Breast Cancer FemalePhase 2NCT05914831
Ultra-hypofractionated Irradiation of the Whole Breast (WBI) Compared to Partial Breast Irradiation (PBI)
A Phase 2 study testing Ultra-hypofractionated WBI and Partial Breast Irradiation in people with Breast Cancer Female, run by Oncology Institute of Vojvodina at 1 site in Serbia.
Trial summary
Female patients undergoing surgical treatment for early breast cancer and meeting the inclusion criteria for adjuvant breast radiotherapy were randomized into two groups. One group will receive adjuvant whole-breast radiotherapy in ultra-hypofractionated regimen of 26 Gy in 5 fractions. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Ultra-hypofractionated WBI and Partial Breast Irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteSerbia
- Study dates
- 1 Jun 2023to 1 Jun 2036
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast-conserving surgery
- Invasive ductal carcinoma
- Age ≥ 50
- Tumor size ≤ 3 cm
- R0 resection
- Unicentric/unifocal carcinoma or multifocal carcinoma within 2 cm of the primary neoplasm
Show all 9Show fewer
- pN0 (sentinel lymph node biopsy or axillary lymph node dissection performed), N1mi
- Hormone receptor status - any
- Histological grade G1 or G2
Who cannot join
- Neoadjuvant systemic therapy
- TNBC (triple-negative breast cancer)
- Extensive intraductal component (EIC)
- Lymphovascular invasion (LVI)
- associated DCIS > 2.5 cm in size or high nuclear grade
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultra-hypofractionated Radiotherapy for Whole Breast Irradiation (WBI) Compared to Partial Breast Irradiation (PBI): A Single-Institution Prospective Phase 2 Trial
Female patients undergoing surgical treatment for early breast cancer and meeting the inclusion criteria for adjuvant breast radiotherapy were randomized into two groups. One group will receive adjuvant whole-breast radiotherapy in ultra-hypofractionated regimen of 26 Gy in 5 fractions. In contrast, the other group will receive partial breast irradiation with a dose of 26Gy in 5 fractions.
The study's objective is to compare the effects of both breast radiotherapy protocols in terms of locoregional disease control and survival and to compare the adverse effects of radiotherapy between the two protocols. To determine if there is a correlation between different parameters and the efficacy and degree of toxicity for both protocols.
Read the detailed description
Radiation therapy should ideally start 6-8 weeks after breast-conserving surgery but no later than 12 weeks after the surgery.
If adjuvant chemotherapy has been administered, it is recommended to start radiation therapy three weeks after chemotherapy (optionally, it can be completed before beginning chemotherapy).
The radiation therapy procedure follows the existing clinical protocol for breast radiotherapy. For radiation therapy planning, the patient is positioned supine using immobilization devices (such as a wing board or similar) to ensure daily reproducibility within a range of 5 mm. The clinical target volume (CTV) is delineated according to the recommendations of the Danish Breast Cancer Cooperative Group (DBCG) and the European Society for Radiotherapy and Oncology (ESTRO).
A total dose of 26Gy in 5 fractions every working day using the Volumetric Modulated Arc Therapy (VMAT) technique. Daily portal images are obtained, and a breathing control protocol is applied based on clinical assessment.
- Conditions
- Breast Cancer Female
- Being tested
- Ultra-hypofractionated WBI, Partial Breast Irradiation
- Keywords
- Ultra-hypofractionated radiotherapy, Partial breast irradiation, Breast radiotherapy toxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra-hypofractionated WBIRadiation
An ultra-short course of radiotherapy with 26Gy in 5 fractions will be administered to the whole breast where the tumor was located.
Partial Breast IrradiationRadiation
The course of radiotherapy with 26Gy in 5 fractions will be administered to the part of the breast where the tumor was located.
| Study group | Role | What they receive |
|---|---|---|
| Partial Breast Irradiation | Active comparator | Not described Receives: Radiation: Partial Breast Irradiation |
| Whole Breast Irradiation | Experimental | Not described Receives: Radiation: Ultra-hypofractionated WBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Radiation Toxicity
Proportion of participants experiencing acute radiation toxicity, defined as toxicity occurring within 6 months of the start of radiotherapy, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Toxicity types assessed include gastrointestinal, genitourinary, and skin toxicity.
Measured: From the start of radiotherapy up to 6 months.
Late Radiation Toxicity
Proportion of participants experiencing late radiation toxicity, defined as toxicity occurring more than 6 months after the start of radiotherapy, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Toxicity types assessed include gastrointestinal, genitourinary, and skin toxicity.
Measured: From 6 months after the start of radiotherapy up to 60 months.
Secondary outcomes (8)
Time to Local-Regional Recurrence
Time from adjuvant radiotherapy to the first occurrence of pathologically confirmed locoregional tumor recurrence, defined as any newly suspicious skin change(s) or palpable lymph node(s) in the irradiated area. Participants without locoregional recurrence are censored at the date of last follow-up.
