AZD2014 and Fulvestrant in Patients With ER+ Advanced Metastatic Breast Cancer
Completed · Phase 1
Conditions studied: Advanced Metastatic Breast Cancer
In brief
The purpose of this study is to assess safety and tolerability of AZD2014 when given in combination with Fulvestrant
Key facts
- Study ID
- NCT01597388
- Run by
- AstraZeneca
- People needed
- 99
- Starts
- 2012-05-08
- Expected to finish
- 2026-01-13
- Last updated by the study team
- 2026-02-24
Who can join
Age: 18 and older, up to 100. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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)
Where it is running
- Research Site — Sarasota, Florida, United States
- Research Site — Detroit, Michigan, United States
- Research Site — Oklahoma City, Oklahoma, United States
- Research Site — Greenville, South Carolina, United States
- Research Site — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.