Praegnant Breast Cancer: Early/Advanced/Metastatic

Official title

Prospective Academic Translational Research Network for the Optimization of the Oncological Health Care Quality in the Adjuvant and Advanced/Metastatic Setting: Health Care Research, Pharmacogenomics, Biomarkers, Health Economics

Overview

Among patients with breast cancer the subgroup of patients with metastases are considered the group of patients with the worst prognosis. Not only regard-ing therapy decisions but also with regard to quality assured healthcare and health economics this entity of patients remains a challenge. Recently, novel advances in breast cancer therapy aim at the targeted therapy of tumor entities and identification of patients, for whom the greatest therapy benefit, and the least side effects are expected. However molecular assessment of the patient and the tumor in the metastatic situation is not performed on a routine basis and in many cases tumor character-istics from the primary tumor are considered reliable enough to make therapy decisions for the metastatic patients. Although molecular reassessment of tu-mor characteristics from tumor material of the metastasis is recommended in national guidelines, only a minority of patients is biopsied, because of the inva-siveness of the procedure, even though biopsy related complications are reported to be rare. With modern analytic methods from blood based biomaterial there seems to be an opportunity to correlate blood based tumor assessments with actual charac-teristics of the tumor. These include expression analysis, tumor mutation analy-sis, tumor gene copy number aberrations and others. One of the main aims of the PRAEGNANT study is therefore to establish an infrastructure for the compre-hensive analysis of tumor and metastatic molecular characteristics of the patient and the tumor. Furthermore, health care related outcomes as well as health economics provide novel approaches for integration of patients in study conduct and health care awareness and are study aims of the PRAEGNANT study.

Interventions

• Procedure Blood sampling
  A blood sample will be taken during a routine blood draw

Primary outcome measures

• MBC (Metastatic Breast Cancer): Discovery of biomarkers, which predict progression free survival (PFS) [Time frame: PFS defined as the time to the first progression after study inclusion from the last time of progression before or at study entry]
• EBC (Early Breast Cancer): Assessment of disease free sur-vival (DFS) [Time frame: up to 60 months]

Secondary outcome measures (12)

• MBC: Assessment of overall survival (OS) [Time frame: OS is defined as the time to death from the date of the last progression before or at study entry.]
• MBC: Assessment of breast cancer specific survival (BCSS) [Time frame: Time to death from the date of the last progression before or at study entry.]
• MBC: Objective response [Time frame: up to 60 months]
• MBC: Description of therapies used in the metastatic setting [Time frame: after 60 months (after study completion)]
• MBC: Quality of life [Time frame: Study entry and every 3 month or following a change of a therapy line(event-associated, e.g. after progression) until Month 24. Every 6 months from Month 24 until Death or withdrawal of consent]
• MBC: Therapy adherence [Time frame: up to 60 months]
• MBC: Influencing Factors of Depression in patients with metastatic breast cancer [Time frame: Study entry and every 3 month or following a change of a therapy line (event-associated, e.g. after progression) until Month 24. Every 6 months from Month 24 until Death or withdrawal of consent]
• MBC: Incidence of adverse events, serious adverse events will be reported. [Time frame: up to 60 months]
• MBC: Percentage of women, who will receive results of molecular tests undertaken in the context of the scientific objectives of this trial. [Time frame: Once at end of study]
• MBC: Feasibility and satisfaction regarding receipt of molecular testing results (including hereditary genetic alterations) [Time frame: Once at end of study]
• MBC: Health economics for women with metastatic and/or locally advanced, inoperable breast cancer. [Time frame: Study entry and every 3 month or following a change of a therapy line (event-associated, e.g. after progression) until Month 24. Every 6 months from Month 24 until Death or withdrawal of consent]
• MBC: Patient reported influencing factors on therapy adherence in patients metastatic and/or locally advanced, inoperable breast cancer. [Time frame: Study entry and every 3 month or following a change of a therapy line(event-associated, e.g. after progression) until Month 24. Every 6 months from Month 24 until Death or withdrawal of consent]

