Evidence map›Paper›PMID 40641449›Full record

Trial reportInternational journal of cancer2025

Invasive disease-free and overall survival after (neo)adjuvant chemotherapy in postmenopausal patients with hormone receptor-positive, HER2-negative early breast cancer treated with upfront letrozole: Experiences from the phase IV PreFace trial.

Milena Beierlein, Lothar Häberle, Naiba Nabieva, Nicolai Maass, Bahriye Aktas, Sherko Kümmel, Christoph Thomssen, Christopher Wolf, Hans-Christian Kolberg, Cosima Brucker and 34 more

Registry-linked trialAbstract readClinical Trial, Phase IV
In one paragraph

Trial report in International journal of cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01908556 (Open Labeled, Propective, Multicentric Phase IV Study to Examine the Influence of Pharmacogenetic Markers on the Efficacy and Side Effects in Postmenopausal, Steroid Hormone Positive Breast Cancer Patients, Who Are Treated With Letrozol.), which is not on this 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.

NCT01908556 phase4unknown statusnot on this map

Open Labeled, Propective, Multicentric Phase IV Study to Examine the Influence of Pharmacogenetic Markers on the Efficacy and Side Effects in Postmenopausal, Steroid Hormone Positive Breast Cancer Patients, Who Are Treated With Letrozol.

TypeinterventionalSponsorInstitut fuer FrauengesundheitRan2009Enrolled3,545Conditionsis to Identify Biomarkers That Could Predict the Efficacy of an Adjuvant Letrozol Treatment in Postmenopausal Breast Cancer Patients.ArmsLetrozole
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
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

44 authors.

Milena BeierleinDepartment of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Lothar HäberleDepartment of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.ORCID 0000-0003-4019-9328
Naiba NabievaDepartment of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Nicolai MaassDepartment of Gynecology and Obstetrics, University Hospital of Schleswig-Holstein, Campus Kiel, Kiel, Germany.
Bahriye AktasDepartment of Gynecology, University Hospital Leipzig, Leipzig, Germany.
Sherko KümmelBreast Unit, Kliniken Essen-Mitte, Essen, Germany.
Christoph ThomssenDepartment of Gynaecology, Martin-Luther-University Halle-Wittenberg, Halle (Saale), Germany.
Christopher WolfMedical Center Ulm, Ulm, Germany.
Hans-Christian KolbergDepartment of Gynecology and Obstetrics, Marienhospital Bottrop, Bottrop, Germany.
Cosima BruckerDepartment of Gynecology and Obstetrics, University Hospital, Paracelsus Medical University, Nuremberg, Germany.
Wolfgang JanniDepartment of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Germany.
Peter DallDepartment of Gynecology, Lüneburg Clinic, Lüneburg, Germany.
Andreas SchneeweissDivision of Gynecologic Oncology, National Center for Tumor Diseases, University Hospital and German Cancer Research Center, Heidelberg, Germany.
Frederik MarmeDepartment of Gynecology and Obstetrics, University Medical Centre Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.
Marc W SütterlinDepartment of Gynecology and Obstetrics, University Medical Centre Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.
Matthias RuebnerDepartment of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Anna-Katharin TheuserInstitut für Frauengesundheit GmbH, Erlangen, Germany.
Nadine M HofmannInstitut für Frauengesundheit GmbH, Erlangen, Germany.
Sybille BöhmInstitut für Frauengesundheit GmbH, Erlangen, Germany.
Katrin AlmstedtDepartment of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Sara KellnerDepartment of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Paul GassDepartment of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.ORCID 0000-0002-4239-5528
Hans-Joachim LückGynäkologisch-Onkologische Praxis Hannover, Hannover, Germany.
Alexander HeinDepartment of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Sabine SchmatlochElisabeth Krankenhaus Kassel, Kassel, Germany.
Matthias KalderDepartment of Gynecology and Obstetrics, University Hospital Gießen and Marburg, Marburg, Germany.
Christoph UleerGyn.-onkologische Gemeinschaftspraxis Hildesheim, Hildesheim, Germany.
Ingolf Juhasz-BössDepartment of Obstetrics and Gynecology, Freiburg University Hospital, Freiburg, Germany.
Volker HanfFrauenklinik, Klinikum Fürth, Fürth, Germany.
Christian JackischFrauenklinik Sana Klinikum, Offenbach, Germany.
Volkmar MüllerDepartment of Gynecology, Hamburg-Eppendorf University Medical Center, Hamburg, Germany.
Brigitte RackDepartment of Gynecology and Obstetrics, Ulm University Hospital, Ulm, Germany.
Erik BellevilleClinSol GmbH & Co. KG, Würzburg, Germany.
Diethelm WallwienerDepartment of Obstetrics and Gynecology, University of Tuebingen, Tuebingen, Germany.
Achim RodyDepartment of Gynecology and Obstetrics, University Hospital Schleswig-Holsteinm, Campus Lübeck, Lübeck, Germany.
Claudia RauhDepartment of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Chistian M BayerDepartment of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Sabrina UhrigDepartment of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Hanna HuebnerDepartment of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Chloë GoossensDepartment of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.ORCID 0009-0009-2809-8082
Sara Y BruckerDepartment of Obstetrics and Gynecology, University of Tuebingen, Tuebingen, Germany.
Carolin C HackDepartment of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Tanja N FehmDepartment of Gynecology and Obstetrics, University Hospital Düsseldorf, Düsseldorf, Germany.
Peter A FaschingDepartment of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.

