RecruitingNot Applicable

Omission of ALND in Breast Cancer Patients With Axillary pCR

China92 participantsStarted 2023-09-11

Plain-language summary

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.

Who can participate

Age range18 Years – 70 Years

SexFEMALE

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Inclusion criteria

✓. Female aged between 18 and 70 years;
✓. Pathologically confirmed invasive breast cancer (regardless of pathological type) with a clinical stage cT1-3;
✓. Pathologically confirmed positive axillary lymph nodes with a clinical stage of N1-3;
✓. Receiving a full course of neoadjuvant therapy (including neoadjuvant chemotherapy, neoadjuvant targeted therapy, neoadjuvant immunotherapy);
✓. Positive axillary lymph nodes successfully stained by carbon nanoparticles injection;
✓. All patients are required to undergo immunohistochemical staining for Estrogen Receptor (ER), Progesterone Receptor (PR), human epidermal growth factor receptor 2 (HER2), Ki- 67 proliferation index, and further fluorescence in situ hybridization (FISH) should be performed in HER2 2+ cases;
✓. Preoperative clinical assessment (including physical examination, imaging, with or without nomogram assessment) suggests positive axillary lymph nodes converted to negative (ycN0);
✓. ECOG score 0 - 1;

Exclusion criteria

What they're measuring

iDFS: invasive Disease-Free Survival after breast surgery

Timeframe: Up to 3 years after surgery

Trial details

NCT IDNCT05939830

SponsorThe First Affiliated Hospital with Nanjing Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07

Contact for this trial

Jue Wang, MD

+862568306360 wangjue200011@njmu.edu.cn

View on ClinicalTrials.gov More Axillary Lymph Node Dissection trials