A Phase 3 trial investigating individualized locoregional treatment of initially biopsy-proven node-positive breast cancer, NCT04281355, reached its primary completion date on 2025-12-31 but was withdrawn with 0 participants enrolled.
Background
In clinically node-positive (cN+) breast cancer, preoperative systemic therapy (PST) is common. With increasing rates of complete tumor eradication, there is a need for de-escalation of locoregional treatment in the interest of decreased morbidity. Axillary staging is crucial. Axillary lymph node dissection (ALND) comes at a high risk of arm morbidity. There is extreme divergence in the use of less extensive staging methods, such as targeted lymph node biopsy (TLNB), sentinel node biopsy (SNB), or both (TAD).
Trial design
This Phase 3 study, titled "Individualized Locoregional Treatment of Initially Biopsy-proven Node-positive Breast Cancer After Primary Systemic Therapy," was designed to investigate individualized locoregional treatment strategies for Breast Cancer. The trial was withdrawn with an enrollment of 0 participants.
What this means
Since this trial was withdrawn prior to enrolling any participants, no clinical data was generated regarding individualized locoregional treatment for breast cancer from this specific study. Therefore, there are no new clinical implications for patients from this trial's findings.
Source
The information regarding this trial's status was obtained from ClinicalTrials.gov, a public database of clinical studies. The record for study NCT04281355, indicating its primary completion and withdrawn status, was updated on 2025-12-31 on clinicaltrials.gov.