De-escalation of RNI in Breast Cancer Patients With pN0 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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07724769

Acronym

OMIT-RNI

Enrollment

100

Registered

2026-07-24

Start date

2026-06-01

Completion date

2029-06-01

Last updated

2026-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Regional Nodal Irradiation

Brief 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

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.

Interventions

RADIATIONAdjuvant Radiotherapy

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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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. * ECOG performance status 0-2. * Suitable for adjuvant radiotherapy. * Signed informed consent.

Exclusion criteria

* Metastatic disease (M1). * Prior thoracic irradiation. * Pregnancy or lactation. * Severe uncontrolled comorbid illness. * Any contraindication to radiotherapy.

Design outcomes

Primary

Measure	Time frame	Description
Locoregional Recurrence (LRR) Rate	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

Secondary

Measure	Time frame	Description
Invasive Disease-Free Survival (iDFS)	5 years	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.
Radiation Toxicity	From start of radiotherapy up to 1 year post-treatment	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.
Overall Survival (OS)	5 years	The time from randomization to the date of death from any cause.

Contacts

CONTACTAya A Hussein, MD candidate

ayaahmed@med.sohag.edu.eg01023423815

STUDY_CHAIRMohamed Soliman

Sohag University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 25, 2026