Advanced/Metastatic Breast Cancer, Breast Cancer (Early Breast Cancer)
Conditions
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.
Interventions
PROCEDUREBlood sampling
A blood sample will be taken during a routine blood draw
Sponsors
University Hospital Tuebingen
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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: 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: 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: 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: 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: 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: Incidence of adverse events, serious adverse events will be reported. | up to 60 months | According to NCI Common Toxicity Criteria Version 4.03. |
| 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. |
| 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. |
| 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: 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: 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: 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: 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: 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 |
| 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. |
| 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. |
| 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: Incidence of adverse events, serious ad-verse events will be reported. | up to 60 months | NCI Common Toxicity Criteria Version 4.03. |
| 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. |
Countries
Germany
Contacts
CONTACTErik Belleville, PhD
PRINCIPAL_INVESTIGATORDiethelm Wallwiener, Prof. Dr.
Universitätsfrauenklinik Tübingen
PRINCIPAL_INVESTIGATORPeter Fasching, Prof. Dr.
Frauenklinik des Universitätsklinikums Erlangen
PRINCIPAL_INVESTIGATORSara Brucker, Prof. Dr.
Universitätsfrauenklinik Tübingen
PRINCIPAL_INVESTIGATORHans Tesch, Prof. Dr.
Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus Frankfurt
PRINCIPAL_INVESTIGATORAndreas Schneeweiss, Prof. Dr.
Nationales Centrum für Tumorerkrankungen (NCT) Sektion Gynäkologische Onkologie Heidelberg
Outcome results
None listed