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mTOR kinase inhibitor

AZD2014 + Palbociclib + Fulvestrant for Estrogen Receptor Positive Metastatic Breast Cancer (PASTOR Trial)

Phase 1
Waitlist Available
Led By Anja Wiliams
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Postmenopausal women aged ≥ 18 years
World Health Organisation/Eastern Cooperative Oncology Group (ECOG) performance status of patient is 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed every 8 weeks for approximately 16 months
Awards & highlights

PASTOR Trial Summary

This trial was designed to find the best dose of two drugs, AZD2014 and palbociclib, given with a third drug, fulvestrant, to treat postmenopausal women with estrogen receptor positive breast cancer that has spread. The trial was divided into three parts. Part A was to find the best dose of the three drugs given together. Part B was to study the safety and effectiveness of the three drugs given at the dose found in Part A. Part C was supposed to be a Phase 2 extension of the trial comparing the three drug combination to a combination of just two of the drugs, but it was never done.

Eligible Conditions
  • Breast Cancer

PASTOR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Women who have gone through menopause and are at least 18 years old.
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You are in good enough health to carry out daily activities without help, and you are expected to live for at least 12 more weeks.
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You have been diagnosed with advanced breast cancer that cannot be removed with surgery or treated with radiation to cure it.
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You need to have a lesion that can be measured accurately with a CT scan or MRI at the start of the study and during follow-up visits.
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For Part A: You have gone through menopause, can take fulvestrant, and have had up to 3 rounds of chemotherapy. You may have also been treated with CDK4/6 inhibitors. For Part B: You have gone through menopause, have advanced or spreading ER+ breast cancer, and have not responded to AIs like letrozole, anastrozole, or exemestane. You may have also had one round of chemotherapy for advanced breast cancer and have been treated with fulvestrant or letrozole in the past. Other previous treatments like tamoxifen are also allowed.
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If you want to join the genetic research part of the study, you need to sign a form agreeing to have samples taken for genetic testing. If you decide not to join the genetic part, it won't affect your ability to participate in the main study.

PASTOR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed every 8 weeks for approximately 16 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed every 8 weeks for approximately 16 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Parts A and B: Number of adverse events experienced by patients
Secondary outcome measures
Area under the plasma concentration-time curve from zero to 12 hours (AUC 0-12) for AZD 2014 and palbociclib.
Area under the plasma concentration-time curve from zero to 24 hours (AUC 0-24) for AZD 2014 and palbociclib.
Area under the plasma concentration-time curve from zero to infinity (AUC 0-∞) for AZD 2014 and palbociclib.
+12 more

PASTOR Trial Design

2Treatment groups
Experimental Treatment
Group I: Triplet Combination (Dose Finding)Experimental Treatment3 Interventions
Phase 1 triplet dose finding phase in 3-6 patients per cohort - approximately 30 patients depending on emerging data to determine the maximum tolerated dose (MTD) of the triplet.
Group II: Triplet Combination (Dose Expansion)Experimental Treatment3 Interventions
Additional patients will be enrolled at the dose determined in Part A.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AZD2014
2015
Completed Phase 2
~1290
Palbociclib
2017
Completed Phase 3
~3720
Fulvestrant
2011
Completed Phase 3
~3700

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,238 Previous Clinical Trials
288,471,367 Total Patients Enrolled
174 Trials studying Breast Cancer
1,246,339 Patients Enrolled for Breast Cancer
Anja WiliamsPrincipal InvestigatorSarah Cannon Research Institute UK
Erika Hamilton, M.D.Principal InvestigatorSCRI Development Innovations, LLC

Media Library

AZD2014 (mTOR kinase inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02599714 — Phase 1
Breast Cancer Research Study Groups: Triplet Combination (Dose Finding), Triplet Combination (Dose Expansion)
Breast Cancer Clinical Trial 2023: AZD2014 Highlights & Side Effects. Trial Name: NCT02599714 — Phase 1
AZD2014 (mTOR kinase inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02599714 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this clinical trial still available to participants?

"According to information on clinicaltrials.gov, this particular research study is not currently searching for participants. It was first posted in December 2015 and last updated in October 2022; however, there are presently over 2500 other trials that require volunteers."

Answered by AI

Have any prior studies been conducted with Fulvestrant?

"Presently, 242 studies are being conducted on fulvestrant with 42 of these in their third phase. Burgas, New jersey is the main hub for trials involving this medication; however, there are 11048 sites around the globe running evaluations as well."

Answered by AI

Is this research endeavor accepting participants who are at least 18 years of age?

"As per the enrollment requirements, study participants must be in their adolescent years (18+) and up to 130. A total of 75 spots are available for minors while 2439 slots have been allocated to those over 65 years old."

Answered by AI

How many individuals are eligible to partake in this research endeavor?

"Unfortunately, no new candidates are being accepted for this trial at the present time. This study was initially posted on December 7th 2015 and last modified on October 11th 2022. If you're in search of other studies, 2287 clinical trials associated with breast cancer and 242 involving Fulvestrant currently have open enrollment."

Answered by AI

What pathologies is Fulvestrant employed to address?

"Fulvestrant is routinely used to address malignant neoplasms, as well as pik3ca gene mutation, disease progression, and resistance to endocrine therapy."

Answered by AI

How well-tolerated is Fulvestrant by those using it therapeutically?

"Due to the limited evidence of safety and efficacy, Fulvestrant has been assigned a score of 1 on our risk scale."

Answered by AI

What is the geographic scope of this research endeavor?

"This trial is currently running at 5 sites across the USA, located in Detroit, Milwaukee and Nashville amongst other cities. It would be prudent to choose a site close by that minimizes any travel demands imposed on participants."

Answered by AI

Could I potentially take part in this research project?

"This clinical trial is actively recruiting fifty-four individuals between eighteen and one hundred thirty years of age with a specific type of breast cancer. To qualify, participants must have an Eastern Cooperative Oncology Group (ECOG) performance status no greater than 1 over the past two weeks, a minimum life expectancy of twelve weeks, be postmenopausal women or utilize highly effective methods of contraception for both the duration of the study and ninety days after their last dosage if they are under 50 unless they have irreversible premature ovarian failure, bilateral oophorectomy/salpinectomy/hysterectomy, use oral/injected/implanted"

Answered by AI
~6 spots leftby Mar 2025