“Basic Experimental Studies Involving Humans” no longer classified as clinical trials at NIH in an effort to reduce administrative burden

Positive topline results have come out of the randomized phase II FOURLIGHT-1 study evaluating atirmociclib in combination with fulvestrant, versus fulvestrant or everolimus plus exemestane, in people with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer who had received prior cyclin-dependent kinase 4/6 inhibitor-based treatment. 

The phase III persevERA Breast Cancer study, evaluating investigational giredestrant in combination with palbociclib for people with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, did not meet its primary objective of a statistically significant improvement in progression-free survival in the intent-to-treat population versus letrozole plus palbociclib, but a numerical improvement was observed.