Breast CancerOMIT-RNINCT07724769
De-escalation of RNI in Breast Cancer Patients With pN0 After Neoadjuvant Therapy
A study testing Adjuvant Radiotherapy in people with Breast Cancer, run by Aya Ahmed Sayed.
Trial summary
Prospective Comparative Study of Response-Adapted De-escalation of Regional Nodal Irradiation in Initially Node Positive Breast Cancer Patients with Pathological Nodal Complete Response After Neoadjuvant Therapy Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Adjuvant Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Jun 2029
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients >= 18 years old.
- Histologically confirmed invasive breast cancer, cT1-3 N1M0 according to the 8th AJCC edition.
- Biopsy-proven cN1 disease at diagnosis.
- Completion of standard neoadjuvant systemic therapy.
- Surgical treatment of breast and axilla.
- Pathologically confirmed ypN0 status.
Show all 9Show fewer
- ECOG performance status 0-2.
- Suitable for adjuvant radiotherapy.
- Signed informed consent.
Who cannot join
- Metastatic disease (M1).
- Prior thoracic irradiation.
- Pregnancy or lactation.
- Severe uncontrolled comorbid illness.
- Any contraindication to radiotherapy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Comparative Study of Response-Adapted De-escalation of Regional Nodal Irradiation in Initially Node Positive Breast Cancer Patients With Pathological Nodal Complete Response After Neoadjuvant Therapy
Prospective Comparative Study of Response-Adapted De-escalation of Regional Nodal Irradiation in Initially Node Positive Breast Cancer Patients with Pathological Nodal Complete Response After Neoadjuvant Therapy
Read the detailed description
This prospective, randomized comparative study aims to evaluate the clinical outcomes and safety of response-adapted de-escalation of Regional Nodal Irradiation (RNI) in initially node-positive (cN1) breast cancer patients who achieved a pathological nodal complete response (pCR) following neoadjuvant systemic therapy. Patients will be randomized into two arms: Arm A (Experimental Arm) which omits regional nodal irradiation, and Arm B (Control Arm) which receives standard regional nodal irradiation.
- Conditions
- Breast Cancer
- Being tested
- Adjuvant Radiotherapy
- Keywords
- Regional Nodal Irradiation
- 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 RadiotherapyRadiation
Adjuvant radiation therapy will be delivered using Three-Dimensional Conformal Radiotherapy (3DCRT) or Intensity-Modulated Radiotherapy (IMRT). Standard institutional contouring and dosing protocols will be applied to the target volumes (whole breast or chest wall, with or without regional nodal regions) based on the randomized arm assignment.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Experimental Arm | Experimental | Patients will receive whole breast irradiation (WBI) following breast-conserving surgery or chest wall irradiation (CWI) following mastectomy, without regional nodal irradiation (RNI). Receives: Radiation: Adjuvant Radiotherapy |
| Arm B:Control Arm | Active comparator | Patients will receive standard whole breast irradiation (WBI) or chest wall irradiation (CWI) combined with standard regional nodal irradiation (RNI) according to institutional protocol and current international guidelines. Receives: Radiation: Adjuvant Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Locoregional Recurrence (LRR) Rate
The percentage of patients who experience tumor recurrence in the ipsilateral breast/chest wall or regional lymph nodes (axillary, supraclavicular, or internal mammary lymph nodes) during the follow-up period
Measured: 3 years
Secondary outcomes (3)
Invasive Disease-Free Survival (iDFS)
The time from randomization to the date of first documentation of invasive local, regional, or distant recurrence, contralateral invasive breast cancer, or death from any cause.
