Prospective Comparative Study of Hypofractionated Adjuvant Radiotherapy in 2 Virsus 3 Weeks in Breast Cancer

January 8, 2026 updated by: Salwa Shawky Bakeet Ali

To compare the efficacy and safety of two hypofractionated adjuvant radiotherapy regimens 34 Gy in 10

fractions versus 40.05 Gy in 15 fractions in patients with breast cancer treated at the South Egypt Cancer

Institute.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Female breast cancer (BC) has been the leading cause of cancer morbidity and mortality among women in the

majority of countries for decades. In 2020, there were an estimated 2.3 million new cases and 685,000 deaths

from female BC worldwide, which accounted for one in four cancer cases and one in six cancer deaths among

women.

u For women with newly diagnosed, non-metastatic breast cancer, treatment consists of a multidisciplinary

approach that involves input from surgery, radiation oncology, and medical oncology. The objective of adjuvant

radiation therapy (RT) is to eradicate any tumor deposits remaining following surgery for patients treated by

either breast-conserving surgery or mastectomy . Doing so reduces risk of locoregional recurrence and improves

breast cancer-specific and overall survivals.

u A historical regimen of 25-28 fractions over 6 weeks was adopted for radiotherapy (RT) following breast-

conserving surgery (BCS) and total mastectomy. An early assumption that breast cancer cell lines might be more

sensitive to fractional doses than acute skin reactions and other squamous carcinomas lead to development of the

hypofractionated RT (HypoRT) approach, which elevated fractional dose up to 3 Gy with reduced total

dose/fractions, for obtaining radiobiological equivalence to a traditional regimen of 50-50.4 Gy in 25-28

fractions.

u Recently, the American Society of Radiation Oncology released a task force guideline recommending

hypofractionated radiotherapy for all women of any age whether they had received chemotherapy or not ,Their

evidence-based recommendations were supported by studies from Canada and the United Kingdom.

u Benefits of HypoRT include both, radiobiologic advantages and reduced length of treatment courses, for

improving healthcare resources and patient convenience. Consequently, HypoRT has been widely adopted

worldwide based on a series of randomized clinical trials .

u Recently, HypoRT over 3 weeks and with shorter courses of 5 fractions have been recommended in treatment

guidelines.

u Regarding clinical outcomes of a 2-week fractionation schedule , it was observed that acute and late effects were

acceptable with control rates similar to those reported in other trials with hypofractionation,Based

on these findings we started a trial to compare a 3-week radiotherapy schedule with a 2-week schedule .

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Asyut, Egypt
        • Assuit

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

Sampling Method

Non-Probability Sample

Study Population

breast cancer patients above 18y,with invasive carcinoma,excision of primary,recieved neoadjuvant or adj cth .

Description

Inclusion Criteria:

  • Female patients aged ≥18 years.

Female or male patients with invasive carcinoma of the breast.

Complete microscopic excision of primary tumor.

Undergoing breast-conserving surgery (BCS) or modified radical mastectomy (MRM).

≥ Axillary lymph nodes dissected.

T1_4pN0_3M0 disease.

Neoadjuvant or adjuvant CTH .

Signed informed consent and able to comply with follow up.

Exclusion Criteria:

  • Evidence of distant metastases.

Past history of malignancy.

Prior radiotherapy to the chest region

Simultaneous malignancy (except non-melanoma skin cancer or in situ cervical carcinoma)

Connective tissue diseases (e.g., lupus erythematosus, scleroderma)

Pregnancy or lactation

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
hypofractionated adjuvant radiotherapy regimens 40.05 Gy in 15 fractions in breast cancer in 3w
Device: radiotherapy
Hypofractionated Adjuvant Radiotherapy in 2 versus 3 Weeks of Breast Cancer and effect skin toxicity and over all survival
B

hypofractionated adjuvant radiotherapy regimens 34 Gy in 10

fractions in 2w
Device: radiotherapy
Hypofractionated Adjuvant Radiotherapy in 2 versus 3 Weeks of Breast Cancer and effect skin toxicity and over all survival

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival analyzed from the date of diagnosis.
Time Frame: through study completion, an average of 1 year
local control was defined as absence of disease in the irradiated areas.recurrence were categorized as local(breast or surgical bed), regional(lymphatic drainage of axillary, supraclavicular fossa or internal mammary chain),or distant (metastasis),and any associayion of these
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Acute Skin Toxicity
Time Frame: From start of radiotherapy through 3 months after completion of radiotherapy
Acute toxicities will be assessed according to RTOG criteria. The most severe toxicity presented will be reported.
From start of radiotherapy through 3 months after completion of radiotherapy
Assessment of Late Skin Toxicity
Time Frame: From 3 months after completion of radiotherapy through study completion, an average of 1 year
Late toxicities will be assessed according to RTOG criteria. The most severe toxicity presented will be reported.
From 3 months after completion of radiotherapy through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Salwa Shawky Bakeet Ali

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

January 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

September 25, 2025

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • adjuvant radiotherapy in BC

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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