Praegnant Breast Cancer: Early/Advanced/Metastatic
Praegnant Breast Cancer: Early/Advanced/Metastatic
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.
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