Advanced or Metastatic Breast Cancer, ER+ve Advanced or Metastatic Breast Cancer
Conditions
Interventions
investigational material(s)
Generic name etc : AZD5363, Taxsol
INN of investigational material : Paclitaxel
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investi
Sponsors
AstraZeneca
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: -Provision of informed consent. -Histological or cytological confirmation of breast cancer with evidence of advanced or metastatic disease (must be ER+ve, HER2-ve, in Part B). -World Health Organisation (WHO) performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks.
Exclusion criteria
Exclusion criteria: -Clinically significant abnormalities of glucose metabolism. -Spinal cord compression or brain metastases unless asymptomatic, treated and stable (not requiring steroids). -Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV. -Any prior exposure to agents which inhibit AKT as the primary pharmacological activity. -Part A: more than two prior courses of chemotherapy (including taxanes) for advanced or metastatic breast cancer. Part B: any prior chemotherapy for advanced or metastatic breast cancer.
Outcome results
None listed