Eligibility criteria

Inclusion Criteria for the early breast cancer setting:

• Adult breast cancer patients (age ≥18 years)
• Patients with breast cancer and no evidence of distant metastases with a diagnosis not longer than 91 days before study entry
• Patients, who are able and willing to sign the informed consent form

Inclusion Criteria for the advanced/metastatic setting:

• Adult women aged ≥18 years
• Patients with the diagnosis of invasive breast cancer (in German: Mammakarzinom, as op-posed to "non-invasive"= ductales Carcinoma in situ; irrespective of status of BC, e.g. TNM, re-ceptor status etc.) and
• Patients, who are willing and able to sign the informed consent form
• Patients with metastatic or locally advanced, inoperable disease proven by clinical measures (i.e. standard imaging)

Exclusion criteria

• Patients who did not sign the informed consent form
• Patients, who are not eligible for observation due to non-availability and/or severe comor-bidities as evaluated by the treating physician

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

Germany · 61 centers

• Klinikum Sindelfingen-Böblingen gGmbH — Böblingen
• Klinik für Frauenheilkunde, Universitätsklinikum Freiburg — Freiburg im Breisgau
• NCT Heidelberg — Heidelberg
• ViDia Christliche Kliniken Karlsruhe — Karlsruhe
• Praxisklinik am Rosengarten — Mannheim
• medius Klinik Nürtingen — Nürtingen
• Universitätsfrauenklinik Tübingen — Tübingen
• Universitätsfrauenklinik Ulm — Ulm
• … and 53 more centers

Publications

• Horner M, Tretschock LM, John N, Ziegler P, Haberle L, Uhrig S, Goossens C, Amann N, Cieslik JP, Dannehl D, Deutsch TM, Dimpfl M, Ehlert M, Eichstadt K, Englisch A, Kopke MB, Kruckel A, Link T, Muller A, Reinhardt K, Roth J, Schaffler H, Sych L, Tegeler CM, Wichmann C, Banys-Paluchowski M, Princk H, Rody A, Brucker SY, Ditsch N, Ettl J, Fehm T, Hack CC, Hadji P, Hein A, Janni WW, Kolberg HC, Luftn PMID 41925922
• Muller V, Hein A, Hartkopf AD, Fasching PA, Kolberg HC, Hadji P, Tesch H, Haberle L, Ettl J, Luftner D, Wallwiener M, Beckmann MW, Schneeweiss A, Belleville E, Uhrig S, Wimberger P, Hielscher C, Meyer J, Wurmthaler LA, Kurbacher CM, Wuerstlein R, Untch M, Janni W, Taran FA, Lux MP, Wallwiener D, Brucker SY, Fehm TN, Michel LL. Occurrence and characteristics of patients with de novo advanced breast PMID 35728342
• Hein A, Hartkopf AD, Emons J, Lux MP, Volz B, Taran FA, Overkamp F, Hadji P, Tesch H, Haberle L, Ettl J, Luftner D, Wurmthaler LA, Wallwiener M, Muller V, Beckmann MW, Belleville E, Wimberger P, Hielscher C, Kurbacher CM, Wuerstlein R, Thomssen C, Untch M, Fasching PA, Janni W, Fehm TN, Wallwiener D, Brucker SY, Schneeweiss A, Kolberg HC. Prognostic effect of low-level HER2 expression in patients PMID 34311211
• Huebner H, Kurbacher CM, Kuesters G, Hartkopf AD, Lux MP, Huober J, Volz B, Taran FA, Overkamp F, Tesch H, Haberle L, Luftner D, Wallwiener M, Muller V, Beckmann MW, Belleville E, Ruebner M, Untch M, Fasching PA, Janni W, Fehm TN, Kolberg HC, Wallwiener D, Brucker SY, Schneeweiss A, Ettl J. Heregulin (HRG) assessment for clinical trial eligibility testing in a molecular registry (PRAEGNANT) in Ger PMID 33176725

Identifiers

NCT: NCT02338167 · SEN-01/14

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