NCT02437318

Who might be able to join this trial:

• If you are female, you must be postmenopausal.
• Your cancer must have been tested to determine the status of a gene called PIK3CA.
• You relapsed (cancer came back) with clear evidence it was growing while on, or within 12 months of finishing, hormone therapy given before/after surgery, and you have not yet had treatment for cancer that has spread.
• You relapsed more than 12 months after finishing hormone therapy given before/after surgery, and then your cancer grew again during or after one hormone therapy treatment for cancer that had spread.
• You were newly diagnosed with advanced breast cancer and your cancer grew during or after one hormone therapy treatment.
• Your cancer got worse during or after treatment with a type of hormone therapy called an aromatase inhibitor (such as letrozole, anastrozole, or exemestane).
• Your breast cancer has been confirmed by a lab test to be estrogen-receptor positive and HER2 negative.
• Your cancer can be measured on scans, or you have at least one bone lesion of a specific type (confirm with trial site).
• Your blood counts and bone marrow are working well enough (confirm with trial site).

Who may not be able to join:

• Your cancer has spread to organs in a way that is causing symptoms, or your overall disease burden makes hormone therapy unsuitable, as judged by the doctor.
• You have previously been treated with chemotherapy (other than chemotherapy given before or after surgery), the drug fulvestrant, or certain targeted drugs that affect the PI3K, mTOR, or AKT pathways.
• You have a type of breast cancer called inflammatory breast cancer.
• You have moderate or severe liver problems (known as Child-Pugh score B or C).
• You have Type 1 diabetes, or Type 2 diabetes that is not well controlled.
• Your general health and ability to carry out daily activities is significantly limited (confirm with trial site).
• Your cancer has spread to the brain or spinal cord, unless it has been stable for at least 4 weeks, you are not on steroids, and you are not taking certain anti-seizure medications.
• You have taken part in another clinical trial within 30 days before joining, or within a certain timeframe based on the previous trial drug (confirm with trial site).
• You have had a severe episode of pancreatitis (inflammation of the pancreas) within the past year, or have a history of long-term pancreatitis.
• You relapsed more than 12 months after finishing hormone therapy given before/after surgery but have not had any treatment for cancer that has spread.

Important: Always verify eligibility with the trial site directly before applying.