Clinical trial · Interventional
SABR PRIMER - Evaluating Stereotactic Ablative Radiotherapy for Primary and Regional Breast Tumors
A Phase II Trial Evaluating Stereotactic Ablative Radiotherapy for Primary and Regional Breast Tumors (SABR-PRIMeR)
- 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 study is being done to determine if stereotactic ablative radiotherapy (SABR) can control tumour growth for patients with metastatic breast cancer. Secondary objectives will be overall survival, progression-free survival and time to switch of next line of systemic therapy. Radiation-related adverse events will be assess, with a specific focus on dermatitis, lymphedema and brachial plexopathy. The exploratory objective is to correlate toxicities and outcomes with peripheral blood biomarkers and circulating tumor DNA to potentially help predict responses in future patients receiving combined therapy.
Conditions
Conditions (2)
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 |
| Metastases | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SABR | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- SABR treatment to Whole breast +/- regional lymph nodes
- interventionNames
- Radiation: SABR
Primary outcomes (1)
- measure
- Locoregional Control
- timeFrame
- 2 Years
- description
- Assess median, 1-year and 2-year locoregional control
Secondary outcomes (4)
- measure
- Overall survival
- timeFrame
- 2 Years
- description
- Assess median, 1-year and 2-year overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pathologically confirmed AJCC 7th/8th edition Stage IV invasive ductal carcinoma or invasive lobular carcinoma of the breast. 2. Measurable disease in the breast, suitable to receive radiotherapy. 3. Receiving or planned to receive systemic therapy. a. The following should be held for the duration of treatment: cytotoxic chemotherapy, CDK4/6 inhibitors, T-DXd 4. Patients are allowed to have SABR for oligometastatic disease as clinically indicated 5. Age 18 or older 6. ECOG Performance Status 0-2 7. Life expectancy greater than 6 months 8. Able and willing to provide informed consent 9. Able to complete patient reported outcome questionnaires Exclusion Criteria: 1. Contraindications to radiotherapy, including a history of SLE, systemic scleroderma, IPF, ataxia telangiectasia, pregnancy 2. Previous history of locoregional radiotherapy to the ipsilateral breast
References
Publications (0)
Data not yet available