Condition: Axillary Lymph Node Dissection · Pathological Complete Response · Neoadjuvant Systemic Therapy · Sponsor: The First Affiliated Hospital with Nanjing Medical University
This prospective, single-arm, phase II trial studies axillary lymph node dissection (ALND) to see if it can be safely omitted in breast cancer patients with axillary pathological complete response (pCR) after neoadjuvant systemic therapy (NST). Breast cancer patients with biopsy-proven positive axillary lymph nodes at initial diagnosis, and converted to negative after NST, which is confirmed by Stained region Lymph Node Biopsy(SrLNB), will be enrolled in the study. In other words, a total of 92 patients will be exempted from ALND after SrLNB, and afterwards complete regional node irradiation (RNI) including the axilla. They will also undergo adjuvant chemotherapy, targeted therapy, endocrinotherapy after surgery. These patients will be followed up in the next three years for local-regional recurrence and long-time survival outcome.
This description comes directly from the study's public registry record.
Jue Wang, MD · +862568306360 · wangjue200011@njmu.edu.cn
Lingjun Ma, MD · +8613186693728 · malingjun@stu.njmu.edu.cn
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| The First Affiliated Hospital of Nanjing Medical University | Nanjing, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05939830