Observational study on breast cancer patients with early and advanced stages

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on patients with early and advanced metastatic breast cancer, aiming to improve therapy decisions through molecular assessment of tumor characteristics. It highlights the challenges faced by metastatic patients, who often have the worst prognosis and may not receive optimal treatment due to reliance on primary tumor characteristics. The study involves blood sampling to gather data on tumor biology and patient outcomes, with the goal of enhancing personalized treatment approaches. By evaluating the effectiveness of targeted therapies, the study seeks to address the gap in routine molecular assessments for metastatic breast cancer patients.

Why it matters

Who can join: the full rules

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

Where it's running

• Klinikum Sindelfingen-Böblingen gGmbH
  Böblingen, Baden-Wurttemberg, Germany Recruiting
• Klinik für Frauenheilkunde, Universitätsklinikum Freiburg
  Freiburg im Breisgau, Baden-Wurttemberg, Germany Recruiting
• NCT Heidelberg
  Heidelberg, Baden-Wurttemberg, Germany Recruiting
• ViDia Christliche Kliniken Karlsruhe
  Karlsruhe, Baden-Wurttemberg, Germany Recruiting
• Praxisklinik am Rosengarten
  Mannheim, Baden-Wurttemberg, Germany Recruiting
• medius Klinik Nürtingen
  Nürtingen, Baden-Wurttemberg, Germany Recruiting

+11 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Diethelm Wallwiener, Prof. Dr. — Universitätsfrauenklinik Tübingen
• Study coordinator: Erik Belleville, PhD
• Email: belleville@clin-sol.com
• Phone: +49 931 359200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.