Breast Stereotactic Radiotherapy to Primary Tumors in Metastatic Patients

Stage IV Breast Cancer Clinical Trial

— BoMB  

Official title:

Breast Stereotactic Radiotherapy to Primary Tumors in Metastatic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05229575
• Other study ID #: 46.20 PAR ComEt CBM
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Stage IV Breast Cancer

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