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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.

Phase 2RecruitingCancer Institute and Hospital, Chinese Academy of Medical SciencesNCT07376538Data as of May 2026

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?

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)

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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