Adjuvant Ultra-Hypofractionated vs Hypofractionated Radiotherapy for Early Breast Cancer

NCT07274800 | Completed DMC

• 1 other identifier: 11119
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Acute Skin Toxicity (CTCAE v5.0)

  Incidence and severity of acute skin toxicity (erythema, desquamation, edema) assessed

  From start of radiotherapy to 6 weeks post-treatment

Secondary Outcomes (2)

• Late Skin Toxicity and Cosmesis

  12 months post-radiotherapy

• Locoregional Recurrence

  Up to 24 months post-radiotherapy

Study Arms (2)

Arm A:Adjuvat Ultra-Hypofractionation Radiotherapy

EXPERIMENTAL

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

Arm B: Adjuvant hypofractionation radiotherapy

EXPERIMENTAL

Radiation: Adjuvant Hypofarctionated radiotherapy

Interventions

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

Arm A:Adjuvat Ultra-Hypofractionation Radiotherapy

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

Arm B: Adjuvant hypofractionation radiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University

Zagazig, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 10, 2025
• Study Start: November 27, 2023
• Primary Completion: November 27, 2025
• Study Completion: November 27, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-11

Locations

EG (1)