De-escalation of RNI in Breast Cancer Patients With pN0 After Neoadjuvant Therapy | NCT07724769

NCT07724769

Overview

NCT ID: NCT07724769
Lead Sponsor: Aya Ahmed SayedOTHER
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
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
Interventions: Adjuvant Radiotherapy

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 24, 2026Actual
Start Date: Jun 2026Estimated
Primary Completion Date: Jun 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 100Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Aya A Hussein, MD candidateContact
ayaahmed@med.sohag.edu.eg01023423815 ext. 0 11 539109

Similar Studies

Participant Group/Arms

Arm A: Experimental ArmExperimental

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 ArmActive 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