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NCT Number: NCT07724769

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adjuvant radiotherapy

Radiation

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Invasive Disease-Free Survival (iDFS)

    Time frame: 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.

  2. Radiation Toxicity

    Time frame: 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.

  3. Overall Survival (OS)

    Time frame: 5 years

    The time from randomization to the date of death from any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Aya A Hussein, MD candidate

CONTACT

[email protected]

01023423815 ext. 0 11 539109

Sponsors and collaborators

Lead sponsor

Aya Ahmed Sayed

Other

Registry information

Official study 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

Acronym: OMIT-RNI

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 24, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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