Praegnant Breast Cancer: Early/Advanced/Metastatic (PRAEGNANT)

University Hospital Tuebingen

Status

Enrolling

Conditions

Advanced/Metastatic Breast Cancer

Breast Cancer (Early Breast Cancer)

Treatments

Procedure: Blood sampling

Study type

Observational

Funder types

Other

Identifiers

NCT02338167

SEN-01/14

Details and patient eligibility

About

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.

Enrollment

13,500 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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