Clinical trial · Observational
Breast Cancer Registry Platform
Treatment and Outcome of Patients With Breast Cancer: Clinical Research Platform for Real World Data
NCT03417115CI-TRIAL-00113822OPALrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (6)
- label
- Advanced breast cancer - Her2 positive
- description
- Patients with HER2-positive advanced breast cancer
- label
- Advanced breast cancer - triple negative
- description
- Patients with triple negative advanced breast cancer
- label
- Advanced breast cancer - HR positive, Her2 negative
- description
- Patients with HR positive, Her2 negative advanced breast cancer
- label
- Early breast cancer - HER2 positive
- description
- Patients with HER2 positive early breast cancer
- label
- Early breast cancer - triple negative
- description
- Patients with triple negative early breast cancer
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- RESULTMarschner 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. PMID 41851017
- RESULTThill 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. PMID 39707595
- RESULTThill 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. PMID 36807725