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

Ultra-hypofractionated for Whole Breast Irradiation (WBI) Compared to Partial Breast Irradiation (PBI): A Single-Institution Prospective Phase 2 Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer Female
• Intervention / Treatment: Radiation: Ultra-fractionated PBI; Radiation: Ultra-fractionated WBI

Detailed Description

Radiation therapy should ideally start 6-8 weeks after breast-conserving surgery but no later than 12 weeks after the surgery.

If adjuvant chemotherapy has been administered, it is recommended to start radiation therapy three weeks after chemotherapy (optionally, it can be completed before beginning chemotherapy).

The radiation therapy procedure follows the existing clinical protocol for breast radiotherapy. For radiation therapy planning, the patient is positioned supine using immobilization devices (such as a wing board or similar) to ensure daily reproducibility within a range of 5 mm. The clinical target volume (CTV) is delineated according to the recommendations of the Danish Breast Cancer Cooperative Group (DBCG) and the European Society for Radiotherapy and Oncology (ESTRO).

A total dose of 26Gy in 5 fractions every working day using the Volumetric Modulated Arc Therapy (VMAT) technique. Daily portal images are obtained, and a breathing control protocol is applied based on clinical assessment (for left breast radiation therapy, active breath control is used - in deep inspiration or respiratory gating).

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Olivera Ivanov; Phone Number: 0214805496; Email: ivanov.olivera@onk.ns.ac.rs
• Study Contact Backup: Name: Marko Bojovic; Email: bojovic.marko@onk.ns.ac.rs

Study Locations

• Serbia
  • Vojvodina
    • Novi Sad, Vojvodina, Serbia, 21204
      • Recruiting
      • Oncology Institute of Vojvodina
      • Contact: Olivera Ivanov; Phone Number: 0214805496; Email: ivanov.olivera@onk.ns.ac.rs
      • Contact: Marko Bojovic; Email: bojovic.marko@onk.ns.ac.rs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Partial Breast Irradiation	Radiation: Ultra-fractionated PBI; 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.
Experimental: Whole Breast Irradiation	Radiation: Ultra-fractionated WBI; An ultra-short course of radiotherapy with 26Gy in 5 fractions will be administered to the whole breast where the tumor was located.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local-regional control	Any newly suspicious skin change/s or palpable lymph node in the irradiated area that is/are pathologically proved to be locoregional tumor recurrence.	3, 5 and 10 years
Disease-free survival	Disease-free survival refers to the time from adjuvant radiotherapy of breast cancer to clinically confirmed local recurrence, distant metastasis, second primary tumor diagnosis, or patient death.	3, 5 and 10 years
Overall Survival	Time from adjuvant radiotherapy to death.	3, 5 and 10 years
Distant metastasis occurrence	The time from adjuvant radiotherapy to the occurrence of distant metastasis.	3, 5 and 10 years
Cosmetic outcome	The Harvard score for breast cosmesis (a 4-grade scale) will be used, which will be independently filled out by both patients and physicians.	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.
QoL assessment	We will use the EORTC QLQ-BR23 questionnaire validated for the Serbian-speaking population to assess the quality of life.	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.

Collaborators and Investigators

• Sponsor: Oncology Institute of Vojvodina

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2033

Study Registration Dates

• First Submitted: June 8, 2023
• First Submitted That Met QC Criteria: June 19, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Partial breast irradiation; Ultra-hypofractionated radiotherapy; Breast radiotherapy toxicity
• Other Study ID Numbers: NS-dojka-SRB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The analyzed data from the study will be published in scientific journals. We are prepared to share our data for analysis with researchers from similar studies (previously registered on ClinicalTrials.gov) to compare our results.
• IPD Sharing Time Frame: The expected time for the publication of the first data is in 3 years (2026).
• IPD Sharing Access Criteria: Contact the researchers via email.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes