RecruitingNot ApplicableNCT05939830

Omission of ALND in Breast Cancer Patients With Axillary pCR

Omission of Axillary Lymph Node Dissection in Breast Cancer Patients With Axillary Pathological Complete Response After Neoadjuvant Systemic Therapy

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

92 participants

Start Date

Sep 11, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Axillary Lymph Node Dissection Pathological Complete Response Neoadjuvant Systemic Therapy Axillary Lymph

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether it is safe to skip the removal of underarm (axillary) lymph nodes in breast cancer patients who had cancerous lymph nodes before chemotherapy but showed no remaining cancer in those nodes after chemotherapy (a complete response). **You may be eligible if...** - You are female, between 18 and 70 years old - You have invasive breast cancer (stage cT1–3) confirmed by biopsy - Your underarm lymph nodes were positive for cancer before chemotherapy (stage N1–3) - You have completed a full course of neoadjuvant (pre-surgery) chemotherapy - Your lymph nodes show no remaining cancer after chemotherapy (pathological complete response) **You may NOT be eligible if...** - You still have cancer in your lymph nodes after chemotherapy - You had stage 4 (metastatic) breast cancer - You had prior breast or underarm surgery that would affect lymph node evaluation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREStained region Lymph Node Biopsy (SrLNB)

Before NST, carbon nanoparticles suspension would be injected into the cortex of positive lymph nodes for staining under ultrasound guidance. Marked lymph nodes will be removed and biopsied after NST.

RADIATIONRegional lymph node radiotherapy (RNI) including the axilla

RNI including the axilla covers the supraclavicular region and entire axillary lymphatic drainage area (region I, II and III) ,and is at a dose of 50 Gy/25 times, with additional prophylactic irradiation of the internal breast lymphatic drainage area for eligible patients.

Locations(1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, China

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NCT05939830

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