Funding

Novartis Deutschland GmbH
6 · The paper itself

Abstract

Patients with hormone receptor-positive (HRpos), HER2-negative (HER2neg) breast cancer (BC) benefit less from neoadjuvant chemotherapy (NACT) than patients with triple-negative and HER2-positive BC. In this retrospective analysis of the phase IV PreFace clinical trial (NCT01908556), where postmenopausal HRpos BC patients (n = 3297) were treated with 5-year upfront adjuvant letrozole therapy, we evaluated the prognosis of patients treated with adjuvant versus neoadjuvant chemotherapy in HRpos/HER2neg early-stage BC. HRpos/HER2neg patients with information on (neo)adjuvant chemotherapy (n = 2895) were retrospectively selected from all patients enrolled in the PreFace trial. Invasive disease-free survival (iDFS) and overall survival (OS) were compared between patient groups that were treated with neoadjuvant or adjuvant chemotherapy. Chemotherapy was given to 1051 patients (36.3% of all patients), of which 874 (83.2%) received adjuvant chemotherapy and 177 (16.8%) NACT. Pathologic complete response (pCR) rate in the NACT group was 6.9%. Patients treated with NACT had a worse outcome than those treated with adjuvant chemotherapy (5-year iDFS rate 81% vs. 88%; 5-year OS rate 89% vs. 93%). This effect was maintained after adjusting for age, BMI, lymph node status, grading, tumor size, and histology (hazard ratio for iDFS: 1.95 (95%CI: 1.28-2.95); hazard ratio for OS: 2.13 (95%CI: 1.24-3.66)). Further adjustment for taxane-based regimes did not alter results. In conclusion, in this retrospective analysis of patients with early-stage HRpos/HER2neg BC, patients with NACT had a more unfavorable prognosis than patients treated adjuvantly, independent of patient and tumor characteristics. Prognosis of neoadjuvant patients might be affected by resistance mechanisms, warranting further investigation.

Indexed as

Breast NeoplasmsLetrozoleAdultAgedAntineoplastic Combined Chemotherapy ProtocolsChemotherapy, AdjuvantDisease-Free SurvivalErb-b2 Receptor Tyrosine KinasesFemaleHumansMiddle AgedNeoadjuvant TherapyPostmenopausePrognosisReceptors, EstrogenReceptors, ProgesteroneERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesLetrozoleReceptors, EstrogenReceptors, ProgesteroneTriazolesadjuvant chemotherapybreast cancerhormone receptor‐positive/HER2‐negativeneoadjuvant chemotherapyphase IV clinical trial

Identifiers

PMID40641449
PMCPMC12496005

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.