Advanced Breast Cancer Treatment Study
A phase III randomized double-blind, placebo controlled study of alpelisib in combination with fulvestrant for men and postmenopausal women with hormone receptor positive, HER2-negative advanced breast cancer which progressed on or after aromatase inhibitor treatment.
The purpose of this study is to learn whether alpelisib, when added to a marketed standard treatment (fulvestrant), helps to reduce the growth of breast cancer cells in people with hormone receptor-positive, HER2-negative advanced breast cancer.
In order to participate you must meet the following criteria:
- Have progression or recurrence during or after AI therapy.
Fall into one of the following categories:
- Have relapsed with documented evidence of progression while on or after completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease.
- Have relapsed with documented evidence of progression more than 12 months from completion of adjuvant endocrine therapy and then subsequently progressed with documented evidence of progression while on or after one line of endocrine therapy for metastatic disease.
- Have newly diagnosed advanced breast cancer, then relapsed with documented evidence of progression while on or after one line of endocrine therapy.
- Have at least one measurable lesion or primarily lytic bone lesion.
- Have a tumor that is clinically stable without corticosteroids, if brain metastases is present.
You will be excluded from the study if any of the following criteria apply to you:
- Have prior treatment with chemotherapy in the metastatic setting, fulvestrant, any PI3K, mTOR, or AKT inhibitor.
- Have diabetes mellitus type 1 or uncontrolled diabetes mellitus type 2.
- Have inflammatory breast cancer.
- Have not recovered from all toxicities related to prior anticancer therapies, except alopecia.
This is a partial list of inclusion and exclusion criteria.