A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy And Safety Of Giredestrant Plus Everolimus Compared With Exemestane Plus Everolimus In Patients With Estrogen Receptor (Er)-Positive, Her2-Negative, Locally Advanced Or Metastatic Breast Cancer (Ml43171)
Disease Types: Breast Cancer Research
-ER (+), HER2 (-) locally advanced or metastatic adenocarcinoma of the breast not amenable to curative treatment with measurable disease or evaluable bone metastasis
-Prior endocrine therapy with CDK4/6i in adjuvant or metastatic setting and candidate for endocrine therapy
-No: prior treatment with another oral selective estrogen receptor degrader (SERD); more than 2 lines of systemic endocrine therapy in locally advanced or metastatic setting; prior chemotherapy in locally advanced or metastatic setting; known active uncontrolled or symptomatic CNS metastasis, carcinomatous meningitis, or leptomeningeal disease; active cardiac disease or history of cardiac dysfunction; known clinically significant history of liver disease; active inflammatory bowel disease, chronic diarrhea, short bowel syndrome, or major upper gastrointestinal surgery potentially affecting absorption; interstitial lung disease or severe dyspnea at rest or requiring oxygen.