Praegnant Breast Cancer: Early/Advanced/Metastatic
- Conditions
- Breast Cancer (Early Breast Cancer)Advanced/Metastatic Breast Cancer
- Registration Number
- NCT02338167
- Lead Sponsor
- University Hospital Tuebingen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 13500
Not provided
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MBC (Metastatic Breast Cancer): Discovery of biomarkers, which predict progression free survival (PFS) PFS defined as the time to the first progression after study inclusion from the last time of progression before or at study entry 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.
EBC (Early Breast Cancer): Assessment of disease free sur-vival (DFS) up to 60 months DFS defined as the time to the first disease recurrence after study inclusion from time of primary diagnosis before or at study entry
- Secondary Outcome Measures
Name Time Method MBC: Assessment of breast cancer specific survival (BCSS) Time to death from the date of the last progression before or at study entry. 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.
MBC: Quality of life 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 Assessed with EORTC QlQ-C30 and Visual Analog Scala
MBC: Health economics for women with metastatic and/or locally advanced, inoperable breast cancer. 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 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.
MBC: Description of therapies used in the metastatic setting after 60 months (after study completion) Therapies will be categorized and descriptive statistics will be presented.
MBC: Therapy adherence up to 60 months Defined as the percentage of patients in which treat-ments which are terminated as per patients' wish or because of treatment related side effect.
MBC: Incidence of adverse events, serious adverse events will be reported. up to 60 months According to NCI Common Toxicity Criteria Version 4.03.
EBC: 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. OS is defined as the time to death from the date of the primary diagnosis before or at study entry.
EBC: Assessment of breast cancer specific survival (BCSS) Time to death due to breast cancer from the date of the primary diagnosis before or at study entry. BCSS is defined as the 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 after 60 months (after study completion) Therapies will be categorized, and descriptive statistics will be presented.
EBC: Therapy adherence up to 60 months Defined as the percentage of patients in which treat-ments which are terminated as per patients' wish or because of treatment related side effect
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. OS is defined as the time to death from the date of the last progression before or at study entry.
MBC: Feasibility and satisfaction regarding receipt of molecular testing results (including hereditary genetic alterations) Once at end of study Assessed with a physician and patient questionnaire and documentation of possible confirmatory testing for changes in therapy or eligibility for interventional clinical trial screening.
EBC: Assessment of distant disease-free survival (DDFS) Up to 60 months DDFS defined as the time to the first distant disease recurrence after study inclusion from time of primary diagnosis before or at study entry.
EBC: Quality of life 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 Assessed with EORTC QLQ C-30 (Version 3.0), EORTC QLQ-BR23 and the EQ-Visual Analog Scale (VAS)
EBC: Percentage of women, who will receive results of molecular tests undertaken in the context of the scientific objectives of this trial. Once at end of study Number of patients who will receive molecular testing results compared to the total number of included pa-tients.
EBC: Feasibility and satisfaction regarding receipt of molecular testing results (including hereditary genetic alterations) Once at end of study Assessed with a physician and patient questionnaire and documentation of possible confirmatory testing for changes in therapy or eligibility for interventional clinical trial screening.
EBC: Incidence of adverse events, serious ad-verse events will be reported. up to 60 months NCI Common Toxicity Criteria Version 4.03.
MBC: Objective response up to 60 months Objective response is defined as the best-documented response to the therapy started at study entry or the last therapy started before study entry.
MBC: Influencing Factors of Depression in patients with metastatic breast cancer 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 Depression will be assessed by patient reported questionnaires e.g. CESD-R.
MBC: Patient reported influencing factors on therapy adherence in patients metastatic and/or locally advanced, inoperable breast cancer. 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 Patient reported adherence for orally administered therapies will be assessed with suitable questionnaires.
EBC: Health economics for women with breast cancer up to 60 months 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.
MBC: Percentage of women, who will receive results of molecular tests undertaken in the context of the scientific objectives of this trial. Once at end of study Number of patients who will receive molecular testing results compared to the total number of included patients.
EBC: Influencing Factors of Depression in patients with breast cancer 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 Depression will be assessed by patient reported ques-tionnaires e.g. CESD-R.
EBC: Patient reported influencing factors on therapy adherence in patients with early breast cancer. 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 Patient reported adherence for orally administered therapies will be assessed with suitable questionnaires.
Trial Locations
- Locations (58)
Klinikum Sindelfingen-Böblingen gGmbH
🇩🇪Böblingen, Baden-Württemberg, Germany
Klinik für Frauenheilkunde, Universitätsklinikum Freiburg
🇩🇪Freiburg, Baden-Württemberg, Germany
NCT Heidelberg
🇩🇪Heidelberg, Baden-Württemberg, Germany
Frauenklinik der St. Vincentius-Kliniken gAG
🇩🇪Karlsruhe, Baden-Württemberg, Germany
Praxisklinik am Rosengarten
🇩🇪Mannheim, Baden-Württemberg, Germany
medius Klinik Nürtingen
🇩🇪Nürtingen, Baden-Württemberg, Germany
Paracelsus Krankenhaus Ruit
🇩🇪Ruit, Baden-Württemberg, Germany
Universitätsfrauenklinik Tübingen
🇩🇪Tübingen, Baden-Württemberg, Germany
Universitätsfrauenklinik Ulm
🇩🇪Ulm, Baden-Württemberg, Germany
St. Vincentius-Kliniken gAG
🇩🇪Karlsruhe, Baden-Württenmberg, Germany
Scroll for more (48 remaining)Klinikum Sindelfingen-Böblingen gGmbH🇩🇪Böblingen, Baden-Württemberg, Germany