Adjuvant Ultra-Hypofractionated vs Hypofractionated Radiotherapy for Early Breast Cancer (UHF vs HF-EBC)

November 28, 2025 updated by: Zagazig University

Adjuvant Ultra Hypofractionation Radiotherapy Versus Hypofractionation Radiotherapy in Treatment of Early Invasive Breast Cancer

breast-conserving surgery. One group receives ultra-hypofractionated radiotherapy (26 Gy in 5 sessions over 1 week), while the other group receives hypofractionated radiotherapy (40 Gy in 15 sessions over 3 weeks). The study aims to compare skin toxicity, cosmetic outcomes, and local cancer control between thetwo schedules . Participants are followed during and after radiotherapy for up to 24 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Zagazig, Egypt
        • Zagazig University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:• Histological diagnosis of breast adenocarcinoma

  • Prior breast conservative surgery negative resection margins (3 mm)
  • Pathological stage pT1-pT2, N0-1, pT3-N0, M0
  • No macroscopic evidence of distant metastases at diagnosis
  • Age 18-80 years
  • Female patients
  • Normal hematological and biochemical laboratory tests
  • Written informed consent was obtained from all patients

Exclusion Criteria: • Patients underwent mastectomy.

  • Locally advanced disease pT4, N2,3.
  • Positive surgical margins
  • Prior thoracic radiation
  • Synchronous second primary tumor
  • Distant metastases
  • Pregnancy
  • Presence of a concomitant psychiatric disorder precluding an aware informed consent.
  • Age >80 years
  • Low risk patient meeting all the following criteria (more than or equal 65 years, PT1, grade 1 or 2, +ER, -Her2nu, N0, M0).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A:Adjuvat Ultra-Hypofractionation Radiotherapy
Adjuvant external beam radiotherapy after breast-conserving surgery Total dose: 26 Gy delivered in 5 fractions over 1 week 3D conformal radiotherapy technique without breath-hold Daily fractionation, whole breast irradiation
Radiation: Adjuvant Ultra hypofractionation radiotherapy
Adjuvant external beam radiotherapy after breast-conserving surgery Total dose: 26 Gy delivered in 5 fractions over 1 week 3D conformal radiotherapy technique without breath-hold Daily fractionation, whole breast irradiation
Experimental: Arm B: Adjuvant hypofractionation radiotherapy
Radiation: Adjuvant Hypofarctionated radiotherapy
Adjuvant external beam radiotherapy after breast-conserving surgery Total dose: 40 Gy delivered in 15 fractions over 3 week 3D conformal radiotherapy technique without breath-hold Daily fractionation, whole breast irradiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Skin Toxicity (CTCAE v5.0)
Time Frame: From start of radiotherapy to 6 weeks post-treatment
Incidence and severity of acute skin toxicity (erythema, desquamation, edema) assessed
From start of radiotherapy to 6 weeks post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Late Skin Toxicity and Cosmesis
Time Frame: 12 months post-radiotherapy
Incidence of late skin changes (pigmentation, fibrosis) and cosmetic outcomes assessed at 12 months post-radiotherapy using physician assessment and patient-reported outcomes (EORTC QLQ)
12 months post-radiotherapy
Locoregional Recurrence
Time Frame: Up to 24 months post-radiotherapy
Rate of locoregional recurrence in the irradiated breast assessed by clinical examination and imaging at follow-up visits
Up to 24 months post-radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2023

Primary Completion (Actual)

November 27, 2025

Study Completion (Actual)

November 27, 2025

Study Registration Dates

First Submitted

November 28, 2025

First Submitted That Met QC Criteria

November 28, 2025

First Posted (Actual)

December 10, 2025

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

November 28, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11119 (DAIDS ES Registry Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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