Measured: From adjuvant radiotherapy until locoregional recurrence, assessed up to 10 years.
Disease-Free Survival (DFS)
Time from adjuvant radiotherapy to the first occurrence of clinically confirmed local recurrence, distant metastasis, second primary tumor, or death from any cause, whichever occurs first. Participants who are alive and disease-free at the time of analysis are censored at the date of last follow-up.
Measured: From adjuvant radiotherapy until disease recurrence, second primary tumor, or death from any cause, assessed up to 10 years.
Overall Survival (OS)
Time from adjuvant radiotherapy to death from any cause. Participants who are alive at the time of analysis are censored at the date of last follow-up.
Measured: From adjuvant radiotherapy until death from any cause, assessed up to 10 years.
Time to Distant Metastasis
Time from adjuvant radiotherapy to the first occurrence of distant metastasis, confirmed by imaging or pathology. Participants without distant metastasis are censored at the date of last follow-up or death.
Measured: From adjuvant radiotherapy until distant metastasis or death, assessed up to 10 years.
Physician-reported Harvard Breast Cosmesis Scale
Cosmesis assessed by the physician using the Harvard Breast Cosmesis Scale. This is a 4-point categorical scale: Excellent (treated breast nearly identical to the untreated breast), Good (slight difference between breasts), Fair (obvious difference between breasts but without major distortion), and Poor (marked distortion of the treated breast). Higher scores (Poor) indicate worse cosmesis. The physician completes the assessment independently.
Measured: Baseline; 1 month after the end of treatment; every 3 months for the first 2 years; every 6 months in years 4 and 5; and annually after year 5.
Patient-reported Harvard Breast Cosmesis Scale
Cosmesis assessed by the patient using the Harvard Breast Cosmesis Scale. This is a 4-point categorical scale: Excellent (treated breast nearly identical to the untreated breast), Good (slight difference between breasts), Fair (obvious difference between breasts but without major distortion), and Poor (marked distortion of the treated breast). Higher scores (Poor) indicate worse cosmesis. The patient completes the assessment independently.
Measured: Baseline; 1 month after the end of treatment; every 3 months for the first 2 years; every 6 months in years 4 and 5; and annually after year 5.
Quality of Life - EORTC QLQ-C30 (Serbian version)
The Serbian translation of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), validated for the Serbian-speaking population, will be used to assess quality of life. This questionnaire consists of 30 items grouped into functional scales, symptom scales, a global health status/QoL scale, and single-item symptom scales. Responses are converted to a 0 to 100 scale. For functional and global QoL scales, higher scores indicate better functioning/QoL. For symptom scales, higher scores indicate greater symptom severity.
Measured: Baseline; 1 month after the end of treatment; every 3 months for the first 2 years; every 6 months in years 4 and 5; and annually after year 5.
Quality of Life - EORTC QLQ-BR23 (Serbian version)
The Serbian translation of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer Module (EORTC QLQ-BR23), validated for the Serbian-speaking population, will be used to assess breast cancer-specific quality of life. This 23-item module includes functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and symptom scales (systemic therapy side effects, breast symptoms, arm symptoms, upset by hair loss). Scores are converted to a 0 to 100 scale. For functional scales, higher scores indicate better functioning. For symptom scales, higher scores indicate greater symptom severity.
Measured: Baseline; 1 month after the end of treatment; every 3 months for the first 2 years; every 6 months in years 4 and 5; and annually after year 5.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Jun 2023
- Primary completion1 Jun 2026
- Study completion1 Jun 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oncology Institute of Vojvodina
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marko Bojovic, Oncology Institute of Vojvodina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914831
- Sponsor's protocol ID
- NS-dojka-SRB
- Status last verified
- Sep 2026
- First submitted
- 8 Jun 2023
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The analyzed data from the study will be published in scientific journals. We are prepared to share our data for analysis with researchers from similar studies (previously registered on ClinicalTrials.gov) to compare our results.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-hypofractionated Radiotherapy for Whole Breast Irradiation (WBI) Compared to Partial Breast Irradiation (PBI): A Single-Institution Prospective Phase 2 Trial
- ClinicalTrials.gov ID
- NCT05914831
- Acronym / sponsor ID
- NS-dojka-SRB
- Conditions
- Breast Cancer Female
- Keywords
- Ultra-hypofractionated radiotherapy, Partial breast irradiation, Breast radiotherapy toxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Oncology Institute of VojvodinaOther government
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2036 (estimated)
- First posted
- 22 Jun 2023 (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.
Female patients undergoing surgical treatment for early breast cancer and meeting the inclusion criteria for adjuvant breast radiotherapy were randomized into two groups. One group will receive adjuvant whole-breast radiotherapy in ultra-hypofractionated regimen of 26 Gy in 5 fractions. In contrast, the other group will receive partial breast irradiation with a dose of 26Gy in 5 fractions.