Measured: 5 years
Radiation Toxicity
Incidence of acute and late radiation toxicities, including lymphedema, radiation pneumonitis, cardiac toxicity, brachial plexopathy, and shoulder dysfunction, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: From start of radiotherapy up to 1 year post-treatment
Overall Survival (OS)
The time from randomization to the date of death from any cause.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2029 (estimated)
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.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aya Ahmed Sayed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aya Ahmed Sayed, Sohag University
- Investigators
- Mohamed Soliman, Study chair, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724769
- Sponsor's protocol ID
- Soh-Med--26-7-1MD
- Acronym
- OMIT-RNI
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared outside the study investigators.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparative Study of Response-Adapted De-escalation of Regional Nodal Irradiation in Initially Node Positive Breast Cancer Patients With Pathological Nodal Complete Response After Neoadjuvant Therapy
- ClinicalTrials.gov ID
- NCT07724769
- Acronym / sponsor ID
- OMIT-RNI / Soh-Med--26-7-1MD
- Conditions
- Breast Cancer
- Keywords
- Regional Nodal Irradiation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aya Ahmed SayedUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 24 Jul 2026 (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.
Prospective Comparative Study of Response-Adapted De-escalation of Regional Nodal Irradiation in Initially Node Positive Breast Cancer Patients with Pathological Nodal Complete Response After Neoadjuvant Therapy
Detailed description
This prospective, randomized comparative study aims to evaluate the clinical outcomes and safety of response-adapted de-escalation of Regional Nodal Irradiation (RNI) in initially node-positive (cN1) breast cancer patients who achieved a pathological nodal complete response (pCR) following neoadjuvant systemic therapy. Patients will be randomized into two arms: Arm A (Experimental Arm) which omits regional nodal irradiation, and Arm B (Control Arm) which receives standard regional nodal irradiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Experimental Arm | Experimental | Radiation: Adjuvant RadiotherapyPatients will receive whole breast irradiation (WBI) following breast-conserving surgery or chest wall irradiation (CWI) following mastectomy, without regional nodal irradiation (RNI). |
| Arm B:Control Arm | Active comparator | Radiation: Adjuvant RadiotherapyPatients will receive standard whole breast irradiation (WBI) or chest wall irradiation (CWI) combined with standard regional nodal irradiation (RNI) according to institutional protocol and current international guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female patients >= 18 years old.
- Histologically confirmed invasive breast cancer, cT1-3 N1M0 according to the 8th AJCC edition.
- Biopsy-proven cN1 disease at diagnosis.
- Completion of standard neoadjuvant systemic therapy.
- Surgical treatment of breast and axilla.
Key exclusion criteria (5 listed)
- Metastatic disease (M1).
- Prior thoracic irradiation.
- Pregnancy or lactation.
- Severe uncontrolled comorbid illness.
- Any contraindication to radiotherapy.
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 RadiotherapyAdjuvant radiation therapy will be delivered using Three-Dimensional Conformal Radiotherapy (3DCRT) or Intensity-Modulated Radiotherapy (IMRT). Standard institutional contouring and dosing protocols will be applied to the target volumes (whole breast or chest wall, with or without regional nodal regions) based on the randomized arm assignment. | Radiation | Arm A: Experimental Arm, Arm B:Control Arm |
Primary outcome
Locoregional Recurrence (LRR) Rate
Time frame: 3 years
The percentage of patients who experience tumor recurrence in the ipsilateral breast/chest wall or regional lymph nodes (axillary, supraclavicular, or internal mammary lymph nodes) during the follow-up period
3 secondary outcomes
Invasive Disease-Free Survival (iDFS)
Time frame: 5 years
Radiation Toxicity
Time frame: From start of radiotherapy up to 1 year post-treatment
Overall Survival (OS)
Time frame: 5 years
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 24 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared outside the study investigators.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Mohamed Soliman study chair
Sohag University
Questions about this trial
What is this clinical trial studying?
A study testing Adjuvant Radiotherapy in people with Breast Cancer, run by Aya Ahmed Sayed.
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: opening soon, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Contact Aya A Hussein, MD candidate (01023423815 ext. 0 11 539109, ayaahmed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Locoregional Recurrence (LRR) Rate (time frame: 3 years). 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 24 Jul 2026.