Stage IV Breast CancerBoMBNCT05229575
Breast Stereotactic Radiotherapy to Primary Tumors in Metastatic Patients
A study testing Stereotactic Body Radiation Therapy (SBRT) in people with Stage IV Breast Cancer, run by Campus Bio-Medico University at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stage IV Breast Cancer
- What is being tested?
- Stereotactic Body Radiation Therapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jul 2020to 10 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Università Campus Biomedico
Roma
Sara Ramella
About this study
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
- Conditions
- Stage IV Breast Cancer
- Being tested
- Stereotactic Body Radiation Therapy (SBRT)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy (SBRT)Radiation
Undergo SBRT
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | Experimental | Patients undergo 5 fractions of image-guided stereotactic body radiation therapy to primary breast tumor over 2 weeks Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (4)
Rate of long-term adverse events
scored according to the NCI CTCAE v. 4.2
Measured: 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
Measured: 2 years
QoL
scored according to the EORTC quality of life questionnaire (QLQ) in breast cancer patients (EORTC QLQ-C30 / BR23)
Measured: 2 years
Primary breast tumor best response
evaluated according to Response Evaluation Criteria in Solid Tumours (RECIST v1.1)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start10 Jul 2020
- Primary completion10 Oct 2022 (estimated)
- Study completion10 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stage IV Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229575
- Sponsor's protocol ID
- 46.20 PAR ComEt CBM
- Acronym
- BoMB
- Status last verified
- Feb 2022
- First submitted
- 7 Jan 2022
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37007063
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Stereotactic Radiotherapy to Primary Tumors in Metastatic Patients
- ClinicalTrials.gov ID
- NCT05229575
- Acronym / sponsor ID
- BoMB / 46.20 PAR ComEt CBM
- Conditions
- Stage IV Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 10 Oct 2022 (estimated)
- Study completion
- 10 Apr 2023 (estimated)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | Experimental | Radiation: Stereotactic Body Radiation Therapy (SBRT)Patients undergo 5 fractions of image-guided stereotactic body radiation therapy to primary breast tumor over 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT)Undergo SBRT | Radiation | Stereotactic Body Radiation Therapy (SBRT) |
Primary outcome
Maximum tolerated dose of stereotactic body radiotherapy (SBRT)
Time frame: 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
4 secondary outcomes
Rate of long-term adverse events
Time frame: 2 years
Breast Cosmesis
Time frame: 2 years
QoL
Time frame: 2 years
Primary breast tumor best response
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Derived from this study: PubMed 37007063Ippolito 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Body Radiation Therapy (SBRT) in people with Stage IV Breast Cancer, run by Campus Bio-Medico University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edy Ippolito, MD (+3906225418011, e.ippolito@unicampus.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose of stereotactic body radiotherapy (SBRT) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05229575, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.