A Phase III, Randomized, Open-label, Multicenter Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared with Physician's Choice of Adjuvant Endocrine Monotherapy in Patients with Estrogen Receptor-Positive, Her2-negative Early Breast Cancer (B-61) Lidera
Objective
Primary Objective- IDFS is defined as the time from randomization to first occurrence of one of the following IDFS events Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion) Ipsilateral locoregional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast) Distant recurrence (i.e., evidence of breast cancer in any anatomic site other than the two sites mentioned above that has either been histologically confirmed or clinically diagnosed as recurrent invasive breast cancer) Contralateral invasive breast cancer Death from any cause, including breast cancer, non-breast cancer, or unknown cause (but the cause of death should be specified, if possible) All second primary non-breast cancers and in situ carcinomas (including DCIS and LCIS) and non-melanoma skin cancers will be excluded as an event for this endpoint
