Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05914831

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Breast Cancer Female

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Acute toxicity

    Time frame: 1-6 months after RT

    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

  2. Late toxicity

    Time frame: 6-60 months after RT

    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

Secondary outcomes

  1. Local-regional control

    Time frame: 3, 5 and 10 years

    Any newly suspicious skin change/s or palpable lymph node in the irradiated area that is/are pathologically proved to be locoregional tumor recurrence.

  2. Disease-free survival

    Time frame: 3, 5 and 10 years

    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. Overall Survival

    Time frame: 3, 5 and 10 years

    Time from adjuvant radiotherapy to death.

  4. Distant metastasis occurrence

    Time frame: 3, 5 and 10 years

    The time from adjuvant radiotherapy to the occurrence of distant metastasis.

  5. Cosmetic outcome

    Time frame: 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.

    The Harvard score for breast cosmesis (a 4-grade scale) will be used, which will be independently filled out by both patients and physicians.

  6. QoL assessment

    Time frame: 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.

    We will use the EORTC QLQ-BR23 questionnaire validated for the Serbian-speaking population to assess the quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Marko Bojovic

CONTACT

[email protected]

Olivera Ivanov

CONTACT

[email protected]

0214805496

Sponsors and collaborators

Lead sponsor

Oncology Institute of Vojvodina

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2033
First posted
Jun 22, 2023
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.