The VIOLET Trial: A Pragmatic Phase II Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+/HER2− Early Breast Cancer Using Oncotype DX and Abemaciclib
Sponsor: Istituto Di Ricerche Farmacologiche Mario Negri
Phase: 2
Disease: Estrogen receptor-positive, HER2-negative invasive breast cancer
EU trial number: 2026-525457-37-00
Population: Adult women with stage II–IIIB estrogen receptor-positive (at least 10%), HER2-negative invasive breast cancer who are candidates for neoadjuvant chemotherapy and are not eligible for upfront breast-conserving surgery and/or have clinically node-positive disease requiring axillary dissection. Treatment selection is made by a multidisciplinary team using Oncotype DX recurrence score, tumour characteristics, menopausal status, and patient preferences.
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