Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer

Inclusion Criteria

• •Postmenopausal women with metastatic, recurrent or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.
• •Histological or cytological confirmation of hormone-receptor positive (HR+) breast cancer.
• •Disease refractory to non-steroidal aromatase inhibitors, defined as:
• •Recurrence while on, or within 12 months (365 days) of completion of adjuvant therapy with letrozole or anastrozole, or
• •Progression while on, or within one month (30 days) of completion of letrozole or anastrozole treatment for locally advanced or metastatic breast cancer (ABC).
• •Radiological or objective evidence of recurrence or progression on or after the last systemic therapy prior to enrolment.
• •Patients must have had:
• •At least one lesion that could have been accurately measured in at least one dimension
• •* 20 mm with conventional imaging techniques or ≥ 10 mm with spiral CT or MRI, or
• •Bone lesions: lytic or mixed (lytic + blastic) in the absence of measurable disease as defined above.
• •Adequate bone marrow, coagulation, liver and renal function.
• •ECOG performance status ≤ 2.