De-escalation of RNI in Breast Cancer Patients With pN0 After Neoadjuvant Therapy

NCT07724769 | Not Yet Recruiting DMC

• 1 other identifier: Soh-Med--26-7-1MD
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Conditions

Breast Cancer

Keywords

Regional Nodal Irradiation

Outcome Measures

Primary Outcomes (1)

• 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

  3 years

Secondary Outcomes (3)

• Invasive Disease-Free Survival (iDFS)

  5 years

• Radiation Toxicity

  From start of radiotherapy up to 1 year post-treatment

• Overall Survival (OS)

  5 years

Study Arms (2)

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).

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.

Radiation: Adjuvant Radiotherapy

Interventions

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.

Arm A: Experimental Arm; Arm B:Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Aya Ahmed Sayed: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy, Adjuvant

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Radiotherapy

Study Officials

• Mohamed Soliman

  Sohag University

  STUDY CHAIR

Central Study Contacts

Aya A Hussein, MD candidate

CONTACT

01023423815; ayaahmed@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Clinical Oncology

Study Record Dates

• First Submitted: July 19, 2026
• First Posted: July 24, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share