Radiotherapy combined with standard therapy for 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

This study is testing if adding targeted radiation therapy to regular treatment can help people with oligometastatic breast cancer live longer without their cancer getting worse.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 564 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: University Hospital Schleswig-Holstein (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 14 sites (Mannheim, Baden-Württemberg and 13 other locations)
• Trial ID: NCT04495309 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of adding local metastases-directed radiotherapy to standard systemic therapy in patients with oligometastatic breast cancer. It aims to evaluate the impact on progression-free survival and quality of life. The trial employs various radiotherapy techniques, including ablative radiotherapy and three-dimensional conformal radiation therapy, tailored to the size and location of the metastases. Participants will be randomized to receive either the combined treatment or standard therapy alone.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with up to 5 clinically manifest metastases and a maximum of 3 cerebral metastases.

Not a fit: Patients with symptomatic metastases requiring immediate local therapy or those who have previously received conflicting radiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve progression-free survival and quality of life for patients with oligometastatic breast cancer.

How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Incapacity to contract or lack of informed consent
* Pregnancy and lactation

Where this trial is running

Mannheim, Baden-Württemberg and 13 other locations

• Universitätsmedizin Mannheim Klinik für Strahlentherapie und Radioonkologie — Mannheim, Baden-Württemberg, Germany (Recruiting)
• Praxis für Strahlentherapie und Radioonkologie am Krankenhaus Weilheim — Weilheim, Bayern, Germany (Recruiting)
• Klinikum Frankfurt (Oder) GmbH Klinik für Strahlentherapie/Radioonkologie — Frankfurt (Oder), Brandenburg, Germany (Recruiting)
• Universitätsklinikum Marburg Klinik für Strahlentherapie und Radioonkologie — Marburg, Hessen, Germany (Recruiting)
• GSR Hameln im Sana Klinikum Hameln-Pyrmont — Hameln, Niedersachsen, Germany (Recruiting)
• Gemeinschaftspraxis für Strahlentherapie — Hildesheim, Niedersachsen, Germany (Recruiting)
• MVZ WOB GmbH Strahlentherapie — Wolfsburg, Niedersachsen, Germany (Recruiting)
• Strahlentherapie Bocholt Gemeinschaftspraxis und Belegabteilung am St.-Agnes-Hospital — Bocholt, Nordrhein-Westfalen, Germany (Recruiting)
• Evangelische Kliniken Gelsenkirchen Klinik für Strahlentherapie — Gelsenkirchen, Nordrhein-Westfalen, Germany (Recruiting)
• Xcare Praxis für Strahlentherapie Saarlouis am Marienkrankenhaus — Saarlouis, Saarland, Germany (Recruiting)
• Städtisches Klinikum Dresden, Strahlentherapie — Dresden, Sachsen, Germany (Recruiting)
• Heinrich-Braun-Klinikum Zwickau gGmbH Klinik für Strahlentherapie und Radioonkologie — Zwickau, Sachsen, Germany (Recruiting)
• Christian-Albrechts-University Kiel, University Medical Center Schleswig-Holstein, Campus Kiel — Kiel, Schleswig-Holstein, Germany (Recruiting)
• Johanniter-Krankenhaus Genthin-Stendal — Stendal, Germany (Recruiting)

Study contacts

• Study coordinator: Kathrin Dellas, Professor

Conditions Metastatic Breast Cancer; Oligometastatic Breast Cancer; Radiotherapy; Progression-free survival