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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05229575
Other study ID # 46.20 PAR ComEt CBM
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 10, 2020
Est. completion date April 10, 2023

Study information

Verified date February 2022
Source Campus Bio-Medico University
Contact Edy Ippolito, MD
Phone +3906225418011
Email e.ippolito@unicampus.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date April 10, 2023
Est. primary completion date October 10, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
Stereotactic Body Radiation Therapy (SBRT)
Undergo SBRT

Locations

Country Name City State
Italy Università Campus Biomedico Roma

Sponsors (1)

Lead Sponsor Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Other Primary breast tumor local failure 2 years local failure probability of treated primary tumor predicted by CT planning images 2 years
Primary 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 Rate of long-term adverse events scored according to the NCI CTCAE v. 4.2 2 years
Secondary 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
Secondary QoL scored according to the EORTC quality of life questionnaire (QLQ) in breast cancer patients (EORTC QLQ-C30 / BR23) 2 years
Secondary Primary breast tumor best response evaluated according to Response Evaluation Criteria in Solid Tumours (RECIST v1.1) 2 years
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