Breast Stereotactic Radiotherapy to Primary Tumors in Metastatic Patients (BoMB)

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 Overview

• Status: Recruiting
• Conditions: Stage IV Breast Cancer
• Intervention / Treatment: Radiation: Stereotactic Body Radiation Therapy (SBRT)

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edy Ippolito, MD; Phone Number: +3906225418011; Email: e.ippolito@unicampus.it

Study Locations

• Italy
  • Roma, Italy
    • Recruiting
    • Università Campus Biomedico
    • Contact: Sara Ramella

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Stereotactic Body Radiation Therapy (SBRT); Patients undergo 5 fractions of image-guided stereotactic body radiation therapy to primary breast tumor over 2 weeks	Radiation: Stereotactic Body Radiation Therapy (SBRT); Undergo SBRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary breast tumor local failure	2 years local failure probability of treated primary tumor predicted by CT planning images	2 years

Collaborators and Investigators

• Sponsor: Campus Bio-Medico University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 10, 2020
• Primary Completion (ANTICIPATED): October 10, 2022
• Study Completion (ANTICIPATED): April 10, 2023

Study Registration Dates

• First Submitted: January 7, 2022
• First Submitted That Met QC Criteria: February 4, 2022
• First Posted (ACTUAL): February 8, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 46.20 PAR ComEt CBM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No