Toxicity Outcomes of Simultaneous Integrated Boost in Adjuvant Breast Radiotherapy Acronym

Toxicity Outcomes of Simultaneous Integrated Boost as Part of Adjuvant Radiotherapy in Breast Cancer Patients After Breast-Conserving Surgery

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07407192

Acronym

SIB

Enrollment

Registered

2026-02-12

Start date

2019-01-01

Completion date

2024-12-31

Last updated

2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast Cancer

Brief 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. 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.

Interventions

RADIATIONAdjuvant 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention 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.

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Acute Radiation Toxicity (CTCAE)	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).

Countries

Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026