Breast CancerSIBNCT07407192
Toxicity Outcomes of Simultaneous Integrated Boost in Adjuvant Breast Radiotherapy Acronym
A study testing Adjuvant Breast Radiotherapy With Simultaneous Integrated Boost (SIB) in people with Breast Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial summary
This prospective study systematically evaluates toxicity outcomes in breast cancer patients treated with adjuvant radiotherapy using the simultaneous integrated boost (SIB) technique after breast-conserving surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Adjuvant Breast Radiotherapy With Simultaneous Integrated Boost (SIB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jan 2019to 31 Dec 2024
- 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
- Female patients with histologically confirmed breast cancer
- Status post breast-conserving surgery (lumpectomy)
- Planned adjuvant whole-breast radiotherapy with simultaneous integrated boost (SIB) to the tumor bed
- Age ≥ 18 years
- Ability to provide informed consent
Who cannot join
- Prior radiotherapy to the breast or thoracic region
- Mastectomy (no breast-conserving surgery)
- Pregnancy or breastfeeding
- Inability to complete planned radiotherapy or follow-up assessments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Toxicity Outcomes of Simultaneous Integrated Boost as Part of Adjuvant Radiotherapy in Breast Cancer Patients After Breast-Conserving Surgery
This prospective study systematically evaluates toxicity outcomes in breast cancer patients treated with adjuvant radiotherapy using the simultaneous integrated boost (SIB) technique after breast-conserving surgery. The aim is to monitor acute and late treatment-related side effects during implementation of this radiotherapy approach and to compare institutional toxicity outcomes with published data in the literature.
Read the detailed description
Breast cancer patients undergoing breast-conserving surgery are treated with adjuvant radiotherapy using either standard fractionation or hypofractionation combined with a simultaneous integrated boost (SIB) to the tumor bed. This prospective study includes systematic collection and grading of acute and late radiation-related toxicity outcomes in order to evaluate the safety of the implemented protocol and to assess whether toxicity rates are comparable to those reported in published clinical studies. The results will support optimization and quality assurance of the radiotherapy technique in routine clinical practice.
- Conditions
- Breast Cancer
- Being tested
- Adjuvant Breast Radiotherapy With Simultaneous Integrated Boost (SIB)
- Keywords
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant Breast Radiotherapy With Simultaneous Integrated Boost (SIB)Radiation
Adjuvant whole-breast radiotherapy after breast-conserving surgery with a simultaneous integrated boost (SIB) dose delivered to the tumor bed during the same treatment sessions. Treatment is delivered using either standard fractionation or hypofractionation, according to institutional protocol.
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant Radiotherapy With Simultaneous Integrated Boost (SIB) | Experimental | Breast cancer patients treated with breast-conserving surgery receive adjuvant radiotherapy to the whole breast with a simultaneous integrated boost (SIB) to the tumor bed, using either standard fractionation or hypofractionation. Acute and late toxicity outcomes are prospectively recorded. Receives: Radiation: Adjuvant Breast Radiotherapy With Simultaneous Integrated Boost (SIB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Radiation Toxicity (CTCAE)
Incidence and severity of acute radiotherapy-related toxicity assessed during treatment and shortly after completion, graded according to Common Terminology Criteria for Adverse Events (CTCAE).
Measured: From start of radiotherapy up to 3 months after completion of radiotherapy
Acute Radiation Toxicity (CTCAE)
Measured: From start of radiotherapy up to 3 months after completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 Jan 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Model description
- Patients with breast cancer after breast-conserving surgery receive adjuvant radiotherapy with a simultaneous integrated boost (SIB) to the tumor bed. Acute and late toxicity outcomes are prospectively recorded.
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407192
- Sponsor's protocol ID
- OI-BREAST-SIB-2019
- Other IDs
- ERIDEK-0045/2019
- Acronym
- SIB
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toxicity Outcomes of Simultaneous Integrated Boost as Part of Adjuvant Radiotherapy in Breast Cancer Patients After Breast-Conserving Surgery
- ClinicalTrials.gov ID
- NCT07407192
- Acronym / sponsor ID
- SIB / OI-BREAST-SIB-2019
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 12 Feb 2026 (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 prospective study systematically evaluates toxicity outcomes in breast cancer patients treated with adjuvant radiotherapy using the simultaneous integrated boost (SIB) technique after breast-conserving surgery. The aim is to monitor acute and late treatment-related side effects during implementation of this radiotherapy approach and to compare institutional toxicity outcomes with published data in the literature.
Detailed description
Breast cancer patients undergoing breast-conserving surgery are treated with adjuvant radiotherapy using either standard fractionation or hypofractionation combined with a simultaneous integrated boost (SIB) to the tumor bed. This prospective study includes systematic collection and grading of acute and late radiation-related toxicity outcomes in order to evaluate the safety of the implemented protocol and to assess whether toxicity rates are comparable to those reported in published clinical studies. The results will support optimization and quality assurance of the radiotherapy technique in routine clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with breast cancer after breast-conserving surgery receive adjuvant radiotherapy with a simultaneous integrated boost (SIB) to the tumor bed. Acute and late toxicity outcomes are prospectively recorded.
| Arm | Type | Receives |
|---|---|---|
| Adjuvant Radiotherapy With Simultaneous Integrated Boost (SIB) | Experimental | Radiation: Adjuvant Breast Radiotherapy With Simultaneous Integrated Boost (SIB)Breast cancer patients treated with breast-conserving surgery receive adjuvant radiotherapy to the whole breast with a simultaneous integrated boost (SIB) to the tumor bed, using either standard fractionation or hypofractionation. Acute and late toxicity outcomes are prospectively recorded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female patients with histologically confirmed breast cancer
- Status post breast-conserving surgery (lumpectomy)
- Planned adjuvant whole-breast radiotherapy with simultaneous integrated boost (SIB) to the tumor bed
- Age ≥ 18 years
- Ability to provide informed consent
Key exclusion criteria (4 listed)
- Prior radiotherapy to the breast or thoracic region
- Mastectomy (no breast-conserving surgery)
- Pregnancy or breastfeeding
- Inability to complete planned radiotherapy or follow-up assessments
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 |
|---|---|---|
| Adjuvant Breast Radiotherapy With Simultaneous Integrated Boost (SIB)Adjuvant whole-breast radiotherapy after breast-conserving surgery with a simultaneous integrated boost (SIB) dose delivered to the tumor bed during the same treatment sessions. Treatment is delivered using either standard fractionation or hypofractionation, according to institutional protocol. | Radiation | Adjuvant Radiotherapy With Simultaneous Integrated Boost (SIB) |
Primary outcome
Acute Radiation Toxicity (CTCAE)
Time frame: From start of radiotherapy up to 3 months after completion of radiotherapy
Incidence and severity of acute radiotherapy-related toxicity assessed during treatment and shortly after completion, graded according to Common Terminology Criteria for Adverse Events (CTCAE).
Acute Radiation Toxicity (CTCAE)
Time frame: From start of radiotherapy up to 3 months after completion of radiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adjuvant Breast Radiotherapy With Simultaneous Integrated Boost (SIB) in people with Breast Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
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 5 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: finished, as of the sponsor's last update on 17 Feb 2026. 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 Slovenia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Radiation Toxicity (CTCAE) (time frame: From start of radiotherapy up to 3 months after completion of radiotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2026.