Breast Stereotactic Radiotherapy to Primary Tumors in Metastatic Patients
NCT ID: NCT05229575
Last Updated: 2022-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2020-07-10
2023-04-10
Brief Summary
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* radio-biological advantage of a short highly effective treatment schedule
* possibility of preventing lesions to become symptomatic
* possibility of continuing systemic treatment without interruption
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Stereotactic Body Radiation Therapy (SBRT)
Patients undergo 5 fractions of image-guided stereotactic body radiation therapy to primary breast tumor over 2 weeks
Stereotactic Body Radiation Therapy (SBRT)
Undergo SBRT
Interventions
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Stereotactic Body Radiation Therapy (SBRT)
Undergo SBRT
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Campus Bio-Medico University
OTHER
Responsible Party
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Locations
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Università Campus Biomedico
Roma, , Italy
Countries
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Central Contacts
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Facility Contacts
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Sara Ramella
Role: primary
References
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Ippolito 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.
Other Identifiers
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46.20 PAR ComEt CBM
Identifier Type: -
Identifier Source: org_study_id
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