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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
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

Full criteria on ClinicalTrials.gov

Sites (14)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Strahlentherapie Bocholt Gemeinschaftspraxis und Belegabteilung am St.-Agnes-Hospital
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BocholtGermanyUnknown status
Städtisches Klinikum Dresden, Strahlentherapie
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DresdenGermanyUnknown status
Klinikum Frankfurt (Oder) GmbH Klinik für Strahlentherapie/Radioonkologie
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Frankfurt (Oder)GermanyUnknown status
Evangelische Kliniken Gelsenkirchen Klinik für Strahlentherapie
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GelsenkirchenGermanyUnknown status
GSR Hameln im Sana Klinikum Hameln-Pyrmont
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HamelinGermanyUnknown status
Gemeinschaftspraxis für Strahlentherapie
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HildesheimGermanyUnknown status
Christian-Albrechts-University Kiel, University Medical Center Schleswig-Holstein, Campus Kiel
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KielGermanyUnknown status
Universitätsmedizin Mannheim Klinik für Strahlentherapie und Radioonkologie
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MannheimGermanyUnknown status
Universitätsklinikum Marburg Klinik für Strahlentherapie und Radioonkologie
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MarburgGermanyUnknown status
Xcare Praxis für Strahlentherapie Saarlouis am Marienkrankenhaus
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SaarlouisGermanyUnknown status
Johanniter-Krankenhaus Genthin Stendal
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StendalGermanyUnknown status
Praxis für Strahlentherapie und Radioonkologie am Krankenhaus Weilheim
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WeilheimGermanyUnknown status
MVZ WOB GmbH Strahlentherapie
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WolfsburgGermanyUnknown status
Heinrich-Braun-Klinikum Zwickau gGmbH Klinik für Strahlentherapie und Radioonkologie
Coordinator of this site? Confirm its status
ZwickauGermanyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.