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AZD2014 and Fulvestrant in Patients With ER+ Advanced Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: March 28, 2012
Last updated: July 25, 2017
Last verified: July 2017
The purpose of this study is to assess safety and tolerability of AZD2014 when given in combination with Fulvestrant.

Condition Intervention Phase
Advanced Metastatic Breast Cancer Drug: AZD2014 Drug: Fulvestrant Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Assessment of safety and tolerability of AZD2014, when given in combination with fulvestrant, by assessment of: adverse events, clinical chemistry and haematology laboratory parameters, ECG data, vital signs and physical examination. [ Time Frame: From screening until the end of the follow up period, an expected average of 6 months ]
  • Determination of the steady state/multiple dose PK profile of AZD2014 in combination with fulvestrant by assessments including:maximum plasma concentration of AZD2014 (Cmax),time to Cmax and area under the plasma concentration-time curve (AUC). [ Time Frame: At multiple time-points on Day 22 of multiple continuous dosing, Day 23 of intermittent Day 1 and 2 dosing or the fourth day of intermittent Day 1 and 4 dosing ]

Secondary Outcome Measures:
  • Determination of the minimum plasma concentration at steady state of fulvestrant when administered in combination with AZD2014. [ Time Frame: Samples will be obtained on Day 29 and Day 57 of multiple dosing ]
  • Determination of the single dose PK profile of AZD2014,by assessments including: maximum plasma concentration (Cmax),time to Cmax,terminal rate constant half life,area under the plasma concentration-time curve (AUC0-12 and AUC0-24). [ Time Frame: At multiple time-points: for continuous dosing, on the day of single dosing (up to 5 days prior to the start of multiple dosing); for Day 1 & 2 intermittent, on the first dose of week 3; for Day 1 & 4 intermittent, on the first day of dosing. ]
  • Obtain a preliminary assessment of the anti-tumour activity of AZD2014, when given in combination with fulvestrant, by evaluation of tumour response using Response Evaluation Criteria in Solid Tumours (RECIST Version 1.1) [ Time Frame: At screening and every 8 weeks until progression, an expected average of 6 months ]

Enrollment: 99
Actual Study Start Date: May 8, 2012
Estimated Study Completion Date: December 12, 2017
Primary Completion Date: August 4, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD2014 with Fulvestrant
AZD2014 with Fulvestrant
Drug: AZD2014
Single dose followed by multiple dosing or twice daily dosing for 2 days folllowed by 5 days off each week, or twice daily dosing on the first and fourth day of the week
Drug: Fulvestrant
IM monthly after loading dose
Other Name: faslodex

Detailed Description:
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.

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01597388

United States, Florida
Research Site
Sarasota, Florida, United States, 34232
United States, Michigan
Research Site
Detroit, Michigan, United States, 48201
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States, 73104
United States, South Carolina
Research Site
Greenville, South Carolina, United States, 29605
United States, Tennessee
Research Site
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Study Chair: Howard Burris, MD SCRI Development Innovations, LLC
  More Information

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT01597388     History of Changes
Other Study ID Numbers: D2270C00005
Study First Received: March 28, 2012
Last Updated: July 25, 2017

Keywords provided by AstraZeneca:
Estrogen receptor positive
Advanced metastatic breast cancer
Estrogen receptor positive advanced metastatic breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists processed this record on September 21, 2017