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mTOR Kinase Inhibitor

AZD2014 + Fulvestrant for Breast Cancer

Phase 1
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
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 diabetes type 1 or uncontrolled type II (HbA1c > 8% assessed locally)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug, AZD2014, to see if it is safe to take with Fulvestrant, and how well it is tolerated.

Who is the study for?
This trial is for adults over 18 with ER+ advanced metastatic breast cancer, who can provide consent and have at least one lesion visible on scans. They must be in good physical condition (ECOG 0 or 1) and not able to bear children. Excluded are those who've had recent cancer treatments, severe heart conditions, major surgery within the last month, minor surgery within two weeks, or uncontrolled type I or II diabetes.
What is being tested?
The study tests the safety and tolerability of a drug combination: AZD2014 with Fulvestrant for treating ER+ advanced metastatic breast cancer. Participants will receive both medications to evaluate how well they work together.
What are the potential side effects?
While specific side effects aren't listed here, common ones from similar trials include nausea, fatigue, hormonal imbalances, potential blood clots due to Fulvestrant and possible organ-related issues from AZD2014.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have at least one cancer lesion that can be measured by scans.
Select...
My breast cancer is ER+ and can be treated with fulvestrant.
Select...
I am fully active or can carry out light work.
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not had major surgery in the last 4 weeks or minor surgery in the last 2 weeks.
Select...
I have type 1 diabetes or my type 2 diabetes is not well-controlled (HbA1c > 8%).
Select...
I do not have severe heart or lung conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Best Objective Response (BOR)
Clinical Benefit Rate (CBR) at 24 Weeks
Duration of Response (DoR)
+2 more

Side effects data

From 2020 Phase 2 trial • 18 Patients • NCT02831257
89%
Nausea
83%
Diarrhea
72%
Hyphophosphatemia
67%
fatigue
56%
Abdominal pain
50%
Weight loss
39%
mucositis
39%
Anorexia
39%
Dry mouth
33%
vomiting
33%
Dysgeusia
28%
aspartate aminotransferase increased
22%
Constipation
17%
infection
17%
High cholesterol
17%
Pruritis
17%
Rash, acneiform
17%
Hypertriglyceridemia
11%
Seizure
11%
Headache
11%
anemia
6%
vaginal pain
6%
Urticaria
6%
tachycardia
6%
Heat stroke
6%
Dry skin
6%
Hyperuricemia
6%
malaise
6%
Difficulty chewing
6%
amenorrhea
6%
white blood cells decreased
6%
Pneumonia
6%
Creatine phosphokinase increased
6%
Hematochezia
6%
Jaw weakness
6%
Dyspareunia
6%
Psychosis
6%
dyspepsia
6%
Acute kidney injury
6%
Alanine aminotransferase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
AZD2014

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: AZD2014 with FulvestrantExperimental Treatment2 Interventions
AZD2014 with Fulvestrant
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD2014
2015
Completed Phase 2
~1310
Fulvestrant
2011
Completed Phase 3
~3890

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,379 Previous Clinical Trials
288,740,191 Total Patients Enrolled
178 Trials studying Breast Cancer
1,245,939 Patients Enrolled for Breast Cancer
Howard Burris, MDStudy ChairSCRI Development Innovations, LLC
7 Previous Clinical Trials
316 Total Patients Enrolled
1 Trials studying Breast Cancer
40 Patients Enrolled for Breast Cancer

Media Library

AZD2014 (mTOR Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01597388 — Phase 1
Breast Cancer Research Study Groups: AZD2014 with Fulvestrant
Breast Cancer Clinical Trial 2023: AZD2014 Highlights & Side Effects. Trial Name: NCT01597388 — Phase 1
AZD2014 (mTOR Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01597388 — Phase 1
~7 spots leftby Oct 2025
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