locally advanced, recurrent, or metastatic breast cancer. Locally advanced breast cancer must not be amenable to curative treatment by surgery or radiotherapy.
Histological or cytological confirmation of estrogen-receptor positive (ER+) breast cancer
Postmenopausal women. Postmenopausal status is defined either by:
Prior bilateral oophorectomy
Or age ≥60
Or age < 60 and amenorrhea for 12 or more months
Recurrence or progression on prior NSAI is defined as:
Recurrence while on, or within one year (12 months) of end of adjuvant treatment with letrozole or anastrozole OR
Progression while on or within one month (30 days) of the end of prior treatment with letrozole or anastrozole
Radiological or objective evidence of recurrence or progression on or after the last systemic therapy prior to enrollment
Patient must have as per RECIST 1.1
• measurable disease or non-measurable lytic or mixed (lytic + blastic) bone lesions in the absence of measurable disease.
8. Patient is able to swallow and retain oral medication 9. Patient must meet the hematologic & biochemistery laboratory values at the screening visit:
Written informed consent must be obtained prior to any screening procedures
Patients eligible for this study must not meet any of the following criteria:
HER2-overexpressing patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive), based on the most recent test. Note: Patients with IHC 2+ must have a negative in situ hybridization test.
Patients who received more than one chemotherapy line for ABC
Patient with symptomatic visceral disease and is candidate to chemotherapy
Patients with only non-measurable lesions other than lytic or mixed (lytic and blastic) bone metastasis (e.g. pleural effusion, ascites etc.)
Patients receiving concomitant immunosuppressive agents or chronic corticosteroids use at the time of study entry except topical applications, inhaled sprays, eye drops or local injections.
Uncontrolled diabetes mellitus as defined by HbA1c >7% despite adequate therapy.
Other protocol-defined inclusion/exclusion criteria may apply"