Breast CancerOPALNCT03417115
Breast Cancer Registry Platform
An observational study of Breast Cancer, run by iOMEDICO AG at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 6,150 participants
- Where
- 1 siteGermany
- Study dates
- 22 Dec 2017to Jun 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult female and male patients with breast cancer starting first systemic treatment for EBC or ABC.
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Multiple sites all over germany
Many Locations
iOMEDICO AG, +49 761 15242-0, info@iomedico.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Epidemiology, Registry, Health Services Research, Germany, Palliative Treatment, Adjuvant Treatment, Neoadjuvant Treatment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Advanced breast cancer - Her2 positive | Patients with HER2-positive advanced breast cancer | |
| Advanced breast cancer - triple negative | Patients with triple negative advanced breast cancer | |
| Advanced breast cancer - HR positive, Her2 negative | Patients with HR positive, Her2 negative advanced breast cancer | |
| Early breast cancer - HER2 positive | Patients with HER2 positive early breast cancer | |
| Early breast cancer - triple negative | Patients with triple negative early breast cancer | |
| Early breast cancer - HR positive, HER2 negative | Patients with HR positive, HER2 negative early breast cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment reality
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.
Measured: 5 years
Secondary outcomes (5)
Best Response
Documentation of response rates per line of treatment.
Measured: 5 years
Progression-free survival
Documentation of progression-free survival per line of treatment.
Measured: 5 years
Overall survival
Documentation of date of death.
Measured: 5 years
Health-related quality of life (Patient-reported outcome)
EORTC QLQ-C30 core questionnaire and additional items.
Measured: 3.5 years
Disease-free survival
Documentation of disease-free survival.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start22 Dec 2017
- Primary completionJun 2032 (estimated)
- Study completionJun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,150 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Norbert Marschner, MD, Study chair, Praxis für interdisziplinäre Onkologie & Hämatologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417115
- Sponsor's protocol ID
- IOM-100361
- Other IDs
- Registerplattform OPAL
- Acronym
- OPAL
- Status last verified
- Apr 2026
- First submitted
- 24 Jan 2018
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 41851017Thill 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.
PubMed 39707595Thill 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.
PubMed 36807725
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment and Outcome of Patients With Breast Cancer: Clinical Research Platform for Real World Data
- ClinicalTrials.gov ID
- NCT03417115
- Acronym / sponsor ID
- OPAL / IOM-100361
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Epidemiology, Registry, Health Services Research, Germany, Palliative Treatment, Adjuvant Treatment, Neoadjuvant Treatment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,150 participants (estimated)
- Lead sponsor
- iOMEDICO AGIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2017 (actual)
- Primary completion
- Jun 2032 (estimated)
- Study completion
- Jun 2032 (estimated)
- First posted
- 31 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Advanced breast cancer - Her2 positive | – | –Patients with HER2-positive advanced breast cancer |
| Advanced breast cancer - triple negative | – | –Patients with triple negative advanced breast cancer |
| Advanced breast cancer - HR positive, Her2 negative | – | –Patients with HR positive, Her2 negative advanced breast cancer |
| Early breast cancer - HER2 positive | – | –Patients with HER2 positive early breast cancer |
| Early breast cancer - triple negative | – | –Patients with triple negative early breast cancer |
| Early breast cancer - HR positive, HER2 negative | – | –Patients with HR positive, HER2 negative early breast cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult female and male patients with breast cancer starting first systemic treatment for EBC or ABC.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment reality
Time frame: 5 years
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.
5 secondary outcomes
Best Response
Time frame: 5 years
Progression-free survival
Time frame: 5 years
Overall survival
Time frame: 5 years
Health-related quality of life (Patient-reported outcome)
Time frame: 3.5 years
Disease-free survival
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Results publication: PubMed 41851017Marschner 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.
- Results publication: PubMed 39707595Thill 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.
- Results publication: PubMed 36807725Thill 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Norbert Marschner, MD study chair
Praxis für interdisziplinäre Onkologie & Hämatologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by iOMEDICO AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Kruggel (+49 761 15242-0, info@iomedico.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment reality (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03417115, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.