Advanced/Metastatic Breast Cancer Clinical Trial
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
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00662025 -
Study Of Sunitinib With Capecitabine In Breast Cancer
|
Phase 2 |