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

N/ANot Yet RecruitingNCT07724769

Aya Ahmed Sayed100 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Breast Cancer

Interventions

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 3 years

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 5 years

Central Contacts

Aya A Hussein, MD candidate

CONTACT

01023423815 ayaahmed@med.sohag.edu.eg

Data from ClinicalTrials.gov

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