Clinical Trials Logo
  1. Home
  2. Other
  3. NCT05141630

Axillary Sentinel or Targeted Lymph Node Biopsy Alone After Neoadjuvant Chemotherapy in Node-positive Breast Cancer

Breast Cancer Female Clinical Trial

Official title:
Safety of Axillary Sentinel or Targeted Lymph Node Biopsy Alone After Neoadjuvant Chemotherapy in Breast Cancer With Initial Axillary Metastasis

Clinical Trial Summary

This randomized phase II trial investigates the effectiveness of axillary sentinel or targeted lymph node biopsy alone after neoadjuvant chemotherapy (NAC) in breast cancer patients with initial axillary metastasis. For patients with the low nodal disease after NAC, it is not yet known if radiation therapy causes fewer side effects without compromising loco-regional control.

Clinical Trial Description

To evaluate long-term survival and life quality in patients with biopsy-proven node-positive (cN1-N2) breast cancer receiving NAC, followed by limited nodal burden (less than two positive lymph nodes) by using a (sentinel lymph node biopsy) SLNB or targeted axillary dissection (TAD) technique, and no further axillary surgery. OUTLINE: Eligible patients with cT1 to cT3 biopsy-proven N1-2 breast cancer rendered cN0 by NAC underwent SLNB with dual tracer mapping or TAD, and omission of ALND if 2 or more biopsied nodes were identified and less than 2 biopsied nodes were pathologically positve. Metastatic nodes were not routinely clipped, and localization of clipped nodes was performed in these patients. The study was performed in a single cancer center. After study treatment, patients are followed up at least every 6 months for 2 years and then annually for 3 years. PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study within 10 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05141630
Study type Interventional
Source Fudan University
Contact Zhi-Min Shao
Phone +86 21 6417 5590
Email zhimingshao@yahoo.com
Status Recruiting
Phase Phase 2
Start date January 1, 2014
Completion date January 1, 2024
View Details
See also
  Status Clinical Trial Phase
Completed NCT03080623 - Ultrasound-based Diagnostic Model for Differentiating Malignant Breast Lesion From Benign Lesion
Completed NCT05527769 - Pain and Functional Recovery After Mastectomy and IBR by Implant: Prepectoral Versus Subpectoral Technique
Completed NCT06376578 - Exercise Interventions for Improving Health in Breast Cancer Survivors N/A
Completed NCT03004534 - A Study to Evaluate Changes in Human Breast Cancer Tissue Following Short-Term Use of Darolutamide Early Phase 1
Recruiting NCT05020574 - Microbiome and Association With Implant Infections Phase 2
Active, not recruiting NCT06277141 - The Vitality Mammography Messaging Study N/A
Completed NCT03270111 - High Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women N/A
Completed NCT03555227 - USG PECS vs LIA for Breast Cancer Surgery N/A
Active, not recruiting NCT03917082 - Limited Adjuvant Endocrine Therapy for Low Risk Breast Cancer Phase 2
Recruiting NCT05561842 - Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria (Mobile Health: Technology and Outcomes in Low and Middle-Income Countries)
Completed NCT04554056 - Trial to Compare the Efficacy and Safety Of MW05 and PEG-rhG-CSF Phase 2/Phase 3
Active, not recruiting NCT03127995 - Hypofractionated vs Standard Radiotherapy in Breast Cancer With an Indication for Regional Lymph Node Irradiation About Lymphedema Occurrence N/A
Active, not recruiting NCT02237469 - Prone Breast Radiotherapy Treatment Planning Observational Study
Completed NCT01204125 - Two Regimens of SAR240550/Weekly Paclitaxel and Paclitaxel Alone as Neoadjuvant Therapy in Triple Negative Breast Cancer Patients Phase 2
Recruiting NCT04565054 - Adjuvant Therapy With Abemaciclib + SOC ET vs. SOC ET in Clinical or Genomic High Risk, HR+/HER2- EBC Phase 3
Not yet recruiting NCT06412133 - Conversations in Light and Shadow: Assessing Phototherapy's Impact on Breast Cancer Patients N/A
Recruiting NCT03956641 - Evolution of the Physical Condition in Treated Cancer Patients N/A
Recruiting NCT06087120 - Investigate the Prognostic and Predictive Value of ctDNA During Neoadjuvant Chemotherapy for Breast Cancer.
Recruiting NCT06058936 - Exercises Using Virtual Reality on Cancer Patients N/A
Completed NCT03470935 - Non-interventional Study Evaluating Gynecological Impact of Diagnosis and Treatment of Breast Cancer in Patients Younger