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AZD2014 and Fulvestrant in Patients With ER+ Advanced Metastatic Breast Cancer
AZD2014 and Fulvestrant in Patients With ER+ Advanced Metastatic Breast Cancer
CompletedPhase 1
Sponsor: AstraZeneca
Conditions: Advanced Metastatic Breast Cancer
Interventions: AZD2014, Fulvestrant
Countries: United States
The purpose of this study is to assess safety and tolerability of AZD2014 when given in combination with Fulvestrant
Eligibility overview
Sex: FEMALE
Age: 18 Years to 100 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility 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)
Locations (5)
- Sarasota, Florida, United States
- Detroit, Michigan, United States
- Oklahoma City, Oklahoma, United States
- Greenville, South Carolina, United States
- Nashville, Tennessee, United States