Germany Breast Cancer Registry Platform

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

OPAL is a national, observational, prospective, longitudinal study with multiple centers in Germany. It aims to document characteristics, treatments, and disease course, while collecting patient-reported outcomes and building a decentralized biobank. Participants are followed for up to five years, with data on systemic therapies, radiotherapy, surgery, and outcomes captured across cohorts. The study includes early breast cancer patients starting initial systemic treatment, as well as advanced breast cancer patients starting first-line therapy, and retrospective data from a subset of advanced cases. The project seeks to identify common treatment sequences and changes over time.

Why it matters

Who can join: the full rules

EBC cohort:

* Female and male patients with early breast cancer (stage I-III defined as breast cancer that has not spread beyond the breast or the axillary lymph nodes)
* Patients at the start of their initial systemic treatment for EBC, i.e. at start of neoadjuvant treatment for patients receiving neoadjuvant therapy or at start of adjuvant treatment if no neoadjuvant therapy is given. Treatment can be cytotoxic, endocrine, or targeted substances, whatever was given first

ABC cohort I (prospective):

* Female and male patients with advanced breast cancer (stage IV defined as synchrone or metachrone diagnosis of distant metastases at inclusion)
* Patients at the start of their initial first-line systemic treatment for ABC, which can be cytotoxic, endocrine or targeting a specific signaling pathway, whatever is given first

ABC cohort II (retrospective):

* Confirmed diagnosis of HR-positive, HER2-negative ABC (stage IV defined as synchrone or metachrone diagnosis of distant metastases at inclusion)
* Start of initial first-line systemic treatment for ABC, which can be cytotoxic, endocrine or targeting a specific signaling pathway, whatever is given first, between September 2021 and December 2025
* Inclusion is possible regardless of whether patients are alive or deceased at the time of documentation; for patients alive: written informed consent

Prospective cohorts:

* Written informed consent
* Patients participating in the PRO module: signing of informed consent form and completion of baseline questionnaire before start of initial systemic treatment for EBC or systemic first-line treatment for ABC
* All patients not participating in the PRO module: within six weeks after start of initial systemic treatment for EBC or systemic first-line treatment for ABC

All cohorts:

• Age ≥ 18 years

Where it's running

• Multiple sites all over germany
  Many Locations, Germany Recruiting

Study contacts

• Study coordinator: Lisa Kruggel
• Email: info@iomedico.com
• Phone: +49 761 15242-0

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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.