NCT01597388CompletedPhase 1
AZD2014 and Fulvestrant in Patients With ER+ Advanced Metastatic Breast Cancer
A Phase I, Open-label, Multicentre, Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD2014 Administered Orally in Combination With Intramuscular (IM) Fulvestrant to Patients With Estrogen Receptor Positive (ER+) Advanced, Metastatic Breast Cancer
Source: ClinicalTrials.gov · Last updated 24 Feb 2026
Brief summary (registry, in English)
The purpose of this study is to assess safety and tolerability of AZD2014 when given in combination with Fulvestrant
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 99 (actual)
- First submitted
- 28 Mar 2012
- Start date
- 8 May 2012
- Primary completion date
- 4 Aug 2016
- Lead sponsor
- AstraZeneca
- Diseases
- Metastatic breast cancer
- NCT number
- NCT01597388
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 99
- From 8 May 2012 to the primary completion date, 4 Aug 2016
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- Patients with diabetes type 1 or uncontrolled type II (HbA1c \> 8% assessed locally)
Who the study is looking for
- 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.
Age in the registry: 18 years to 100 years · Sex: Female · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Sarasota | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.