Omission of ALND in Breast Cancer Patients With Axillary pCR

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

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.

Eligibility criteria

Qualifiers

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);

Disqualifiers

Bilateral breast cancer;

Breast cancer during lactation period or pregnancy;

Physical examination or imaging examination confirmed presence of distant metastases;

Previous history of malignant tumor;

Trial design

Treatments tested in this trial

  • Stained region Lymph Node Biopsy (SrLNB)
  • Regional lymph node radiotherapy (RNI) including the axilla

Treatment groups

92 Participants
are divided into 1 treatment group