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

NCT05914831 | Recruiting Phase 2 DMC FDA Device

• 1 other identifier: NS-dojka-SRB
• Study Type: interventional
• Target: 100
• 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 toxicity

  Assessment of acute toxicity of radiotherapy in two radiotherapy regimens. Acute toxicity will be scored according to the Common Terminology Criteria for Adverse Events (CTCAE) scale version 5.0

  1-6 months after RT

• Late toxicity

  Assessment of late toxicity of radiotherapy in two radiotherapy regimens. Acute toxicity will be scored according to the Common Terminology Criteria for Adverse Events (CTCAE) scale version 5.0

  6-60 months after RT

Secondary Outcomes (6)

• Local-regional control

  3, 5 and 10 years

• Disease-free survival

  3, 5 and 10 years

• Overall Survival

  3, 5 and 10 years

• Distant metastasis occurrence

  3, 5 and 10 years

• Cosmetic outcome

  at baseline, during the radiotherapy, immediately after radiotherapy termination and then in the first 2 years every 3 months, in the 4th and 5th year every 6 months and after 5 years once per year.

Study Arms (2)

Partial Breast Irradiation

ACTIVE COMPARATOR

Radiation: Ultra-fractionated PBI

Whole Breast Irradiation

EXPERIMENTAL

Radiation: Ultra-fractionated WBI

Interventions

Ultra-fractionated 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

Ultra-fractionated PBI RADIATION

An ultra-short 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

RECRUITING

Central Study Contacts

Olivera Ivanov

CONTACT

0214805496; ivanov.olivera@onk.ns.ac.rs

Marko Bojovic

CONTACT

bojovic.marko@onk.ns.ac.rs

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: Ass. MD

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 22, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2033
• Last Updated: July 3, 2023

Record last verified: 2023-06

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)