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

Study acronym: VIOLET
StatusNot Yet Recruiting
PhasePhase 2
Started
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Record History

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  1. Study title shortened, about 2 wordsv2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
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
(from sponsor)		 Breast Cancer, HER2 + Breast Cancer, HR Positive, Neoadjuvant Therapy
Related terms Breast Neoplasms
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov