Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.
Joseph Kash, MD
To determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer, who received prior treatment with an Aromatase Inhibitor either as (neo)adjuvant or for advanced disease.
Sponsor: Novartis Pharmaceuticals Corp
- MALES MEETING OTHER CRITERIA ARE ELIGIBLE
- If female, patient is postmenopausal
- Relapsed with documented evidence of progression on or following endocrine therapy
- Recurrence or progression of disease during or after AI therapy (i.e. letrozole, anastrozole, exemestane).
- Confirmed diagnosis of estrogen-receptor positive (ER+) and HER2 negative breast cancer
- Adequate bone marrow function
- No prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, any PI3K, mTOR or AKT inhibitor (pre-treatment with CDK4/6 inhibitors is allowed)
- No inflammatory breast cancer at screening
- No established diagnosis of diabetes mellitus type I or not controlled type II
Pending IRB Approval for Recruiting
Kathy Seymour, BSN