PRAEGNANT

Projects & Publications

Projects & Publications

PRAEGNANT projects

  • HRpos/HER2neg metastasized breast cancer
  • PRAEGNANT study inclusion, consent for individual scientific results to be shared with the treating physician
  • Patients are scheduled to begin a new therapy, and the decision regarding that therapy has not yet been made (regardless of the reason, whether disease progression, side effects, or other reasons)
  • The most recent treatment must be one of the following: Endocrine therapy or chemotherapy following treatment with at least one endocrine therapy
  • Initiation of second- or third-line endocrine therapy
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PRAEGNANT Publications

Publications

Please click on the year to see the publications

2025
  • Walter CB et al. (2025), Characteristics and prognosis of patients with primary metastatic disease vs. recurrent HER2-negative, hormone receptor-positive advanced breast cancer. Breast. 2025 Apr;80:104412. doi: 10.1016/j.breast.2025.104412. Epub 2025 Feb 5. PMID: 39952220; PMCID: PMC11872390.
  • Michel L et al. (2025), Prognostic impact of the choice of chemotherapy after first-line CDK4/6 inhibitor therapy in patients with metastatic hormone receptor-positive, HER2-negative breast cancer. Eur J Cancer. 2025 Sep 9;227:115689. doi: 10.1016/j.ejca.2025.115689. Epub 2025 Aug 5. PMID: 40780076.
2024
  • Hartkopf W et al (2024), Attrition in the First Three Therapy Lines in Patients with Advanced Breast Cancer in the German Real World PRAEGNANT Registry. Geburtshilfe Frauenheilkd. 2024 May 29;84(5):459-469. doi: 10.1055/a-2286-5372. PMID: 38817595; PMCID: PMC11136529.
  • Fasching PA et al. (2024), Susceptibility gene mutations in germline and tumors of patients with HER2-negative advanced breast cancer. NPJ Breast Cancer. 2024 Jul 13;10(1):57. doi: 10.1038/s41523-024-00667-x. PMID: 39003306; PMCID: PMC11246424.
  • Huebner H et al. (2024), Cell-free tumor DNA analysis in advanced or metastatic breast cancer patients: mutation frequencies, testing intention, and clinical impact. Precis Clin Med. 2024 Dec 24;8(1):pbae034. doi: 10.1093/pcmedi/pbae034. PMID: 39839709; PMCID: PMC11748133.
  • Ziegler P et al. (2024), The impact of physical activity on progression-free and overall survival in metastatic breast cancer based on molecular subtype. BMC Cancer. 2024 Oct 16;24(1):1284. doi: 10.1186/s12885-024-13038-3. PMID: 39415149; PMCID: PMC11481816.
2023
  • Müller et al. (2023), Systemic Therapy of Premenopausal Patients with Early Stage Hormone Receptor-Positive, HER2-Negative Breast Cancer –
    Controversies and Standards in Healthcare, Geburtshilfe Frauenheilkd. 2023 May 23;83(6):673-685, PMCID: PMC10442909
  • Huebner et al. (2023), Return of individual genomic research results within the PRAEGNANT multicenter according to patient and tumor characteristics –
    a retrospective analysis of a real registry study, Breast Cancer Res Treat. 2023 Jan;197(2):355-368, PMCID: PMC9822879
2022
  • Müller et al. (2022), Occurrence and characteristics of patients with de novo advanced breast cancer world registry, Eur J Cancer. 2022 Sep:172:13-21, DOI: 10.1016/j.ejca.2022.05.015
  • Engler et al. (2022), Implementation of CDK4/6 Inhibitors and its Influence ot the Treatment Landscape of Advanced Breast Cancer Patients –
    Data from the Real-World Registry PRAEGNANT, Geburtshilfe Frauenheilkd. 2022 Jul 12;82(10):1055-1067, PMCID:PMC9525148
2021
  • Hein et al. (2021), Prognostic effect of low-level HER2 expression in patients with clinically negative HER2 status,
    Eur J Cancer. 2021 Sep:155:1-12, DOI: 10.1016/j.ejca.2021.06.033
  • Fasching PA et al. (2021), Mutations in BRCA1/2 and Other Panel Genes in Patients With Metastatic Breast Cancer –
    Association With Patient and Disease Characteristics and Effect on Prognosis, J Clin Oncol. 2021 May 20;39(15):1619-1630, PMCID: PMC8274805
2020
  • Schneeweiss A, Ettl J et al. (2020), Initial experience with CDK4/6 inhibitor-based therapies compared to antihormone monotherapies in routine
    clinical use in patients with hormone receptor positive, HER2 negative breast cancer – Data from the PRAEGNANT research network for the first
    2 years of drug availability in Germany, Breast. 2020 Dec:54:88-95, PMCID: PMC7509062
  • Huebner H et al. (2020), Heregulin (HRG) assessment for clinical trial eligibility testing in a molecular registry (PRAEGNANT) in Germany,
    BMC Cancer. 2020 Nov 11;20(1):1091, PMCID: PMC7656772
  • Laakmann E et al. (2020), Treatment landscape and prognosis after treatment with trastuzumab Emtansine, Geburtshilfe Frauenheilkd.
    2020 Nov 6;80(11):1134-1142, doi: 10.1055/a-1286-2917
  • Michel L et al. (2020), Progression-free survival and overall survival in patients with advanced HER2-positive breast cancer treated with
    Trastuzumab Emtansine (T-DM1) after previous treatment with pertuzumab, Cancers (Basel). 2020 Oct 17;12(10):3021, doi: 10.3390/cancers12103021
2019
  • Fasching PA, Hartkopf AD et al. (2019), Efficacy of neoadjuvant pertuzumab in addition to chemotherapy and trastuzumab in routine clinical treatment
    of patients with primary breast cancer: a multicentric analysis, Breast Cancer Res Treat. 2019 Jan;173(2):319-328,
    DOI: 10.1007/s10549-018-5008-3
2018
  • Lux MP, Nabieva N et al. (2018), Therapy Landscape in Patients with Metastatic HER2-Positive Breast Cancer: Data from the PRAEGNANT Real-World Breast
    Cancer Registry, Cancers (Basel). 2018 Dec 21;11(1):10, doi: 10.3390/cancers11010010
  • Hartkopf AD, Huober J et al. (2018), Treatment landscape of advanced breast cancer patients with hormone receptor positive HER2 negative tumors –
    Data from the German PRAEGNANT breast cancer registry, Breast. 2018 Feb;37:42-51, DOI: 10.1016/j.breast.2017.10.002
  • Müller V, Wallwiener M et al. (2018), Impact of disease progression on health-related quality of life in patients with metastatic breast cancer in the
    PRAEGNANT breast cancer registry, Breast. 2018 Feb:37:154-160, DOI: 10.1016/j.breast.2017.08.008
2017
  • Yinchong Yang et al. (2017), Modeling Progression Free Survival in Breast Cancer with Tensorized Recurrent Neural Networks and Accelerated Failure Time Model,
    Proceedings of the 2nd Machine Learning for Healthcare Conference, PMLR 68:164-176, 2017, https://proceedings.mlr.press/v68/yang17a.html
  • Fremd C et al. (2017), Use of complementary and integrative medicine among German breast cancer patients: predictors and implications for patient care
    within the PRAEGNANT study network, Arch Gynecol Obstet. 2017 May;295(5):1239-1245, DOI: https://doi.org/10.1007/s00404-017-4348-2
  • Wallwiener et al. (2017), Implementation and Feasibility of Electronic Patient-Reported Outcome (ePRO) Data Entry in the PRAEGNANT Real-Time Advanced and
    Metastatic Breast Cancer Registry, Geburtshilfe Frauenheilkd. 2017 Aug;77(8):870-878, PMCID: PMC5570586
  • Yinchong Yang et al. (2017), Predictive Modeling of Therapy Decisions in Metastatic Breast Cancer with Recurrent Neural Network Encoder and
    Multinomial Hierarchical Regression Decoder, IEEE International Conference on Healthcare Informatics (ICHI), Park City, UT, USA,
    2017, pp. 46-55, >Download paper
2016
  • Hein A et al. (2016), Computerized patient identification for the EMBRACA clinical trial using real-time data from the PRAEGNANT network for
    metastatic breast cancer patients, Breast Cancer Res Treat. 2016 Jul;158(1):59-65, DOI: 10.1007/s10549-016-3850-8
