Stage IV Breast Cancer
Conditions
Brief summary
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
Interventions
RADIATIONStereotactic Body Radiation Therapy (SBRT)
Undergo SBRT
Sponsors
Campus Bio-Medico University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum tolerated dose of stereotactic body radiotherapy (SBRT) | 6 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of long-term adverse events | 2 years | scored according to the NCI CTCAE v. 4.2 |
| Breast Cosmesis | 2 years | scored according to the European Organization for Research and Treatment of Cancer (EORTC) Cosmetic Rating System for Breast Cancer for the evaluation of cosmetics (score 1 to 4, no difference-large difference by comparing the treated breast to the controlateral breast) and carried out separately by the doctor and the patient |
| QoL | 2 years | scored according to the EORTC quality of life questionnaire (QLQ) in breast cancer patients (EORTC QLQ-C30 / BR23) |
| Primary breast tumor best response | 2 years | evaluated according to Response Evaluation Criteria in Solid Tumours (RECIST v1.1) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Primary breast tumor local failure | 2 years | 2 years local failure probability of treated primary tumor predicted by CT planning images |
Countries
Italy
Contacts
Primary ContactEdy Ippolito, MD
Outcome results
None listed