Advanced Metastatic Breast CancerPhase 1NCT01597388

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

A Phase 1 study testing AZD2014 and Fulvestrant in people with Advanced Metastatic Breast Cancer, run by AstraZeneca at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 18 to 100 years, women only
Conditions the study is for: Advanced Metastatic Breast Cancer
What is being tested?: AZD2014 and Fulvestrant
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 99 participants
Where: 5 sitesUnited States
Study dates: 8 May 2012to 13 Jan 2026
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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)

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

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

Other trials in United States

About this study

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

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

Read the 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.

Conditions: Advanced Metastatic Breast Cancer
Being tested: AZD2014, Fulvestrant
Keywords: Estrogen receptor positive, Advanced metastatic breast cancer, Estrogen receptor positive advanced metastatic breast cancer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD2014Drug
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
FulvestrantDrug
Also called faslodex
IM monthly after loading dose

Study groups in NCT01597388
Study group	Role	What they receive
AZD2014 with Fulvestrant	Experimental	AZD2014 with Fulvestrant Receives: Drug: AZD2014; Drug: Fulvestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse Events
Measured: Up to 12 Months
Adverse Events Leading to Dose Reduction of AZD2014
Measured: Up to 28 Days
Clinically Important Changes in Haematology Parameters
Measured: Up to 12 Months
Clinically Important Changes in Clinical Chemistry Parameters
Measured: Up to 12 Months
Left Ventricular Ejection Fraction
Measured: 24 hours
QTcF Over 24 Hours
Measured: 24 hours
Post-Baseline Glucose Elevation
Measured: 28 Days
Sitting Diastolic Blood Pressure
Measured: 28 Days
Sitting Systolic Blood Pressure
Measured: 28 Days
Respiratory Rate
Measured: 28 Days
Heart Rate
Measured: 28 Days
Body Temperature
Measured: 28 Days
Oxygen Saturation
Measured: 28 Days
AZD2014 Peak Plasma Concentration at Steady State (Cmax,ss) on Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant
Measured: 5 Days
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-12) Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant
Measured: 5 Days
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-24) Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant
Measured: 5 Days
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-t) Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant
Measured: 5 Days
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-∞) Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant
Measured: 5 Days
AZD2014 Peak Plasma Concentration at Steady State (Cmax,ss) on Cycle 1 Day 15, BID Intermittent Dosing, With Fulvestrant
Measured: 15 Days
Time to AZD2014 Peak Plasma Concentration at Steady State (Tmax,ss) on Cycle 1 Day 15, BID Intermittent Dosing, With Fulvestrant
Measured: 15 Days
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-12) Cycle 1 Day 15 Intermittent Dosing, With Fulvestrant
Measured: 15 Days
AZD2014 Peak Plasma Concentration at Steady State (Cmax,ss) on Cycle 1 Day 22, Continuous Dosing, With Fulvestrant
Measured: 22 Days
Time to AZD2014 Peak Plasma Concentration at Steady State (Tmax,ss) on Cycle 1 Day 22, Continuous Dosing, With Fulvestrant
Measured: 22 Days
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-12) Cycle 1 Day 22 Continuous Dosing, With Fulvestrant
Measured: 15 Days

Secondary outcomes (11)

AZD2014 Peak Plasma Concentration (Cmax) Following Single Dose, Fasted, no Fulvestrant.
Measured: 1 Day
Time to AZD2014 Peak Plasma Concentration (Tmax) Following Single Dose, Fasted, no Fulvestrant.
Measured: 1 Day
Area Under the Plasma Concentration-time Curve for AZD2014 From 0 to 12 Hours (AUC 0-12) Following Single Dose, Fasted, no Fulvestrant.
Measured: 1 Day
Area Under the Plasma Concentration-time Curve for AZD2014 From 0 to Infinity (AUC 0-∞) Following Single Dose, Fasted, no Fulvestrant.
Measured: 1 Day
Objective Response Rate
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).
Measured: Up to 12 months
Best Objective Response (BOR)
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.
Measured: Up to 12 months
Duration of Response (DoR)
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.
Measured: Up to 12 months
Clinical Benefit Rate (CBR) at 24 Weeks
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.
Measured: Up to 12 months
Percentage Change From Baseline at 16 Weeks in Target Lesion (TL) Size.
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.
Measured: Up to 12 months
Progression Free Survival
Measured: Up to 12 months
Progression Free Survival at 26 Weeks
Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 May 201213 Jan 2026

