Toxicity Outcomes of Simultaneous Integrated Boost in Adjuvant Breast Radiotherapy Acronym

NCT07407192 | Completed

• 2 other identifiers: OI-BREAST-SIB-2019ERIDEK-0045/2019
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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).

  From start of radiotherapy up to 3 months after completion of radiotherapy

• Acute Radiation Toxicity (CTCAE)

  From start of radiotherapy up to 3 months after completion of radiotherapy

Study Arms (1)

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.

Radiation: Adjuvant Breast Radiotherapy With Simultaneous Integrated Boost (SIB)

Interventions

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.

Adjuvant Radiotherapy With Simultaneous Integrated Boost (SIB)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 12, 2026
• Study Start: January 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2024
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)