Breast Stereotactic Radiotherapy to Primary Tumors in Metastatic Patients

Campus Bio-Medico University30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stage IV Breast Cancer

Interventions

Stereotactic Body Radiation Therapy (SBRT)RADIATION

Undergo SBRT

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Università Campus Biomedico

Roma, Italy

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

Rate of long-term adverse events

scored according to the NCI CTCAE v. 4.2

Time frame: 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

Time frame: 2 years

QoL

scored according to the EORTC quality of life questionnaire (QLQ) in breast cancer patients (EORTC QLQ-C30 / BR23)

Time frame: 2 years

Primary breast tumor best response

evaluated according to Response Evaluation Criteria in Solid Tumours (RECIST v1.1)

Time frame: 2 years

Central Contacts

Edy Ippolito, MD

CONTACT

+3906225418011 e.ippolito@unicampus.it

Data from ClinicalTrials.gov

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