  • Yinchong Yang et al. (2016), Predictive Clinical Decision Support System with RNN Encoding and Tensor Decoding, >Download paper
2015
  • Fasching PA et al. (2015), Biomarkers in Patients with Metastatic Breast Cancer and the PRAEGNANT Study Network, Geburtshilfe Frauenheilkd. 2015 Jan;75(1):41-50, >Download paper
  • Yinchong Yang et al. (2015), Modeling Clinical Decisions with Multinomial Hierarchical
    Classification, Download paper
Please click on the year to see the publications
2025
  • Walter CB et al. (2025), Characteristics and prognosis of patients with primary metastatic disease vs. recurrent HER2-negative, hormone receptor-positive advanced breast cancer. Breast. 2025 Apr;80:104412. doi: 10.1016/j.breast.2025.104412. Epub 2025 Feb 5. PMID: 39952220; PMCID: PMC11872390.
  • Michel L et al. (2025), Prognostic impact of the choice of chemotherapy after first-line CDK4/6 inhibitor therapy in patients with metastatic hormone receptor-positive, HER2-negative breast cancer. Eur J Cancer. 2025 Sep 9;227:115689. doi: 10.1016/j.ejca.2025.115689. Epub 2025 Aug 5. PMID: 40780076.
2024
  • Hartkopf W et al (2024), Attrition in the First Three Therapy Lines in Patients with Advanced Breast Cancer in the German Real World PRAEGNANT Registry. Geburtshilfe Frauenheilkd. 2024 May 29;84(5):459-469. doi: 10.1055/a-2286-5372. PMID: 38817595; PMCID: PMC11136529.
  • Fasching PA et al. (2024), Susceptibility gene mutations in germline and tumors of patients with HER2-negative advanced breast cancer. NPJ Breast Cancer. 2024 Jul 13;10(1):57. doi: 10.1038/s41523-024-00667-x. PMID: 39003306; PMCID: PMC11246424.
  • Huebner H et al. (2024), Cell-free tumor DNA analysis in advanced or metastatic breast cancer patients: mutation frequencies, testing intention, and clinical impact. Precis Clin Med. 2024 Dec 24;8(1):pbae034. doi: 10.1093/pcmedi/pbae034. PMID: 39839709; PMCID: PMC11748133.
  • Ziegler P et al. (2024), The impact of physical activity on progression-free and overall survival in metastatic breast cancer based on molecular subtype. BMC Cancer. 2024 Oct 16;24(1):1284. doi: 10.1186/s12885-024-13038-3. PMID: 39415149; PMCID: PMC11481816.
2023
  • Müller et al. (2023), Systemic Therapy of Premenopausal Patients with Early Stage Hormone Receptor-Positive, HER2-Negative Breast Cancer – Controversies and Standards in Healthcare, Geburtshilfe Frauenheilkd. 2023 May 23;83(6):673-685, PMCID: PMC10442909
  • Huebner et al. (2023), Return of individual genomic research results within the PRAEGNANT multicenter according to patient and tumor characteristics – a retrospective analysis of a real registry study, Breast Cancer Res Treat. 2023 Jan;197(2):355-368, PMCID: PMC9822879
2022
  • Müller et al. (2022), Occurrence and characteristics of patients with de novo advanced breast cancer world registry, Eur J Cancer. 2022 Sep:172:13-21, DOI: 10.1016/j.ejca.2022.05.015
  • Engler et al. (2022), Implementation of CDK4/6 Inhibitors and its Influence ot the Treatment Landscape of Advanced Breast Cancer Patients – Data from the Real-World Registry PRAEGNANT, Geburtshilfe Frauenheilkd. 2022 Jul 12;82(10):1055-1067, PMCID:PMC9525148
2021
  • Hein et al. (2021), Prognostic effect of low-level HER2 expression in patients with clinically negative HER2 status, Eur J Cancer. 2021 Sep:155:1-12, DOI: 10.1016/j.ejca.2021.06.033
  • Fasching PA et al. (2021), Mutations in BRCA1/2 and Other Panel Genes in Patients With Metastatic Breast Cancer – Association With Patient and Disease Characteristics and Effect on Prognosis, J Clin Oncol. 2021 May 20;39(15):1619-1630, PMCID: PMC8274805
2020
  • Schneeweiss A, Ettl J et al. (2020), Initial experience with CDK4/6 inhibitor-based therapies compared to antihormone monotherapies in routine clinical use in patients with hormone receptor positive, HER2 negative breast cancer – Data from the PRAEGNANT research network for the first 2 years of drug availability in Germany, Breast. 2020 Dec:54:88-95, PMCID: PMC7509062
