Clinical trial · Interventional
Breast Stereotactic Radiotherapy to Primary Tumors in Metastatic Patients
NCT05229575CI-TRIAL-00056368BoMBunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 dose escalation study involving stage IV breast cancer patients not progressing after 6 months of first line systemic treatment. Potential advantages of stereotactic body radiotherapy (SBRT) in treating breast primary tumor in metastatic breast cancer are: * radio-biological advantage of a short highly effective treatment schedule * possibility of preventing lesions to become symptomatic * possibility of continuing systemic treatment without interruption
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 |
|---|---|---|---|
| Stage IV Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stereotactic Body Radiation Therapy (SBRT)
- description
- Patients undergo 5 fractions of image-guided stereotactic body radiation therapy to primary breast tumor over 2 weeks
- interventionNames
- Radiation: Stereotactic Body Radiation Therapy (SBRT)
Primary outcomes (1)
- measure
- Maximum tolerated dose of stereotactic body radiotherapy (SBRT)
- timeFrame
- 6 months
- description
- the dose of radiotherapy associated with a ≤ 20% rate pre-specified treatment-related dose -limiting toxicity (DLT) occurring within 6 months from the start of treatment. DLT is defined as any grade 3 or worse toxicity according to CTCAE v.4 related to the following specific symptoms: * Radiation dermatitis grade \> 3 * Breast pain grade 3 * Breast infection grade \> 3 * Breast asymmetry grade 3 * Fibrosis grade \> 3 * Skin atrophy grade 3 * Rib fracture grade 3 * Chest wall pain grade 3
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age: 18 years or older * Histologically confirmed diagnosis of invasive breast carcinoma (biological immunohistochemical profile: luminal and/or human epidermal growth factor receptor 2 positive) * Distant metastatic disease not progressing after 6 months of systemic therapy * Zubrod Performance status of 0-1 * Unifocal tumour \< 5 cm tumor size * Tumor CT or 18-labeled fluorodeoxyglucose positron emission tomography (5FDG-PET) detectable * No surgery being recommended at time of enrollment. Exclusion Criteria: * prior radiotherapy * active systemic lupus erythematosus, or any history of scleroderma, dermatomyositis with active rash * Women who are pregnant or lactating. * Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol
References
Publications (1)
- DERIVEDIppolito E, Silipigni S, Pantano F, Matteucci P, Carrafiello S, Marrocco M, Alaimo R, Palumbo V, Fiore M, Orsaria P, D'Angelillo RM, Altomare V, Tonini G, Ramella S. BOMB trial: First results of stereotactic radiotherapy to primary breast tumor in metastatic breast cancer patients. Front Oncol. 2023 Mar 17;13:1062355. doi: 10.3389/fonc.2023.1062355. eCollection 2023. PMID 37007063