Clinical trial · Interventional
Metastases Directed Therapy for Oligometastatic Breast Cancer
Role of Metastases Directed Radiotherapy in Addition to Standard of Care Systemic Treatment in the Management of Extracranial Oligometastatic Breast Cancer
- 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)
This is a phase III randomized study evaluating the benefit from adding metastases directed therapy and locoregional treatment of the primary in breast cancer patients diagnosed with de novo oligometastatic disease patients will be randomized to receive the standard of care (SOC) treatment vs. systemic treatment + Stereotactic Ablative Radiation Therapy. Responders will be randomized to either undergo loco-regional management of the primary tumor or not
Conditions
Conditions (3)
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 |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Locoregional treatment | Procedure | — | UNRESOLVED |
| Standard of Care | Other | — | UNRESOLVED |
| Stereotactic Ablative Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Standard of Care
- description
- systemic and palliative treatment according to physician discretion
- interventionNames
- Other: Standard of Care
- type
- EXPERIMENTAL
- label
- Metastases Directed Therapy
- description
- SABR for all metastatic sites followed by systemic treatment for 6 months
- interventionNames
- Radiation: Stereotactic Ablative Radiation Therapy
- type
- EXPERIMENTAL
- label
- Locoregional Treatment of the Primary
- description
- patients who respond to MDT and ST will be randomized to undergo loco-regional treatment or not
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients aged 18 to 70 years. * Pathological evidence of breast cancer, any grade, any T stage. * Radiological (at least) evidence of metastatic activity with maximum number of 5 extracranial lesions. * Performance status ≤ 2 * No pre-existing conditions that may prohibit radiotherapy. Exclusion Criteria: •.Pregnant and lactating women. * Prior radiotherapy to affected site(s) in less than a year. * Active Connective tissue diseases (e.g Rheumatoid Arthritis). * Progression to widespread metastatic disease * Cases with brain metastasis
References
Publications (0)
Data not yet available