  • Huebner H et al. (2020), Heregulin (HRG) assessment for clinical trial eligibility testing in a molecular registry (PRAEGNANT) in Germany, BMC Cancer. 2020 Nov 11;20(1):1091, PMCID: PMC7656772
  • Laakmann E et al. (2020), Treatment landscape and prognosis after treatment with trastuzumab Emtansine, Geburtshilfe Frauenheilkd. 2020 Nov 6;80(11):1134-1142, doi: 10.1055/a-1286-2917
  • Michel L et al. (2020), Progression-free survival and overall survival in patients with advanced HER2-positive breast cancer treated with Trastuzumab Emtansine (T-DM1) after previous treatment with pertuzumab, Cancers (Basel). 2020 Oct 17;12(10):3021, doi: 10.3390/cancers12103021
2019
  • Fasching PA, Hartkopf AD et al. (2019), Efficacy of neoadjuvant pertuzumab in addition to chemotherapy and trastuzumab in routine clinical treatment of patients with primary breast cancer: a multicentric analysis, Breast Cancer Res Treat. 2019 Jan;173(2):319-328, DOI: 10.1007/s10549-018-5008-3
2018
  • Lux MP, Nabieva N et al. (2018), Therapy Landscape in Patients with Metastatic HER2-Positive Breast Cancer: Data from the PRAEGNANT Real-World Breast Cancer Registry, Cancers (Basel). 2018 Dec 21;11(1):10, doi: 10.3390/cancers11010010
  • Hartkopf AD, Huober J et al. (2018), Treatment landscape of advanced breast cancer patients with hormone receptor positive HER2 negative tumors – Data from the German PRAEGNANT breast cancer registry, Breast. 2018 Feb;37:42-51, DOI: 10.1016/j.breast.2017.10.002
  • Müller V, Wallwiener M et al. (2018), Impact of disease progression on health-related quality of life in patients with metastatic breast cancer in the PRAEGNANT breast cancer registry, Breast. 2018 Feb:37:154-160, DOI: 10.1016/j.breast.2017.08.008
2017
  • Yinchong Yang et al. (2017), Modeling Progression Free Survival in Breast Cancer with Tensorized Recurrent Neural Networks and Accelerated Failure Time Model, Proceedings of the 2nd Machine Learning for Healthcare Conference, PMLR 68:164-176, 2017, https://proceedings.mlr.press/v68/yang17a.html
  • Fremd C et al. (2017), Use of complementary and integrative medicine among German breast cancer patients: predictors and implications for patient care within the PRAEGNANT study network, Arch Gynecol Obstet. 2017 May;295(5):1239-1245, DOI: https://doi.org/10.1007/s00404-017-4348-2
  • Wallwiener et al. (2017), Implementation and Feasibility of Electronic Patient-Reported Outcome (ePRO) Data Entry in the PRAEGNANT Real-Time Advanced and Metastatic Breast Cancer Registry, Geburtshilfe Frauenheilkd. 2017 Aug;77(8):870-878, PMCID: PMC5570586
  • Yinchong Yang et al. (2017), Predictive Modeling of Therapy Decisions in Metastatic Breast Cancer with Recurrent Neural Network Encoder and Multinomial Hierarchical Regression Decoder, IEEE International Conference on Healthcare Informatics (ICHI), Park City, UT, USA, 2017, pp. 46-55, >Download paper
2016
  • Hein A et al. (2016), Computerized patient identification for the EMBRACA clinical trial using real-time data from the PRAEGNANT network for metastatic breast cancer patients, Breast Cancer Res Treat. 2016 Jul;158(1):59-65, DOI: 10.1007/s10549-016-3850-8
  • Yinchong Yang et al. (2016), Predictive Clinical Decision Support System with RNN Encoding and Tensor Decoding, >Download paper
2015
  • Fasching PA et al. (2015), Biomarkers in Patients with Metastatic Breast Cancer and the PRAEGNANT Study Network, Geburtshilfe Frauenheilkd. 2015 Jan;75(1):41-50, >Download paper
  • Yinchong Yang et al. (2015), Modeling Clinical Decisions with Multinomial Hierarchical Classification, Download paper

