Clinical Trial

Pragmatic Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+/HER2- Early Breast Cancer Using Oncotype DX and Abemaciclib

Study acronym: VIOLET
Not Yet Recruiting Phase 2
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Summary
This is a pragmatic phase 2 study to determine the proportion of patients with ER+ (≥10%)/HER2- EBC in whom neoadjuvant chemotherapy can be replaced by NET plus abemaciclib based on the results of the ODX RS obtained in the initial diagnostic biopsy and according to the MDT decision and to evaluate the proportion of patients undergoing breast conservative surgery and/or sentinel node biopsy
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-02-17.
Trial Details
NCT Number NCT07428018
Lead Sponsor Mario Negri Institute for Pharmacological Research
Collaborators: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Humanitas Research Hospital IRCCS, Rozzano-Milan, IRCCS San Raffaele, IEO Foundation, Papa Giovanni XXIII Hospital
Conditions Breast Cancer, HER2 + Breast Cancer, HR Positive, Neoadjuvant Therapy
Enrollment 150 participants
Start Date 2026-04-30
Primary Completion 2029-04-30 (estimated)
Study Completion 2029-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-05