Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
FEMALE
NCT05939830

Omission of ALND in Breast Cancer Patients With Axillary pCR

Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2024-12-30

92

Participants Needed

1

Research Sites

146 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Omission of ALND in Breast Cancer Patients With Axillary pCR

Who Can Participate

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged between 18 and 70 years
  • Pathologically confirmed invasive breast cancer with clinical stage cT1-3
  • Pathologically confirmed positive axillary lymph nodes with clinical stage N1-3
  • Completed a full course of neoadjuvant therapy (chemotherapy, targeted therapy, immunotherapy)
  • Positive axillary lymph nodes marked by carbon nanoparticles injection
  • Immunohistochemical staining for ER, PR, HER2, Ki-67, and FISH if HER2 is 2+
  • Preoperative assessment shows axillary lymph nodes converted to negative (ycN0)
  • ECOG performance status of 0 or 1
  • Voluntary participation with signed informed consent
Not Eligible

You will not qualify if you...

  • Bilateral breast cancer
  • Breast cancer during lactation or pregnancy
  • Evidence of distant metastases by physical or imaging exam
  • Previous malignant tumor history
  • Previous surgery on affected axilla or upper extremity affecting function
  • Prior radiation therapy to breast or chest
  • Positive margins in breast-conserving surgery or mastectomy
  • Positive intraoperative rapid pathology for SrLNB (ypN+)
  • Unable to complete full prescribed adjuvant therapy follow-up
  • Elevated liver enzymes (AST, ALT), alkaline phosphatase, total bile, or serum creatinine above specified limits
  • Left ventricular ejection fraction less than 50%
  • Severe coagulation disorders, serious systemic diseases, or uncontrolled infections
  • Lack of personal freedom or independent civil capacity
  • Mental disorders, addictions, or deemed ineligible by investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Nanjing Medical University

Nanjing, China

Actively Recruiting

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Research Team

J

Jue Wang, MD

CONTACT

L

Lingjun Ma, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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