A Phase III, Multicenter, Randomized, Open-label Study Evaluating The Efficacy And Safety of Inavolisib Plus Fulvestrant Versus Alpelisib Plus Fulvestrant In Patients with Hormone Receptor-positive, HER2-negative, PIK3CA Mutated, Locally Advanced Or Metastatic Breast Cancer Who Progressed During or After CDK4/6 Inhibitor and Endocrine Combination Therapy
Details
A Phase III, Mutlicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant versus Alpelisib Plus Fulvestrant in Patients with Hormone Receptor-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Who Progressed During or After CDK4/6 Inhibitor and Endocrine Combination Therapy
Eligibility
You can join if...
Inclusion Criteria:
Age > 60 years
Age > 60 years and > 12 months of amenorrhea plus follicle-stimulating hormone and plasma or serum estradiol levels within postmenopausal range by local laboratory assessment in the absence of oral contraceptive pills, hormone replacement therapy, or gonadotropin-releasing hormone analogue
Life expectancy of >6 months
Exclusion Criteria:
Metaplastic breast cancer
Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
History of or active inflammatory bowel disease (e.g., Crohn’s disease or ulcerative
colitis)