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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

NCT01597388

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