Ultra-hypofractionated Irradiation of the Whole Breast (WBI) Compared to Partial Breast Irradiation (PBI)

NCT05914831 | Active Not Recruiting Phase 2 DMC FDA Device

• 1 other identifier: NS-dojka-SRB
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

Female patients undergoing surgical treatment for early breast cancer and meeting the inclusion criteria for adjuvant breast radiotherapy were randomized into two groups. One group will receive adjuvant whole-breast radiotherapy in ultra-hypofractionated regimen of 26 Gy in 5 fractions. In contrast, the other group will receive partial breast irradiation with a dose of 26Gy in 5 fractions. The study's objective is to compare the effects of both breast radiotherapy protocols in terms of locoregional disease control and survival and to compare the adverse effects of radiotherapy between the two protocols. To determine if there is a correlation between different parameters and the efficacy and degree of toxicity for both protocols.

Conditions

Breast Cancer Female

Keywords

Ultra-hypofractionated radiotherapy; Partial breast irradiation; Breast radiotherapy toxicity

Outcome Measures

Primary Outcomes (2)

• Acute Radiation Toxicity

  Proportion of participants experiencing acute radiation toxicity, defined as toxicity occurring within 6 months of the start of radiotherapy, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Toxicity types assessed include gastrointestinal, genitourinary, and skin toxicity.

  From the start of radiotherapy up to 6 months.

• Late Radiation Toxicity

  Proportion of participants experiencing late radiation toxicity, defined as toxicity occurring more than 6 months after the start of radiotherapy, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Toxicity types assessed include gastrointestinal, genitourinary, and skin toxicity.

  From 6 months after the start of radiotherapy up to 60 months.

Secondary Outcomes (8)

• Time to Local-Regional Recurrence

  From adjuvant radiotherapy until locoregional recurrence, assessed up to 10 years.

• Disease-Free Survival (DFS)

  From adjuvant radiotherapy until disease recurrence, second primary tumor, or death from any cause, assessed up to 10 years.

• Overall Survival (OS)

  From adjuvant radiotherapy until death from any cause, assessed up to 10 years.

• Time to Distant Metastasis

  From adjuvant radiotherapy until distant metastasis or death, assessed up to 10 years.

• Physician-reported Harvard Breast Cosmesis Scale

  Baseline; 1 month after the end of treatment; every 3 months for the first 2 years; every 6 months in years 4 and 5; and annually after year 5.

Study Arms (2)

Partial Breast Irradiation

ACTIVE COMPARATOR

Radiation: Partial Breast Irradiation

Whole Breast Irradiation

EXPERIMENTAL

Radiation: Ultra-hypofractionated WBI

Interventions

Ultra-hypofractionated WBI RADIATION

An ultra-short course of radiotherapy with 26Gy in 5 fractions will be administered to the whole breast where the tumor was located.

Whole Breast Irradiation

Partial Breast Irradiation RADIATION

The course of radiotherapy with 26Gy in 5 fractions will be administered to the part of the breast where the tumor was located.

Partial Breast Irradiation

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast-conserving surgery
• Invasive ductal carcinoma
• Age ≥ 50
• Tumor size ≤ 3 cm
• R0 resection
• Unicentric/unifocal carcinoma or multifocal carcinoma within 2 cm of the primary neoplasm
• pN0 (sentinel lymph node biopsy or axillary lymph node dissection performed), N1mi
• Hormone receptor status - any
• Histological grade G1 or G2

You may not qualify if:

• Neoadjuvant systemic therapy
• TNBC (triple-negative breast cancer)
• Extensive intraductal component (EIC)
• Lymphovascular invasion (LVI)
• associated DCIS \> 2.5 cm in size or high nuclear grade

Sponsors & Collaborators

• Oncology Institute of Vojvodina: lead

Study Sites (1)

Oncology Institute of Vojvodina

Novi Sad, Vojvodina, 21204, Serbia

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 22, 2023
• Study Start: June 1, 2023
• Primary Completion: June 1, 2026
• Study Completion (Estimated): June 1, 2036
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The expected time for the publication of the first data is in 3 years (2026).
• Access Criteria: Contact the researchers via email.

Locations

SE (1)