Breast CancerUHF vs HF-EBCNCT07274800
Adjuvant Ultra-Hypofractionated vs Hypofractionated Radiotherapy for Early Breast Cancer
A study testing Adjuvant Ultra hypofractionation radiotherapy and Adjuvant Hypofarctionated radiotherapy in people with Breast Cancer, run by Zagazig University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Adjuvant Ultra hypofractionation radiotherapy and Adjuvant Hypofarctionated radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Nov 2023to 27 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Locally advanced disease pT4, N2,3.
- Positive surgical margins
- Prior thoracic radiation
- Synchronous second primary tumor
- Distant metastases
- Pregnancy
Show all 9Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Being tested
- Adjuvant Ultra hypofractionation radiotherapy, Adjuvant Hypofarctionated radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant Ultra hypofractionation radiotherapyRadiation
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 radiotherapyRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Radiation: Adjuvant Ultra hypofractionation radiotherapy |
| Arm B: Adjuvant hypofractionation radiotherapy | Experimental | Not described Receives: Radiation: Adjuvant Hypofarctionated radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Skin Toxicity (CTCAE v5.0)
Incidence and severity of acute skin toxicity (erythema, desquamation, edema) assessed
Measured: From start of radiotherapy to 6 weeks post-treatment
Secondary outcomes (2)
Late Skin Toxicity and Cosmesis
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)
Measured: 12 months post-radiotherapy
Locoregional Recurrence
Rate of locoregional recurrence in the irradiated breast assessed by clinical examination and imaging at follow-up visits
Measured: Up to 24 months post-radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start27 Nov 2023
- Primary completion27 Nov 2025
- Study completion27 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07274800
- Sponsor's protocol ID
- 11119
- Acronym
- UHF vs HF-EBC
- Status last verified
- Nov 2025
- First submitted
- 28 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Ultra Hypofractionation Radiotherapy Versus Hypofractionation Radiotherapy in Treatment of Early Invasive Breast Cancer
- ClinicalTrials.gov ID
- NCT07274800
- Acronym / sponsor ID
- UHF vs HF-EBC / 11119
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 27 Nov 2025 (actual)
- Study completion
- 27 Nov 2025 (actual)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A:Adjuvat Ultra-Hypofractionation Radiotherapy | Experimental | Radiation: Adjuvant Ultra hypofractionation radiotherapyAdjuvant 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 B: Adjuvant hypofractionation radiotherapy | Experimental | Radiation: Adjuvant Hypofarctionated radiotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Locally advanced disease pT4, N2,3.
- Positive surgical margins
- Prior thoracic radiation
- Synchronous second primary tumor
- Distant metastases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adjuvant Ultra hypofractionation radiotherapyAdjuvant 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 | Arm A:Adjuvat Ultra-Hypofractionation Radiotherapy |
| Adjuvant Hypofarctionated radiotherapyAdjuvant 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 | Radiation | Arm B: Adjuvant hypofractionation radiotherapy |
Primary outcome
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
2 secondary outcomes
Late Skin Toxicity and Cosmesis
Time frame: 12 months post-radiotherapy
Locoregional Recurrence
Time frame: Up to 24 months post-radiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adjuvant Ultra hypofractionation radiotherapy and Adjuvant Hypofarctionated radiotherapy in people with Breast Cancer, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Skin Toxicity (CTCAE v5.0) (time frame: From start of radiotherapy to 6 weeks post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.