A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared with the Physician's Choice of Endocrine Therapy Plus Everolimus in Patients with Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
Details
This Phase III, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus everolimus compared with the physician's choice of endocrine therapy plus everolimus in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have had previous treatment with cyclin-dependent kinase 4/6 inhibitors (CDK4/6is) and endocrine therapy, either in the locally advanced/metastatic or the adjuvant setting.
Eligibility
You can join if...
Inclusion Criteria
Patients at least 18 years old at the time of signing informed consent form
Patients with advanced unresectable or metastatic adenocarcinoma of the breast
Patients willing and able to use an electronic device for PRO data collection
Exclusion Criteria
Patients with prior chemotherapy for locally advanced unresectable or metastatic disease
Patients with any investigationaly therapy within 28 days prior to initiation of study treatment
Patients with major surgery, chemotherapy, radiotherapy, or other anti-cancer therapy within 14 days prior to randomization