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.
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
Breast CancerHR+HER2-negativeadvanced breast canceralpelisibfulvestrantPI3KPhase IIIER+PgR+menpostmenopausalaromatase inhibitorneoplasmsAromatase InhibitorsEstradiol
You can join if…
Open to people ages 18 years and up
If female, patient is postmenopausal
Patient has identified PIK3CA status
Patients may be:
relapsed with documented evidence of progression while on (neo) adjuvant endocrine therapy or within 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease;
relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine therapy and then subsequently; progressed with documented evidence of progression while on or after only one line of endocrine therapy for metastatic disease;
newly diagnosed advanced breast cancer, then relapsed with documented evidence of progression while on or after only one line of endocrine therapy
Patient has recurrence or progression of disease during or after AI therapy (i.e.
letrozole, anastrozole, exemestane).
Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive breast cancer by local laboratory and has HER2 negative breast cancer
Patient has either measurable disease per RECIST 1.1 criteria OR at least one predominantly lytic bone lesion must be present
Patient has adequate bone marrow function
You CAN'T join if...
Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's best judgment
Patient has received prior treatment with chemotherapy (except for neoadjuvant/adjuvant chemotherapy), fulvestrant, any PI3K, mTOR or AKT inhibitor (pre-treatment with CDK4/6 inhibitors is allowed)
Patient with inflammatory breast cancer at screening
Patients with Child pugh score B or C
Patients with an established diagnosis of diabetes mellitus type I or not controlled type II
Patient has Eastern Cooperative Oncology Group (ECOG) performance status 2 or more
Patient with CNS involvement unless he/she is at least 4 weeks from prior therapy completion to starting the study treatment and has stable CNS tumor at time of screening and not receiving steroids and/or enzyme inducing ant-epileptic medications for brain metastases
Patient has participated in a prior investigational study within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer
Patient has a history of acute pancreatitis within 1 year of screening or a past medical history of chronic pancreatitis
Patient who relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease
Other protocol-defined inclusion/esclusion criteria may apply.
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