NCT05229575

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2023

Completed
Last Updated

February 8, 2022

Status Verified

February 1, 2022

Enrollment Period

2.3 years

First QC Date

January 7, 2022

Last Update Submit

February 4, 2022

Conditions

Stage IV Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Rate of long-term adverse events

    2 years

  • Breast Cosmesis

    2 years

  • QoL

    2 years

  • Primary breast tumor best response

    2 years

Other Outcomes (1)

  • Primary breast tumor local failure

    2 years

Study Arms (1)

Stereotactic Body Radiation Therapy (SBRT)

EXPERIMENTAL

Patients undergo 5 fractions of image-guided stereotactic body radiation therapy to primary breast tumor over 2 weeks

Radiation: Stereotactic Body Radiation Therapy (SBRT)

Interventions

Stereotactic Body Radiation Therapy (SBRT)RADIATION

Undergo SBRT

Stereotactic Body Radiation Therapy (SBRT)

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università Campus Biomedico

Roma, Italy

RECRUITING

Related Publications (1)

  • Ippolito E, Silipigni S, Pantano F, Matteucci P, Carrafiello S, Marrocco M, Alaimo R, Palumbo V, Fiore M, Orsaria P, D'Angelillo RM, Altomare V, Tonini G, Ramella S. BOMB trial: First results of stereotactic radiotherapy to primary breast tumor in metastatic breast cancer patients. Front Oncol. 2023 Mar 17;13:1062355. doi: 10.3389/fonc.2023.1062355. eCollection 2023.

    PMID: 37007063DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Edy Ippolito, MD

CONTACT

+3906225418011e.ippolito@unicampus.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2022

First Posted

February 8, 2022

Study Start

July 10, 2020

Primary Completion

October 10, 2022

Study Completion

April 10, 2023

Last Updated

February 8, 2022

Record last verified: 2022-02

Locations

IT(1)