PRAEGNANT Young projects

Evaluation von Erbrechen und Bewertung und anderer Nebenwirkungen bei Antikörper-Wirkstoff-Konjugaten. Übelkeit, Erbrechen, Brechreiz und die Einnahme von Antiemetika werden vom ersten bis zum 21. Tag nach der T-Dxd- oder SG-Infusion während der ersten drei Therapiezyklen anhand eigens entwickelter Fragenbögen bewertet. EMERGE-ADC ist eine laufende prospektive Teilstudie im PREAGNANT-Netzwerk mit 6 Studienzentren und bereits mehr als 25 eingeschlossenen Patienten.

Studiendesign der EMERGE-ADC-Studie erstellt mit Biorender.org
zum vergrößern bitte klicken

 

Visitenplan der EMERGE-ADC Studie

 

  • prospektive Real-World-Analyse aus dem PRAEGNANT-Register
  • PFS- und OS-Werte vergleichbar zu zulassungsrelevante Studien (SOLAR-1 und BYLieve)
  • explorative Subgruppenanalysen
  • Auswertung ermöglicht ein besseres Verständnis von Alpelisib und seinen potenziellen Auswirkungen auf Subgruppen in der real-world
 
Manuscript prepared – To be published zum vergrößern bitte klicken

Assessment of vomiting and evaluation of other side effects associated with antibody-drug conjugates. Nausea, vomiting, the urge to vomit, and the use of antiemetics are assessed from Day 1 through Day 21 following the T-Dxd or SG infusion during the first three treatment cycles using specifically developed questionnaires. EMERGE-ADC is an ongoing prospective substudy within the PRAEGNANT network, involving 6 study centers and already more than 25 enrolled patients.

Study design of EMERGE-ADC-Study
created with Biorender.org
Please click to enlarge

 

Visit schedule for EMERGE-ADC Study

PRAEGNANT Young publications

  • Hörner M et al. (2026), Alpelisib and Fulvestrant in PIK3CA-mutated hormone receptor-positive HER2-negative advanced breast cancer included in the German PRAEGNANT trial. Breast Cancer Res Treat. 2026 Apr 2;217(1):9. doi: 10.1007_s10549-026-07939-z PMID: 41925922; PMCID: PMC13046609.
  • Hörner M et al. (2026), PARP inhibition with olaparib and talazoparib for HER2-negative advanced breast cancer-Results from the prospective PRAEGNANT registry. NPJ Breast Cancer. 2026 Apr 11;12(1):60. doi: 10.1038/s41523-026-00947-8. PMID: 41965791; PMCID: PMC13087296.
Please click on the year to see the publications
2026
  • Hörner M et al. (2026), Alpelisib and Fulvestrant in PIK3CA-mutated hormone receptor-positive HER2-negative advanced breast cancer included in the German PRAEGNANT trial. Breast Cancer Res Treat. 2026 Apr 2;217(1):9. doi: 10.1007_s10549-026-07939-z PMID: 41925922; PMCID: PMC13046609.
  • Hörner M et al. (2026), PARP inhibition with olaparib and talazoparib for HER2-negative advanced breast cancer-Results from the prospective PRAEGNANT registry. NPJ Breast Cancer. 2026 Apr 11;12(1):60. doi: 10.1038/s41523-026-00947-8. PMID: 41965791; PMCID: PMC13087296.
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