Breast Stereotactic Radiotherapy to Primary Tumors in Metastatic Patients (BoMB)

Campus Bio-Medico University of Rome

Status: Unknown

Conditions: Stage IV Breast Cancer

Treatments: Radiation: Stereotactic Body Radiation Therapy (SBRT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05229575

46.20 PAR ComEt CBM

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Stereotactic Body Radiation Therapy (SBRT)

Experimental group

Description:

Patients undergo 5 fractions of image-guided stereotactic body radiation therapy to primary breast tumor over 2 weeks

Treatment:

Radiation: Stereotactic Body Radiation Therapy (SBRT)