NEOadjuvant Abemaciclib and GIredestrant TriaL in Patients with ER-positive, HER2-negative Early Breast Cancer
Status:
RECRUITING
Trial end date:
2027-04-01
Target enrollment:
Participant gender:
Summary
The objective of the study is to evaluate the efficacy and the safety of abemaciclib and giredestrant before surgery in participants with early stage, oestrogen receptor-positive (ER+), human epidermal receptor 2 negative (HER2-) breast cancer (BC).
Primary objective:
● To evaluate the efficacy of abemaciclib and giredestrant in complete cell cycle arrest (CCCA) rate at Week 2.
Secondary objectives:
* To evaluate the efficacy of abemaciclib and giredestrant in reducing the relative Ki67 expression from baseline to Week 2
* To evaluate the efficacy of abemaciclib and giredestrant in risk of recurrence (ROR) score reduction, clinical and radiological tumor response;
* To evaluate the safety of abemaciclib and giredestrant.
Exploratory objectives:
* To evaluate the mechanisms of response and resistance to therapy;
* To evaluate the correlation between Ki-67% reduction and 18- Fluorothymidine (FLT) uptake reduction;
* To evaluate the pathological complete response (pCR) rate (ypT0/is, ypN0) of giredestrant plus abemaciclib