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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 13,500
- 试验地点
- 105
- 主要终点
- MBC (Metastatic Breast Cancer): Discovery of biomarkers, which predict progression free survival (PFS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Advanced/metastatic breast cancer
3,500 patients with locally advanced, inoperable/metastatic breast cancer in any line of treatment (e.g. 1st, 2nd, 3rd, or ≥ 4th line).
干预措施: Blood sampling (Procedure)
Early breast cancer
10,000 patients with breast cancer in the neoadjuvant and adjuvant (early breast cancer) setting independent of treatment regimen.
干预措施: Blood sampling (Procedure)
结局指标
主要结局
MBC (Metastatic Breast Cancer): Discovery of biomarkers, which predict progression free survival (PFS)
时间窗: 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)
时间窗: 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
次要结局
- EBC: Therapy adherence(up to 60 months)
- MBC: Assessment of breast cancer specific survival (BCSS)(Time to death 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)
- 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)
- MBC: Description of therapies used in the metastatic setting(after 60 months (after study completion))
- MBC: Therapy adherence(up to 60 months)
- MBC: Incidence of adverse events, serious adverse events will be reported.(up to 60 months)
- 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.)
- 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.)
- EBC: Description of therapies used in the early breast cancer setting(after 60 months (after study completion))
- 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.)
- MBC: Feasibility and satisfaction regarding receipt of molecular testing results (including hereditary genetic alterations)(Once at end of study)
- EBC: Assessment of distant disease-free survival (DDFS)(Up to 60 months)
- 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)
- 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)
- EBC: Feasibility and satisfaction regarding receipt of molecular testing results (including hereditary genetic alterations)(Once at end of study)
- EBC: Incidence of adverse events, serious ad-verse events will be reported.(up to 60 months)
- MBC: Objective response(up to 60 months)
- 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)
- 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)
- EBC: Health economics for women with breast cancer(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.(Once at end of study)
- 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)
- 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)