NCT04495309Completed
Metastases-directed Radiotherapy in Addition to Standard Systemic Therapy in Patients With Oligometastatic Breast Cancer
Effectiveness and Tolerability of Metastases-directed Radiotherapy in Addition to Standard Systemic Therapy in Patients With Oligometastatic Breast Cancer: A Randomized Controlled Multinational and Multicenter Clinical Trial
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
The prognosis for patients with metastatic breast cancer has improved continuously. Systemic therapies alone are not able to cure the disease permanently. Investigators initiated this randomized controlled multinational and multicenter clinical trial to analyse the impact of a local metastases-directed radiotherapy in addition to standard systemic therapy in patients with oligometastatic breast cancer on progression-free survival and quality of life.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 87 (actual)
- First submitted
- 9 Jun 2020
- Start date
- 5 Mar 2021
- Primary completion date
- 3 Jun 2025
- Lead sponsor
- University Hospital Schleswig-Holstein
- Diseases
- Metastatic breast cancer
- NCT number
- NCT04495309
What you commit to
- Study type: Interventional
- Participants enrolled: 87
- From 5 Mar 2021 to the primary completion date, 3 Jun 2025
- 14 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous radiotherapy, if this interferes with treatment within the scope of the study
- symptomatic metastases requiring local therapy of all metastases (e.g. pain radiation), a radiation indication (or other local therapy) for individual metastases is not a criterion for exclusion
- known central nervous system (CNS) metastasis without extracerebral metastasis (in these cases, immediate local therapy is mandatory)
- more than three known CNS metastases (no indication for purely local therapy of only the metastases, primary whole brain radiation is indicated)
- multifocal metastasis in one organ with impossibility to comply with the dose constraints for this organ (e.g., no indication for local therapy of only the metastases, primary whole brain radiation is indicated) (e.g. in the liver)
- exclusively regional lymph node metastasis without haematogenic metastases (in these cases local therapy is clearly indicated according to guidelines)
- relevant comorbidity, if this results in restrictions for further therapy
Other
- Incapacity to contract or lack of informed consent
- Pregnancy and lactation
Who the study is looking for
- Metastasized breast cancer - up to 5 clinically manifest (new, progressive, persistent) metastases (a lymph node metastasis and a circumscribed local recurrence are each considered as one metastasis, i.e. also locoregional recurrent breast carcinomas with additional hematogenic metastasis possible)
- maximum of 3 cerebral metastases known
- indication for palliative drug therapy (endocrine therapy and/or chemotherapy and/or treatment with other substances) given according to guidelines (1st-line or further therapy lines, a special regime is not specified)
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
- local radiation of all metastases possible
- presentation of a written declaration of consent
- patient ≥ 18 years
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Strahlentherapie Bocholt Gemeinschaftspraxis und Belegabteilung am St.-Agnes-Hospital Coordinator of this site? Confirm its status | Bocholt | Germany | Unknown status |
| Städtisches Klinikum Dresden, Strahlentherapie Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| Klinikum Frankfurt (Oder) GmbH Klinik für Strahlentherapie/Radioonkologie Coordinator of this site? Confirm its status | Frankfurt (Oder) | Germany | Unknown status |
| Evangelische Kliniken Gelsenkirchen Klinik für Strahlentherapie Coordinator of this site? Confirm its status | Gelsenkirchen | Germany | Unknown status |
| GSR Hameln im Sana Klinikum Hameln-Pyrmont Coordinator of this site? Confirm its status | Hamelin | Germany | Unknown status |
| Gemeinschaftspraxis für Strahlentherapie Coordinator of this site? Confirm its status | Hildesheim | Germany | Unknown status |
| Christian-Albrechts-University Kiel, University Medical Center Schleswig-Holstein, Campus Kiel Coordinator of this site? Confirm its status | Kiel | Germany | Unknown status |
| Universitätsmedizin Mannheim Klinik für Strahlentherapie und Radioonkologie Coordinator of this site? Confirm its status | Mannheim | Germany | Unknown status |
| Universitätsklinikum Marburg Klinik für Strahlentherapie und Radioonkologie Coordinator of this site? Confirm its status | Marburg | Germany | Unknown status |
| Xcare Praxis für Strahlentherapie Saarlouis am Marienkrankenhaus Coordinator of this site? Confirm its status | Saarlouis | Germany | Unknown status |
| Johanniter-Krankenhaus Genthin Stendal Coordinator of this site? Confirm its status | Stendal | Germany | Unknown status |
| Praxis für Strahlentherapie und Radioonkologie am Krankenhaus Weilheim Coordinator of this site? Confirm its status | Weilheim | Germany | Unknown status |
| MVZ WOB GmbH Strahlentherapie Coordinator of this site? Confirm its status | Wolfsburg | Germany | Unknown status |
| Heinrich-Braun-Klinikum Zwickau gGmbH Klinik für Strahlentherapie und Radioonkologie Coordinator of this site? Confirm its status | Zwickau | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.