A Phase I/II Study of BGT226 in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast Cancer

Inclusion criteria: All patients * Histologically-confirmed, advanced solid tumors * Progressive, recurrent unresectable disease Phase II expansion part (advanced breast cancer) * Confirmed positive hormone receptor (estrogen receptor and/or progesterone receptor) or positive HER-2 expression status * Disease progression/recurrence following hormonal or anti-HER-2 treatment for advanced disease * At least one but not more than two prior chemotherapy regimens for the unresectable tumor * Measurable disease by MRI or CT scan Cowden Syndrome patients with an advanced malignancy Genetic confirmation of Cowden Syndrome * Age ≥ 18 * World Health Organization (WHO) Performance Status of ≤ 2 Exclusion criteria: * Hematopoietic: * No diabetes mellitus or history of gestational diabetes mellitus * No acute or chronic renal disease * No acute or chronic liver disease * No acute or chronic pancreatitis * No impaired cardiac function or clinically significant cardiac diseases such as ventricular arrhythmia, congestive heart failure, uncontrolled hypertension * No acute myocardial infarction or unstable angina pectoris within the past 3 months * Not pregnant or nursing and fertile patients must use barrier contraceptives Other protocol-defined inclusion/exclusion criteria may apply.