A Pragmatic Phase II Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+/HER2− Early Breast Cancer Using Oncotype DX and Abemaciclib - VIOLET trial

Condition studied

HER2-negative, stage II–IIIB, neoadjuvant chemotherapy, estrogen receptor–positive,, breast carcinoma

Investigational medicinal product(s)

Every trial of Abemaciclib and Paclitaxel across our registers →

Eligibility

Primary endpoint

the proportion of enrolled patients treated with NET plus abemaciclib without receiving neoadjuvant or adjuvant chemotherapy. Patients receiving chemotherapy at any time after study enrollment, or refusing the MDT-recommended NET plus abemaciclib strategy, will be considered failures, the proportion of patients achieving surgical de-escalation after neoadjuvant therapy, defined as conversion from mastectomy to breast-conserving surgery and/or from axillary lymph node dissection to sentinel lymph node biopsy, according to comparison between baseline MDT surgical recommendation and definitive surgery performed.

Endpoint detail

Secondary Endpoints will be evaluated in the overall population and according to the neoadjuvant treatment received (NET+abemaciclib and NCT group) and include: ● the ORR, Secondary Endpoints will be evaluated in the overall population and according to the neoadjuvant treatment received (NET+abemaciclib and NCT group) and include: ●the rate of pathological complete response (pCR), Secondary Endpoints will be evaluated in the overall population and according to the neoadjuvant treatment received (NET+abemaciclib and NCT group) and include: ●the rate of discordancy between the technical suitability of BCS and the actual performance of mastectomy, and the reasons for the discordancy., Secondary Endpoints will be evaluated in the overall population and according to the neoadjuvant treatment received (NET+abemaciclib and NCT group) and include: ● the QoL change from baseline during neoadjuvant therapy measured by EORTC QLQ-C30, EORTC QLQ-BR42 and EORTC QLQ-FA12 questionnaires, Secondary Endpoints will be evaluated in the overall population and according to the neoadjuvant treatment received (NET+abemaciclib and NCT group) and include: ●the 6- and 12-month event (locoregional and distant progression)-free survival rates, Secondary Endpoints will be evaluated in the overall population and according to the neoadjuvant treatment received (NET+abemaciclib and NCT group) and include: ●Adverse Events as per CTCAE v.6.0