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Completed

NCT Number: NCT07274800

Adjuvant Ultra-Hypofractionated vs Hypofractionated Radiotherapy for Early 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zagazig University

Zagazig, Egypt

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

Adjuvant Ultra hypofractionation radiotherapy

Radiation

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

Adjuvant Hypofarctionated radiotherapy

Radiation

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Acronym: UHF vs HF-EBC

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 10, 2025
Registry last updated
Dec 10, 2025

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.

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