Breast Stereotactic Radiotherapy to Primary Tumors in Metastatic Patients

Not Applicable

• Conditions: Stage IV Breast Cancer
• Interventions: Radiation: Stereotactic Body Radiation Therapy (SBRT)

• Registration Number: NCT05229575
• Lead Sponsor: Campus Bio-Medico University

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-10
• Study First Submitted: 2022-01-07
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-04
• Last Update Submitted: 2022-02-04
• Study First Posted: 2022-02-08
• Last Update Posted: 2022-02-08
• Primary Completion: 2022-10-10
• Study Completion: 2023-04-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stereotactic Body Radiation Therapy (SBRT)	Stereotactic Body Radiation Therapy (SBRT)	Patients undergo 5 fractions of image-guided stereotactic body radiation therapy to primary breast tumor over 2 weeks

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose of stereotactic body radiotherapy (SBRT)	6 months	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Università Campus Biomedico; 🇮🇹 Roma, Italy