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NCT07724769
De-escalation of RNI in Breast Cancer Patients With pN0 After Neoadjuvant Therapy
Conditions: Breast Cancer
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Aya Ahmed Sayed
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
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.
Source: ClinicalTrials.gov (NCT07724769). StuddyBuddy aggregates publicly available trial information.