Home › Trials › NCT02338167

Observational study on breast cancer patients with early and advanced stages

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

Observational University Hospital Tuebingen · NCT02338167

This study is trying to see if testing the biology of tumors in breast cancer patients can help doctors make better treatment choices for those with early and advanced stages of the disease.

Quick facts

Study typeObservational
Enrollment13500 (estimated)
Ages18 Years to 99 Years
SexAll
SponsorUniversity Hospital Tuebingen Academic / other
Locations61 sites (Böblingen, Baden-Wurttemberg and 60 other locations)
Trial IDNCT02338167 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adult women aged 18 and older with either early breast cancer diagnosed within the last 91 days or those with advanced or metastatic breast cancer.

Not a fit: Patients who are not eligible for observation due to severe comorbidities or who do not sign the informed consent form may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for breast cancer patients, particularly those with advanced disease.

How similar studies have performed: Other studies have shown success in utilizing molecular assessments for breast cancer treatment, indicating a promising approach in this area.

Eligibility criteria

Show full inclusion / 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

Where this trial is running

Böblingen, Baden-Wurttemberg and 60 other locations

+11 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced/Metastatic Breast CancerBreast Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.