NCT02273973

Who might be able to join this trial:

• You are female and have gone through menopause
• You have been diagnosed with invasive breast cancer, confirmed by a tissue sample (biopsy)
• Your tumor is at least 2 centimeters in size, measured by MRI scan
• Your cancer is classified as Stage I to operable Stage III (meaning it has not spread too far and surgery is possible)
• There is no evidence that your cancer has spread to other parts of the body
• Your breast cancer tests positive for estrogen receptors (ER+) and negative for a protein called HER2 (HER2-)
• Your cancer is suitable for surgical removal
• A biopsy sample from your tumor can be tested at a central lab for a specific gene change (PIK3CA mutation)
• You are generally able to carry out daily activities with little to no limitation (confirm with trial site)
• Your fasting blood sugar level is 125 mg/dL or below
• Your blood counts, kidney function, and liver function are within acceptable ranges (confirm with trial site)
• You are able and willing to attend all study visits and follow the study requirements

Who may not be able to join:

• You have had any previous treatment for your current invasive breast cancer
• Your tumor is classified as a very advanced local stage (cT4 or cN3) (confirm with trial site)
• You have breast cancer in both breasts, in multiple areas of the breast, or cancer that has already spread to other parts of the body
• You have already had surgery to remove the tumor, lymph nodes, or a sentinel lymph node biopsy
• You have Type 1 or Type 2 diabetes and take medication to control your blood sugar
• You are unable or unwilling to swallow pills
• You have a condition that affects how your body absorbs food or medication through the gut
• You have a history of or currently have inflammatory bowel conditions such as Crohn's disease or ulcerative colitis
• You have a heart condition involving an abnormal heart rhythm called long QT syndrome, or an abnormal result on a specific heart test (confirm with trial site)
• Your lung function test shows reduced ability to transfer oxygen into the blood (below 60% of expected) (confirm with trial site)
• You have significant heart or cardiovascular problems, including uncontrolled high blood pressure, unstable chest pain, a history of heart attack, or moderate to severe heart failure
• You have any reason you cannot have an MRI scan (for example, a pacemaker or metal implants)
• You currently have an active infection being treated with intravenous (IV) antibiotics
• You need supplemental oxygen every day
• You have a significant liver condition, including hepatitis, active alcohol misuse, or cirrhosis
• You have any other serious uncontrolled illness, lung condition, or metabolic problem that the study team considers a risk (confirm with trial site)
• You have had a serious injury in the 3 weeks before starting the study treatment
• You have had a major surgical procedure in the 4 weeks before starting the study treatment
• You have had another cancer in the past 5 years, with some exceptions such as certain early-stage or skin cancers (confirm with trial site)

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