Investigating safety, tolerability and efficacy of AZD5363 when combined with paclitaxel in breast cancer patients.
- Conditions
- Advanced or metastatic breast cancer, ER+ve advanced or metastatic breast cancer, safety and tolerability, pharmacokinetics, pharmacodynamics, tumour response, PIK3CATherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-006312-31-CZ
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 148
Provision of informed consent
Female Patients
Aged at least 18 years
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140
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 phamacological 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method