Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Breast Cancer
  • HER2 Positive Breast Cancer
  • Sentinel Lymph Node
  • Triple -Negative Breast Cancer
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Prospective non-inferiority cohort, single-arm registration trialMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

Axillary staging in clinically node negative (cN0) breast cancer patients with neoadjuvant systemic therapy (NST; i.e. chemo- and immunotherapy), is preferably performed with sentinel lymph node biopsy (SLNB) after NST. The probability of a tumor-positive SLNB post-NST is low. cN0 patients with Huma...

Axillary staging in clinically node negative (cN0) breast cancer patients with neoadjuvant systemic therapy (NST; i.e. chemo- and immunotherapy), is preferably performed with sentinel lymph node biopsy (SLNB) after NST. The probability of a tumor-positive SLNB post-NST is low. cN0 patients with Human Epidermal growth factor Receptor 2- positive (HER2+) or triple negative (TN) breast cancer who achieve radiologic complete response (rCR) of the breast on MRI, have the lowest probability of a tumor-positive SLNB post-NST (<3%). Omitting removal of axillary lymph nodes in clinically node negative patients does not increase the rate of distant metastases nor breast cancer mortality. Performing SLNB can cause short- and long-term morbidity, reducing quality of life. The additional value of performing SLNB in patients with a very low risk of tumor-positive axillary lymph nodes should be investigated.

Tracking Information

NCT #
NCT04225858
Collaborators
Not Provided
Investigators
Principal Investigator: Marie-Jeanne T.F.D. Vrancken Peeters, MD, PhD Antoni van Leeuwenhoek