AZD2014 and Fulvestrant in patients with ER+ Advanced Metastatic Breast Cancer

Inclusion Criteria

• Inclusion Criteria:
• - Provision of signed and dated written informed consent prior to any study specific procedures, sampling analysis
• - Aged at least 18
• - At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by computerised tomography (CT) magnetic resonance imaging (MRI) or plain X-ray and is suitable for repeated assessment
• - Histological or cytological confirmation of an ER+ advanced metastatic breast cancer tumour that is eligible for treatment with fulvestrant
• - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• - Patients must have evidence of non-child-bearing potential.
• Exclusion Criteria:
• - Prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents, and any investigational agents within 14 days of starting study treatment (not including palliative radiotherapy at focal sites)
• - Major surgery within 4 weeks prior to entry to the study (excluding placement of vascular access), or minor surgery within 2 weeks of entry into the study.
• - Patients with severe cardiac condition of ischemia, impaired ventricular function and arrhythmias, evidence of severe or uncontrolled systemic or current unstable or uncompensated respiratory or cardiac conditions.
• - Patients with diabetes type 1 or uncontrolled type II (HbA1c > 8% assessed locally)