Spots Global Cancer Trial Database for Omission of ALND in Breast Cancer Patients With Axillary pCR

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Omission of ALND in Breast Cancer Patients With Axillary pCR

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

Study ID: NCT05939830

Conditions

Axillary Lymph Node Dissection

Pathological Complete Response

Neoadjuvant Systemic Therapy

Breast Cancer

Axillary Lymph

Interventions

Stained region Lymph Node Biopsy (SrLNB)

Regional lymph node radiotherapy (RNI) including the axilla

Study Description

Brief 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.

Detailed Description: