assessed the utilization of nab-paclitaxel in a broad patient population with advanced breast cancer.

methodsSERAPHINA (NCT02642406) was a single arm, non-interventional study performed in Germany. Patients were eligible if they were treated with nab-paclitaxel according to the Summary of Product Characteristics (SmPC) as indicated by their physician. Progression-free survival (PFS), overall survival (OS), safety and quality of life were evaluated. Additionally, efficacy was assessed in patient subgroups based on age, metastasis pattern, performance status and therapy line.

resultsA total of 432 patients were treated with nab-paclitaxel. The majority of patients had HER2-negative disease (94.2%). Furthermore, 30.1% of patients were treated in the first line and 48.3% in the third or later therapy line. Median PFS was 6.0 months (95% CI: 5.6-6.9) and median OS was 15.3 months (95% CI: 12.5-17.5). Although no clear predictors of PFS and OS in multivariable Cox models could be identified, patients with brain metastases had the shortest PFS (3.0 months; 95% CI: 2.2-4.3). Adverse events occurred in 83.1% of patients, with high-grade adverse events being rare (< 8% of patients). Quality of life did not change under therapy.

conclusionNab-paclitaxel is used in patients with advanced breast cancer. In this real-world, non-interventional study, prognosis was favorable and safety profile manageable, which is comparable to previous clinical trials and real-world studies.

Indexed as

AlbuminsAntineoplastic Agents, PhytogenicBreast NeoplasmsPaclitaxelAdultAgedAged, 80 and overFemaleHumansMiddle AgedProgression-Free SurvivalQuality of Life130-nm albumin-bound paclitaxelAlbuminsAntineoplastic Agents, PhytogenicPaclitaxelAdvanced breast cancerChemotherapyNab-paclitaxelNon-interventional studyReal-world

Identifiers

PMID40536732
PMCPMC12178961

What Socratic holds

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Registered trials

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 Socratic graph.