Breast Cancer Registry Platform (OPAL)
June 3, 2026 updated by: iOMEDICO AG
Treatment and Outcome of Patients With Breast Cancer: Clinical Research Platform for Real World Data
The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study with associated satellites, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with breast cancer in Germany.
Study Overview
Status
Recruiting
Conditions
Detailed Description
OPAL is a national, observational, prospective, longitudinal, multicenter cohort study (tumor registry platform) with the purpose to record information on the antineoplastic treatment of breast cancer in Germany. The registry will follow patients for up to five years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented.
Health-related quality of life in patients with breast cancer will be evaluated for up to five years.
Study Type
Observational
Enrollment (Estimated)
6150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lisa Kruggel
- Phone Number: +49 761 15242-0
- Email: info@iomedico.com
Study Contact Backup
- Name: Ursula Dietrich
- Phone Number: +49 761 15242-0
- Email: info@iomedico.com
Study Locations
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Many Locations, Germany
- Recruiting
- Multiple sites all over germany
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Contact:
- iOMEDICO AG
- Phone Number: +49 761 15242-0
- Email: info@iomedico.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adult female and male patients with breast cancer starting first systemic treatment for EBC or ABC.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Advanced breast cancer - Her2 positive
Patients with HER2-positive advanced breast cancer
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Advanced breast cancer - triple negative
Patients with triple negative advanced breast cancer
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Advanced breast cancer - HR positive, Her2 negative
Patients with HR positive, Her2 negative advanced breast cancer
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Early breast cancer - HER2 positive
Patients with HER2 positive early breast cancer
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Early breast cancer - triple negative
Patients with triple negative early breast cancer
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Early breast cancer - HR positive, HER2 negative
Patients with HR positive, HER2 negative early breast cancer
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Treatment reality
Time Frame: 5 years
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Description of treatment reality (Course of systemic treatments and sequential treatments) applied in German routine practice measured as the frequency of the various systemic treatments applied per line of therapy.
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5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Best Response
Time Frame: 5 years
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Documentation of response rates per line of treatment.
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5 years
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Progression-free survival
Time Frame: 5 years
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Documentation of progression-free survival per line of treatment.
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5 years
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Overall survival
Time Frame: 5 years
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Documentation of date of death.
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5 years
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Health-related quality of life (Patient-reported outcome)
Time Frame: 3.5 years
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EORTC QLQ-C30 core questionnaire and additional items.
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3.5 years
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Disease-free survival
Time Frame: 5 years
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Documentation of disease-free survival.
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5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Norbert Marschner, MD, Praxis für interdisziplinäre Onkologie & Hämatologie
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Marschner P, Ringwald K, Thill M, Zahn MO, Welt A, Nusch A, Kaltenecker G, Rodemer Y, Hagen V, Schock C, Kruggel L, Kaiser-Osterhues A, Klein D, Haug N, Stickeler E, Harbeck N, Wockel A, Marschner N, Decker T; OPAL Registry Group. Prediction of dose reductions and impact of reduced starting doses of CDK4/6i on effectiveness in HR-positive/HER2-negative metastatic breast cancer: Real-world data from the OPAL registry. Int J Cancer. 2026 Jul 1;159(1):244-256. doi: 10.1002/ijc.70433. Epub 2026 Mar 18.
- Thill M, Zahn MO, Welt A, Nusch A, Zaiss M, Engelken K, Kaltenecker G, Ringwald K, Gratzke K, Dille S, Kruggel L, Janicke M, Schulz H, Hagen V, Fricker R, Stickeler E, Harbeck N, Wockel A, Decker T. Head-to-head comparison of palbociclib and ribociclib in first-line treatment of HR-positive/HER2-negative metastatic breast cancer with real-world data from the OPAL registry. Int J Cancer. 2025 May 1;156(9):1770-1782. doi: 10.1002/ijc.35296. Epub 2024 Dec 20.
- Thill M, Zahn MO, Welt A, Stickeler E, Nusch A, Fietz T, Rauh J, Wetzel N, Kruggel L, Janicke M, Marschner N, Harbeck N, Wockel A, Decker T; OPAL study group. Treatment and outcome in metastatic lobular breast cancer in the prospective German research platform OPAL. Breast Cancer Res Treat. 2023 Apr;198(3):545-553. doi: 10.1007/s10549-023-06882-7. Epub 2023 Feb 18.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 22, 2017
Primary Completion (Estimated)
June 1, 2032
Study Completion (Estimated)
June 1, 2032
Study Registration Dates
First Submitted
January 24, 2018
First Submitted That Met QC Criteria
January 30, 2018
First Posted (Actual)
January 31, 2018
Study Record Updates
Last Update Posted (Actual)
June 5, 2026
Last Update Submitted That Met QC Criteria
June 3, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IOM-100361
- Registerplattform OPAL (Other Identifier: iOMEDICO)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
product manufactured in and exported from the U.S.
No
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