The study's objective is to compare the effects of both breast radiotherapy protocols in terms of locoregional disease control and survival and to compare the adverse effects of radiotherapy between the two protocols. To determine if there is a correlation between different parameters and the efficacy and degree of toxicity for both protocols.
Detailed description
Radiation therapy should ideally start 6-8 weeks after breast-conserving surgery but no later than 12 weeks after the surgery.
If adjuvant chemotherapy has been administered, it is recommended to start radiation therapy three weeks after chemotherapy (optionally, it can be completed before beginning chemotherapy).
The radiation therapy procedure follows the existing clinical protocol for breast radiotherapy. For radiation therapy planning, the patient is positioned supine using immobilization devices (such as a wing board or similar) to ensure daily reproducibility within a range of 5 mm. The clinical target volume (CTV) is delineated according to the recommendations of the Danish Breast Cancer Cooperative Group (DBCG) and the European Society for Radiotherapy and Oncology (ESTRO).
A total dose of 26Gy in 5 fractions every working day using the Volumetric Modulated Arc Therapy (VMAT) technique. Daily portal images are obtained, and a breathing control protocol is applied based on clinical assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partial Breast Irradiation | Active comparator | Radiation: Partial Breast Irradiation |
| Whole Breast Irradiation | Experimental | Radiation: Ultra-hypofractionated WBI |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Breast-conserving surgery
- Invasive ductal carcinoma
- Age ≥ 50
- Tumor size ≤ 3 cm
- R0 resection
Key exclusion criteria (5 listed)
- Neoadjuvant systemic therapy
- TNBC (triple-negative breast cancer)
- Extensive intraductal component (EIC)
- Lymphovascular invasion (LVI)
- associated DCIS > 2.5 cm in size or high nuclear grade
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 |
|---|---|---|
| Ultra-hypofractionated WBIAn ultra-short course of radiotherapy with 26Gy in 5 fractions will be administered to the whole breast where the tumor was located. | Radiation | Whole Breast Irradiation |
| Partial Breast IrradiationThe course of radiotherapy with 26Gy in 5 fractions will be administered to the part of the breast where the tumor was located. | Radiation | Partial Breast Irradiation |
Primary outcome
Acute Radiation Toxicity
Time frame: From the start of radiotherapy up to 6 months.
Proportion of participants experiencing acute radiation toxicity, defined as toxicity occurring within 6 months of the start of radiotherapy, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Toxicity types assessed include gastrointestinal, genitourinary, and skin toxicity.
Late Radiation Toxicity
Time frame: From 6 months after the start of radiotherapy up to 60 months.
Proportion of participants experiencing late radiation toxicity, defined as toxicity occurring more than 6 months after the start of radiotherapy, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Toxicity types assessed include gastrointestinal, genitourinary, and skin toxicity.
8 secondary outcomes
Time to Local-Regional Recurrence
Time frame: From adjuvant radiotherapy until locoregional recurrence, assessed up to 10 years.
Disease-Free Survival (DFS)
Time frame: From adjuvant radiotherapy until disease recurrence, second primary tumor, or death from any cause, assessed up to 10 years.
Overall Survival (OS)
Time frame: From adjuvant radiotherapy until death from any cause, assessed up to 10 years.
Time to Distant Metastasis
Time frame: From adjuvant radiotherapy until distant metastasis or death, assessed up to 10 years.
Physician-reported Harvard Breast Cosmesis Scale
Time frame: Baseline; 1 month after the end of treatment; every 3 months for the first 2 years; every 6 months in years 4 and 5; and annually after year 5.
Patient-reported Harvard Breast Cosmesis Scale
Time frame: Baseline; 1 month after the end of treatment; every 3 months for the first 2 years; every 6 months in years 4 and 5; and annually after year 5.
Quality of Life - EORTC QLQ-C30 (Serbian version)
Time frame: Baseline; 1 month after the end of treatment; every 3 months for the first 2 years; every 6 months in years 4 and 5; and annually after year 5.
Quality of Life - EORTC QLQ-BR23 (Serbian version)
Time frame: Baseline; 1 month after the end of treatment; every 3 months for the first 2 years; every 6 months in years 4 and 5; and annually after year 5.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Yes. The analyzed data from the study will be published in scientific journals. We are prepared to share our data for analysis with researchers from similar studies (previously registered on ClinicalTrials.gov) to compare our results.
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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 Phase 2 study testing Ultra-hypofractionated WBI and Partial Breast Irradiation in people with Breast Cancer Female, run by Oncology Institute of Vojvodina at 1 site in Serbia.
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 9 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. 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 Serbia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 Radiation Toxicity (time frame: From the start of radiotherapy up to 6 months.). The study lists 2 primary outcomes in all. 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 29 Sep 2026.