First posted14 May 2012 (estimated)
Study start8 May 2012
Primary completion4 Aug 2016
Study completion13 Jan 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Advanced Metastatic Breast CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 99 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01597388
Sponsor's protocol ID: D2270C00005
Other IDs: BRE-196, 264477
Status last verified: Feb 2026
First submitted: 28 Mar 2012
Last updated: 24 Feb 2026
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingPhase 1/2
A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC)
Triple-Negative Breast Cancer (TNBC)
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
RecruitingPhase 1/2
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
Metastatic Breast Cancer, Metastatic Gastric Adenocarcinoma

All Advanced Metastatic Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01597388
Acronym / sponsor ID: D2270C00005
Conditions: Advanced Metastatic Breast Cancer
Keywords: Estrogen receptor positive, Advanced metastatic breast cancer, Estrogen receptor positive advanced metastatic breast cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 99 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 8 May 2012 (actual)
Primary completion: 4 Aug 2016 (actual)
Study completion: 13 Jan 2026 (actual)
First posted: 14 May 2012 (estimated)
Results: Posted 17 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
AZD2014 with Fulvestrant	Experimental	Drug: AZD2014, Drug: FulvestrantAZD2014 with Fulvestrant

Who may qualify

Ages: 18 to 100 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (4 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AZD2014Single 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	AZD2014 with Fulvestrant
FulvestrantAlso: faslodexIM monthly after loading dose	Drug	AZD2014 with Fulvestrant

Primary outcome

Adverse Events
Time frame: Up to 12 Months
Adverse Events Leading to Dose Reduction of AZD2014
Time frame: Up to 28 Days
Clinically Important Changes in Haematology Parameters
Time frame: Up to 12 Months
Clinically Important Changes in Clinical Chemistry Parameters
Time frame: Up to 12 Months
Left Ventricular Ejection Fraction
Time frame: 24 hours
QTcF Over 24 Hours
Time frame: 24 hours
Post-Baseline Glucose Elevation
Time frame: 28 Days
Sitting Diastolic Blood Pressure
Time frame: 28 Days
Sitting Systolic Blood Pressure
Time frame: 28 Days
Respiratory Rate
Time frame: 28 Days
Heart Rate
Time frame: 28 Days
Body Temperature
Time frame: 28 Days
Oxygen Saturation
Time frame: 28 Days
AZD2014 Peak Plasma Concentration at Steady State (Cmax,ss) on Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant
Time frame: 5 Days
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
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
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
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-∞) Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant
Time frame: 5 Days
AZD2014 Peak Plasma Concentration at Steady State (Cmax,ss) on Cycle 1 Day 15, BID Intermittent Dosing, With Fulvestrant
Time frame: 15 Days
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
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-12) Cycle 1 Day 15 Intermittent Dosing, With Fulvestrant
Time frame: 15 Days
AZD2014 Peak Plasma Concentration at Steady State (Cmax,ss) on Cycle 1 Day 22, Continuous Dosing, With Fulvestrant
Time frame: 22 Days
Time to AZD2014 Peak Plasma Concentration at Steady State (Tmax,ss) on Cycle 1 Day 22, Continuous Dosing, With Fulvestrant
Time frame: 22 Days
AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-12) Cycle 1 Day 22 Continuous Dosing, With Fulvestrant
Time frame: 15 Days

