Clinical trial · Interventional
A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer
Stereotactic Body Radiation Therapy (SBRT) to Extend the Benefit of Systemic Therapy in Patients With Solitary Disease Progression
- 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 this study is to see if using Stereotactic Body Radiation Therapy/SBRT to treat a single metastatic site where cancer has worsened may be an effective treatment for people with oligometastatic breast cancer. Participants will stay on their usual drug therapy while they receive SBRT. This combination of SBRT to a single metastatic site and usual drug therapy may prevent participants' cancer from worsening in other metastatic sites or spreading.
Conditions
Conditions (6)
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 |
| ER+ Breast Cancer | — | UNRESOLVED | — |
| HER2+ Breast Cancer | — | UNRESOLVED | — |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Breast Carcinoma | Breast Carcinoma | CURATED_BROADER | 0.78 |
| Oligometastatic Breast Carcinoma | Oligometastatic Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic body radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Participants with oligometastatic breast cancer
- description
- Participants with oligometastatic breast cancer with isolated progression after sustained (\>=6 month) response to systemic therapy. Participants will receive image guided, SBRT to the progressive lesion identified on imaging. Participants will be maintained on their existing line of systemic therapy. Systemic therapy will be held during days of radiation and resume following completion of radiation.
- interventionNames
- Radiation: Stereotactic body radiotherapy
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- 3 months from start of SBRT delivery
- description
- The primary objective is to assess progression free survival, defined as systemic progression or death, within 3 months from start of Stereotactic Body Radiation Therapy/SBRT delivery.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 or older * Willing and able to provide informed consent * Metastatic breast cancer, biopsy proven * ER+/HER2-, defined as \>5% ER+ staining * HER2+ (regardless of ER status), including HER2-low and high expressors * History of at least 6 months, sustained response to systemic therapy (clinically or radiographically defined as complete or stable response without progression) * Isolated site of disease progression on FDG PET scan * Consented to 12-245 * ECOG performance status 0-1 Exclusion Criteria: * Pregnancy * Serious medical comorbidity precluding radiation, including connective tissue disorders * Intracranial disease (including previous intracranial involvement) * Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.
References
Publications (0)
Data not yet available