Breast Stereotactic Radiotherapy to Primary Tumors in Metastatic Patients

Study Overview
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Brief Summary
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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

Official Title
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Breast Stereotactic Radiotherapy to Primary Tumors in Metastatic Patients

Conditions
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Stage IV Breast Cancer

Intervention / Treatment
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* Radiation: Stereotactic Body Radiation Therapy (SBRT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stereotactic Body Radiation Therapy (SBRT)<br>Patients undergo 5 fractions of image-guided stereotactic body radiation therapy to primary breast tumor over 2 weeks | Radiation: Stereotactic Body Radiation Therapy (SBRT)<br>* Undergo SBRT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose of stereotactic body radiotherapy (SBRT) | 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of long-term adverse events | scored according to the NCI CTCAE v. 4.2 | 2 years | 
| Breast Cosmesis | 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 | 2 years | 
| QoL | scored according to the EORTC quality of life questionnaire (QLQ) in breast cancer patients (EORTC QLQ-C30 / BR23) | 2 years | 
| Primary breast tumor best response | evaluated according to Response Evaluation Criteria in Solid Tumours (RECIST v1.1) | 2 years |