Clinical trial · Interventional
Stereotactic Body Radiation Therapy for Breast Cancer
A Phase I-II Study of Stereotactic Body Radiation Therapy for Breast Cancer (SBRT Breast)
- 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 prospective, single institution, phase I-II study of stereotactic body radiotherapy (SBRT) for unresected breast cancer. Twenty-four patients with advanced breast cancer who are not candidates for surgery (metastatic disease, unresectable, medically inoperable) or decline surgery will be enrolled in a prospective study using SBRT (4 fractions of radiation therapy over 12-15 days) as the primary treatment modality.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SBRT to the Primary Breast Tumour
- description
- SBRT to the breast using 4 sequentially escalating dose levels from 9Gy to 12 Gy.
- interventionNames
- Radiation: SBRT
Primary outcomes (1)
- measure
- Acute toxicity
- timeFrame
- 12 weeks post treatment
- description
- Incidence of side effects /toxicity associated with SBRT to the breast, during and in the three months following treatment using CTCAE v4.0
Secondary outcomes (5)
- measure
- Breast Symptom Scores
- timeFrame
- 2 years post treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Histologically confirmed diagnosis of invasive breast carcinoma of non-lobular histology. Unifocal tumour Previously assessed by a breast surgeon and medical oncologist, with no surgery being recommended at time of enrollment. Primary breast and axillary surgery not recommended/performed due to any of the following: * distant metastatic disease * unresectable T4 disease and/or * medically inoperable and/or * patient declined breast surgery Stages T1-T4, N1-N2, M0-M1 disease Ability to attend radiation planning and therapy, able to attend for follow-up care Able to provide written informed consent. Exclusion Criteria: Received chemotherapy within 3 weeks prior to breast SBRT. (Concurrent endocrine therapy is permitted) Multifocal or multicentric tumours. Ipsilateral supraclavicular or infraclavicular nodal disease \>= 1cm size that is at the level of or superior to the brachial plexus Unable to meet the brachial plexus dose constraints despite compromising coverage of target volumes - as per the discretion of the treating physician Treatment target volume estimated to occupy \> 50% of the ipsilateral whole breast volume. Locally recurrent breast cancer, with previous radiotherapy to the breast, or previous lumpectomy or mastectomy. Ipsilateral breast implant. Serious non-malignant disease that precludes definitive surgical or radiation treatment (e.g. scleroderma, systemic lupus erythematosus, cardiovascular/pulmonary/renal disease). Women who are pregnant or lactating. Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol
References
Publications (0)
Data not yet available