11 secondary outcomes

AZD2014 Peak Plasma Concentration (Cmax) Following Single Dose, Fasted, no Fulvestrant.
Time frame: 1 Day
Time to AZD2014 Peak Plasma Concentration (Tmax) Following Single Dose, Fasted, no Fulvestrant.
Time frame: 1 Day
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
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
Objective Response Rate
Time frame: Up to 12 months
Best Objective Response (BOR)
Time frame: Up to 12 months
Duration of Response (DoR)
Time frame: Up to 12 months
Clinical Benefit Rate (CBR) at 24 Weeks
Time frame: Up to 12 months
Percentage Change From Baseline at 16 Weeks in Target Lesion (TL) Size.
Time frame: Up to 12 months
Progression Free Survival
Time frame: Up to 12 months
Progression Free Survival at 26 Weeks
Time frame: Up to 12 months

Results and safety

Results posted to the registry on 17 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
35 mg BID Continuous	6	6
50 mg BID Continuous	13	13
75 mg QD Continuous	14	14
100 mg QD Continuous	10	10
125 mg BID Intermittent Days 1 and 2 (Fasted)	37	37
125 mg BID Intermittent Days 1 and 2 (Fed)	4	4
170 mg BID Intermittent Days 1 and 2 (Fasted)	8	8
170 mg BID Intermittent Days 1 and 2 (Fed)	5	5
125 mg BID Intermittent Days 1 and 4 (Fasted)	2	2

Primary outcome: Adverse Events

Time frame: Up to 12 Months. Number. Unit: Participants

Measure	35 mg BID Continuous n = 6	50 mg BID Continuous n = 13	75 mg QD Continuous n = 14	100 mg QD Continuous n = 10	125 mg BID Intermittent Days 1 and 2 (Fasted) n = 37	125 mg BID Intermittent Days 1 and 2 (Fed) n = 4	170 mg BID Intermittent Days 1 and 2 (Fasted) n = 8	170 mg BID Intermittent Days 1 and 2 (Fed) n = 5	125 mg BID Intermittent Days 1 and 4 (Fasted) n = 2
Any Adverse Event (AE)	6	13	14	10	37	4	8	5	2
Any AE, Causally Related to AZD2014	5	12	14	9	35	4	8	5	2
Any AE, Causally Related to Fulvestrant Only	2	3	6	3	12	0	2	0	1
Any AE of CTCAE Grade ≥ 3 (G3)	3	8	10	6	24	3	6	3	1
AEs of CTCAE G3, Causally Related to AZD2014	2	8	7	5	16	0	6	2	0
Any AE of CTCAE G3, Related to Fulvestrant Only	0	0	0	0	0	0	0	0	0
Any Adverse Event with Outcome of Death	0	0	1	0	0	0	0	0	0
AE with Outcome of Death, Related to AZD2014	0	0	0	0	0	0	0	0	0

Population analysed: The analysis population consisted of all participants who received at least one dose of AZD2014.

Primary outcome: Adverse Events Leading to Dose Reduction of AZD2014

Time frame: Up to 28 Days. Number. Unit: Participants

Measure	35 mg BID Continuous n = 6	50 mg BID Continuous n = 13	75 mg QD Continuous n = 14	100 mg QD Continuous n = 10	125 mg BID Intermittent Days 1 and 2 (Fasted) n = 37	125 mg BID Intermittent Days 1 and 2 (Fed) n = 4	170 mg BID Intermittent Days 1 and 2 (Fasted) n = 8	170 mg BID Intermittent Days 1 and 2 (Fed) n = 5	125 mg BID Intermittent Days 1 and 4 (Fasted) n = 2
Value	1	7	4	6	12	0	4	3	2

Population analysed: The analysis population consisted of all participants who received at least one dose of AZD2014.

