OncoMatch/Clinical Trials/NCT07376538
Response-Based Local Therapy for Regionally Advanced Breast Cancer
Is NCT07376538 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies non-drug interventions for breast cancer.
The goal of this interventional clinical trial is to evaluate if an individualized treatment strategy (involving radiation boost, surgery, and systemic consolidation) can improve progression-free survival in patients with breast cancer presenting with positive ipsilateral supraclavicular (ISLN) and/or internal mammary lymph nodes (IMLN). The main questions it aims to answer are: Is individualized hypofractionated radiotherapy with a local boost safe and effective when adjusted by the response to neoadjuvant treatment? Does local surgery provide benefit for patients who have high residual tumor burden in these lymph nodes after neoadjuvant treatment? How effective is intensified systemic therapy when tailored to the patient's molecular subtype?
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: radiation therapy
Lab requirements
Blood counts
absolute neutrophil count ≥ 1.5 × 10⁹/L; platelet count ≥ 100 × 10⁹/L; hemoglobin ≥ 9 g/dL (90 g/L)
Kidney function
serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min
Liver function
total bilirubin ≤ 1.5 × ULN; AST and/or ALT ≤ 2.5 × ULN
Cardiac function
INR ≤ 1.5 and PT/APTT ≤ 1.5 × ULN; exclusion of severe cardiac dysfunction, myocardial infarction, uncontrolled arrhythmia, or unstable angina within 3 months prior to enrollment; clinically significant pericardial disease
Adequate baseline organ function, defined as: absolute neutrophil count ≥ 1.5 × 10⁹/L; platelet count ≥ 100 × 10⁹/L; hemoglobin ≥ 9 g/dL (90 g/L); serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance ≥ 60 mL/min; total bilirubin ≤ 1.5 × ULN; AST and/or ALT ≤ 2.5 × ULN; INR ≤ 1.5 and PT/APTT ≤ 1.5 × ULN. Presence of severe or uncontrolled concomitant diseases, including severe cardiac dysfunction; myocardial infarction, uncontrolled arrhythmia, or unstable angina within 3 months prior to enrollment; clinically significant pericardial disease; or severe pulmonary disease.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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