Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer

Open to females ages 18-100

• Postmenopausal, Estrogen-receptor positive and/or Progesterone-receptor positive breast cancer
• Phase Ib dose escalation only: Any number of prior lines of endocrine therapy is allowed with the exception of cytotoxic therapy which is limited to one prior line administered in the advanced (metastatic or locally advanced) setting.
• Phase Ib dose expansions Arms 1, 2 and 3
• No prior systemic treatment in the advanced (metastatic or locally advanced) setting with the exception of treatment with letrozole for a maximum of one month prior to starting study treatment.
• Patients who received (neo)adjuvant therapy for breast cancer are eligible. Prior therapy with letrozole or anastrozole in the (neo)adjuvant setting is permitted if the disease-free interval is greater than 12 months from the completion of treatment.

• HER2-overexpression in the patient's tumor tissue
• Patients with active CNS or other brain metastases
• Major surgery within 2 weeks
• Acute or chronic pancreatitis
• Bilateral diffuse lymphangitic carcinomatosis
• Another malignancy within 3 years
• Receiving hormone replacement therapy that cannot be discontinued
• Impaired cardiac function
• Patients with clinically manifest diabetes mellitus (treated and/or clinical signs or with fasting glucose ≥ 126 mg/dL / 7.0 mmol/L or hemoglobin A1c >6.5%), history of gestational diabetes mellitus or documented steroid-induced diabetes mellitus.
• Other protocol-defined inclusion/exclusion criteria may apply