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.
Study Type
OBSERVATIONAL
Enrollment
13,500
A blood sample will be taken during a routine blood draw
Klinikum Sindelfingen-Böblingen gGmbH
Böblingen, Baden-Wurttemberg, Germany
RECRUITINGKlinik für Frauenheilkunde, Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
RECRUITINGNCT Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
RECRUITINGViDia Christliche Kliniken Karlsruhe
Karlsruhe, Baden-Wurttemberg, Germany
MBC (Metastatic Breast Cancer): Discovery of biomarkers, which predict progression free survival (PFS)
Analyses will be done separately for each therapy line. Biomarkers include gene expression profiling of the primary tumor and the corresponding metastases, somatic mutations, germline genetic variation, epigenetic changes and miRNA variation up to a total of 500,000 biomarkers.
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)
DFS defined as the time to the first disease recurrence after study inclusion from time of primary diagnosis before or at study entry
Time frame: up to 60 months
MBC: Assessment of overall survival (OS)
OS is defined as the time to death from the date of the last progression before or at study entry.
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)
BCSS is defined as the time to to death due to breast cancer from the date of the last progression before or at study entry.
Time frame: Time to death from the date of the last progression before or at study entry.
MBC: Objective response
Objective response is defined as the best-documented response to the therapy started at study entry or the last therapy started before study entry.
Time frame: up to 60 months
MBC: Description of therapies used in the metastatic setting
Therapies will be categorized and descriptive statistics will be presented.
Time frame: after 60 months (after study completion)
MBC: Quality of life
Assessed with EORTC QlQ-C30 and Visual Analog Scala
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
Defined as the percentage of patients in which treat-ments which are terminated as per patients' wish or because of treatment related side effect.
Time frame: up to 60 months
MBC: Influencing Factors of Depression in patients with metastatic breast cancer
Depression will be assessed by patient reported questionnaires e.g. CESD-R.
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.
According to NCI Common Toxicity Criteria Version 4.03.
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.
Number of patients who will receive molecular testing results compared to the total number of included patients.
Time frame: Once at end of study
MBC: Feasibility and satisfaction regarding receipt of molecular testing results (including hereditary genetic alterations)
Assessed with a physician and patient questionnaire and documentation of possible confirmatory testing for changes in therapy or eligibility for interventional clinical trial screening.
Time frame: Once at end of study
MBC: Health economics for women with metastatic and/or locally advanced, inoperable breast cancer.
EORTC QLQ C-30 (Version 3.0) (among others) and actu-al documented costs of diagnostic procedures, therapies, treatment of side effects and care for tumor-associated symptoms will be used to calculate health care costs, quality adjusted life years (QALY) and incremental cost effectiveness ratios (ICER) between patient groups.
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.
Patient reported adherence for orally administered therapies will be assessed with suitable questionnaires.
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
EBC: Assessment of distant disease-free survival (DDFS)
DDFS defined as the time to the first distant disease recurrence after study inclusion from time of primary diagnosis before or at study entry.
Time frame: Up to 60 months
EBC: Quality of life
Assessed with EORTC QLQ C-30 (Version 3.0), EORTC QLQ-BR23 and the EQ-Visual Analog Scale (VAS)
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
EBC: Assessment of overall survival (OS)
OS is defined as the time to death from the date of the primary diagnosis before or at study entry.
Time frame: OS is defined as the time to death from the date of the last progression before or at study entry.
EBC: Assessment of breast cancer specific survival (BCSS)
BCSS is defined as the time to death due to breast cancer from the date of the primary diagnosis before or at study entry.
Time frame: Time to death due to breast cancer from the date of the primary diagnosis before or at study entry.
EBC: Description of therapies used in the early breast cancer setting
Therapies will be categorized, and descriptive statistics will be presented.
Time frame: after 60 months (after study completion)
EBC: Percentage of women, who will receive results of molecular tests undertaken in the context of the scientific objectives of this trial.
Number of patients who will receive molecular testing results compared to the total number of included pa-tients.
Time frame: Once at end of study
EBC: Feasibility and satisfaction regarding receipt of molecular testing results (including hereditary genetic alterations)
Assessed with a physician and patient questionnaire and documentation of possible confirmatory testing for changes in therapy or eligibility for interventional clinical trial screening.
Time frame: Once at end of study
EBC: Therapy adherence
Defined as the percentage of patients in which treat-ments which are terminated as per patients' wish or because of treatment related side effect
Time frame: up to 60 months
EBC: Health economics for women with breast cancer
EORTC QLQ C-30 (Version 3.0) (among others) and actu-al documented costs of diagnostic procedures, thera-pies, treatment of side effects and care for tumor-associated symptoms will be used to calculate health care costs, quality adjusted life years (QALY) and incre-mental cost effectiveness ratios (ICER) between patient groups.
Time frame: up to 60 months
EBC: Influencing Factors of Depression in patients with breast cancer
Depression will be assessed by patient reported ques-tionnaires e.g. CESD-R.
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
EBC: Patient reported influencing factors on therapy adherence in patients with early breast cancer.
Patient reported adherence for orally administered therapies will be assessed with suitable questionnaires.
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
EBC: Incidence of adverse events, serious ad-verse events will be reported.
NCI Common Toxicity Criteria Version 4.03.
Time frame: up to 60 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Praxisklinik am Rosengarten
Mannheim, Baden-Wurttemberg, Germany
RECRUITINGmedius Klinik Nürtingen
Nürtingen, Baden-Wurttemberg, Germany
RECRUITINGUniversitätsfrauenklinik Tübingen
Tübingen, Baden-Wurttemberg, Germany
RECRUITINGUniversitätsfrauenklinik Ulm
Ulm, Baden-Wurttemberg, Germany
RECRUITINGGesundheitszentrum St. Marien GmbH
Amberg, Bavaria, Germany
RECRUITINGAnregiomed gKK Klinikum Ansbach Brustzentrum Westmittelfranken
Ansbach, Bavaria, Germany
RECRUITING...and 51 more locations