- Trial ID:
- Melissa Torrey
- 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
- 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
How else can Scripps help me?
We have a broad range of physician expertise and specialized medical services available. You can find a doctor online, call 1-800-SCRIPPS (1-800-727-4777) for personal help, or see related Scripps services.
How can I find trials that are accepting new participants?
For more information, see a list of trials that are recruiting, or call the clinical research office at 858-648-6402 for help.