- Trial ID:
- Melissa Torrey
Inclusion Criteria: - 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 Exclusion Criteria: - 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.
Why isn't this trial accepting new patients?
The trial may have a limited enrollment number, reached its maximum, or come to the end of its enrollment period. View trials that are recruiting
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