Primary outcome: Clinically Important Changes in Haematology Parameters

Time frame: Up to 12 Months. Number. Unit: Participants

Measure	35 mg BID Continuous n = 6	50 mg BID Continuous n = 13	75 mg QD Continuous n = 14	100 mg QD Continuous n = 10	125 mg BID Intermittent Days 1 and 2 (Fasted) n = 37	125 mg BID Intermittent Days 1 and 2 (Fed) n = 4	170 mg BID Intermittent Days 1 and 2 (Fasted) n = 8	170 mg BID Intermittent Days 1 and 2 (Fed) n = 5	125 mg BID Intermittent Days 1 and 4 (Fasted) n = 2
Change in Hemoglobin ≥ 2 CTCAE Grades	0	0	0	0	0	0	0	0	0
Change in Hemoglobin to CTCAE Grade 3 or 4	0	0	0	0	0	0	0	0	0
Change in Leukocytes ≥ 2 CTCAE Grades	0	4	2	1	9	2	2	3	0
Change in Leukocytes to CTCAE Grade 3 or 4	0	1	1	0	1	0	0	0	0
Change in Lymphocytes ≥ 2 CTCAE Grades	2	6	8	5	10	0	1	2	1
Change in Lymphocytes to CTCAE Grade 3 or 4	0	3	3	0	7	1	1	1	1
Change in Neutrophils ≥ 2 CTCAE Grades	1	4	1	3	12	1	1	1	0
Change in Neutrophils to CTCAE Grade 3 or 4	0	1	1	0	2	0	0	0	0

Population analysed: The analysis population consisted of all participants who received at least one dose of AZD2014.

Primary outcome: Clinically Important Changes in Clinical Chemistry Parameters

Time frame: Up to 12 Months. Number. Unit: Participants

Measure	50 mg BID Continuous n = 13	75 mg QD Continuous n = 14	100 mg QD Continuous n = 10	125 mg BID Intermittent Days 1 and 2 (Fasted) n = 37	125 mg BID Intermittent Days 1 and 2 (Fed) n = 4	170 mg BID Intermittent Days 1 and 2 (Fasted) n = 8	170 mg BID Intermittent Days 1 and 2 (Fed) n = 5	125 mg BID Intermittent Days 1 and 4 (Fasted) n = 2
Change in ALT ≥ 2 CTCAE Grades	1	3	3	0	1	0	0	0
Change in ALT to CTCAE Grade 3 or 4	0	2	1	0	1	0	0	0
Change in AST ≥ 2 CTCAE Grades	2	3	2	2	0	0	0	1
Change in AST to CTCAE Grade 3 or 4	0	5	2	3	1	0	0	1
Change in Alk Phosphatase ≥ 2 CTCAE Grades	2	1	0	1	0	1	0	0
Change in Alk Phosphatase to CTCAE Grade 3 or 4	1	1	0	1	0	1	0	0
Change in Albumin ≥ 2 CTCAE Grades	1	2	2	6	1	2	1	0
Change in Albumin to CTCAE Grade 3 or 4	0	1	0	0	0	0	0	0

Population analysed: The analysis population consisted of all participants who received at least one dose of AZD2014.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
35 mg BID Continuous	0 of 6 (0%)	6 of 6 (100%)	Not reported
50 mg BID Continuous	1 of 13 (7.7%)	13 of 13 (100%)	Not reported
75 mg QD Continuous	3 of 14 (21.4%)	14 of 14 (100%)	Not reported
100 mg QD Continuous	1 of 10 (10%)	10 of 10 (100%)	Not reported
125 mg BID Intermittent Days 1 and 2 (Fasted)	7 of 37 (18.9%)	37 of 37 (100%)	Not reported
125 mg BID Intermittent Days 1 and 2 (Fed)	0 of 4 (0%)	4 of 4 (100%)	Not reported
170 mg BID Intermittent Days 1 and 2 (Fasted)	3 of 8 (37.5%)	8 of 8 (100%)	Not reported
170 mg BID Intermittent Days 1 and 2 (Fed)	1 of 5 (20%)	5 of 5 (100%)	Not reported
125 mg BID Intermittent Days 1 and 4 (Fasted)	0 of 2 (0%)	2 of 2 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
AstraZeneca Cancer Study Locator Service http://www.emergingmed.com/networks/AstraZeneca astrazeneca@emergingmed.com 1-877-400-4656Link provided by the sponsor.

Related trials for Advanced Metastatic Breast Cancer

RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingPhase 1/2
A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC)
Triple-Negative Breast Cancer (TNBC)
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
RecruitingPhase 1/2
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
Metastatic Breast Cancer, Metastatic Gastric Adenocarcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AZD2014 and Fulvestrant in people with Advanced Metastatic Breast Cancer, run by AstraZeneca at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: Up to 12 Months). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01597388.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.