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Completed

NCT Number: NCT01597388

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

The purpose of this study is to assess safety and tolerability of AZD2014 when given in combination with Fulvestrant

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Key information

Conditions

Advanced Metastatic Breast Cancer

Age range

18 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Sarasota, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

AZD2014

Drug

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

Fulvestrant

Drug

IM monthly after loading dose

Other names: faslodex

Primary outcomes

  1. Adverse Events

    Time frame: Up to 12 Months

  2. Adverse Events Leading to Dose Reduction of AZD2014

    Time frame: Up to 28 Days

  3. Clinically Important Changes in Haematology Parameters

    Time frame: Up to 12 Months

  4. Clinically Important Changes in Clinical Chemistry Parameters

    Time frame: Up to 12 Months

  5. Left Ventricular Ejection Fraction

    Time frame: 24 hours

  6. QTcF Over 24 Hours

    Time frame: 24 hours

  7. Post-Baseline Glucose Elevation

    Time frame: 28 Days

  8. Sitting Diastolic Blood Pressure

    Time frame: 28 Days

  9. Sitting Systolic Blood Pressure

    Time frame: 28 Days

  10. Respiratory Rate

    Time frame: 28 Days

  11. Heart Rate

    Time frame: 28 Days

  12. Body Temperature

    Time frame: 28 Days

  13. Oxygen Saturation

    Time frame: 28 Days

  14. AZD2014 Peak Plasma Concentration at Steady State (Cmax,ss) on Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant

    Time frame: 5 Days

  15. AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-12) Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant

    Time frame: 5 Days

  16. AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-24) Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant

    Time frame: 5 Days

  17. AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-t) Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant

    Time frame: 5 Days

  18. AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-∞) Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant

    Time frame: 5 Days

  19. AZD2014 Peak Plasma Concentration at Steady State (Cmax,ss) on Cycle 1 Day 15, BID Intermittent Dosing, With Fulvestrant

    Time frame: 15 Days

  20. Time to AZD2014 Peak Plasma Concentration at Steady State (Tmax,ss) on Cycle 1 Day 15, BID Intermittent Dosing, With Fulvestrant

    Time frame: 15 Days

  21. AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-12) Cycle 1 Day 15 Intermittent Dosing, With Fulvestrant

    Time frame: 15 Days

  22. AZD2014 Peak Plasma Concentration at Steady State (Cmax,ss) on Cycle 1 Day 22, Continuous Dosing, With Fulvestrant

    Time frame: 22 Days

  23. Time to AZD2014 Peak Plasma Concentration at Steady State (Tmax,ss) on Cycle 1 Day 22, Continuous Dosing, With Fulvestrant

    Time frame: 22 Days

  24. AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-12) Cycle 1 Day 22 Continuous Dosing, With Fulvestrant

    Time frame: 15 Days

Secondary outcomes

  1. AZD2014 Peak Plasma Concentration (Cmax) Following Single Dose, Fasted, no Fulvestrant.

    Time frame: 1 Day

  2. Time to AZD2014 Peak Plasma Concentration (Tmax) Following Single Dose, Fasted, no Fulvestrant.

    Time frame: 1 Day

  3. Area Under the Plasma Concentration-time Curve for AZD2014 From 0 to 12 Hours (AUC 0-12) Following Single Dose, Fasted, no Fulvestrant.

    Time frame: 1 Day

  4. Area Under the Plasma Concentration-time Curve for AZD2014 From 0 to Infinity (AUC 0-∞) Following Single Dose, Fasted, no Fulvestrant.

    Time frame: 1 Day

  5. Objective Response Rate

    Time frame: Up to 12 months

    Objective Response Rate (ORR) is defined as the number (%) of patients with a confirmed overall response of either complete response (CR) or partial response (PR).

  6. Best Objective Response (BOR)

    Time frame: Up to 12 months

    Best objective response was the best response a patient had following start of treatment but prior to starting any subsequent cancer therapy and prior to RECIST v1.1 progression or the last evaluable assessment in the absence of RECIST v1.1 progression.

  7. Duration of Response (DoR)

    Time frame: Up to 12 months

    Duration of response is defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression.

  8. Clinical Benefit Rate (CBR) at 24 Weeks

    Time frame: Up to 12 months

    The Clinical Benefit Rate (CBR) at 24 weeks is defined as the percentage of patients who had a confirmed BOR of CR or PR in the first 24 weeks or who demonstrated SD for a minimum interval of 24 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e., 161 days) following the start of treatment.

  9. Percentage Change From Baseline at 16 Weeks in Target Lesion (TL) Size.

    Time frame: Up to 12 months

    Baseline was defined as last evaluable assessment prior to starting treatment. Tumour size was the sum of the longest diameters of the target lesions. TLs are measurable tumour lesions.

  10. Progression Free Survival

    Time frame: Up to 12 months

  11. Progression Free Survival at 26 Weeks

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2016
Study completion
2026
First posted
May 14, 2012
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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