Breast Cancer Clinical Trial

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

Summary

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

View Full Description

Full 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.

View Eligibility Criteria

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)

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

99

Study ID:

NCT01597388

Recruitment Status:

Active, not recruiting

Sponsor:

AstraZeneca

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 5 Locations for this study

See Locations Near You

Research Site
Sarasota Florida, 34232, United States
Research Site
Detroit Michigan, 48201, United States
Research Site
Oklahoma City Oklahoma, 73104, United States
Research Site
Greenville South Carolina, 29605, United States
Research Site
Nashville Tennessee, 37203, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

99

Study ID:

NCT01597388

Recruitment Status:

Active, not recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider