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AZD2014 + Palbociclib + Fulvestrant for Estrogen Receptor Positive Metastatic Breast Cancer (PASTOR Trial)
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.
- Breast Cancer
PASTOR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPASTOR Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PASTOR Trial Design
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Who is running the clinical trial?
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- You have taken a specific type of medication called dual mTORC1/2 inhibitor in the past.You have taken certain medications that can affect the levels of the study drug within a specific time frame.Your heart function test shows that your heart is not working well.You are taking medications that can cause heart rhythm problems, or have conditions that can increase the risk of heart rhythm issues, such as heart failure, low potassium levels, or a family history of certain heart conditions.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.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.Your bone marrow, platelet, hemoglobin, liver function, and kidney function need to be within certain levels for you to participate.You have had certain heart or blood vessel procedures, heart attacks, heart-related chest pain, heart failure, certain heart rhythm problems, blood clots in the lungs, or certain types of stroke in the past year.You have a pre-existing kidney disease such as glomerulonephritis or nephrotic syndrome.You have had a stem cell or bone marrow transplant in the past.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.You have not been treated with specific medications called CDK4/6 inhibitors, everolimus, or any drugs that target the PI3K-mTOR pathway.You have ongoing severe nausea or vomiting, long-term digestive problems, trouble swallowing the study product, or have had major surgery on your intestines.Women who have gone through menopause and are at least 18 years old.You have received certain types of cancer treatment, including chemotherapy, radiation therapy, and some medications, within the past 14 days.You have severe liver problems, serious lung disease, unstable heart or breathing issues, uncontrolled high blood pressure, ongoing bleeding problems, or any active infections.You have taken certain medications that affect how other drugs work within a specific time period before the trial.You have hepatitis B, hepatitis C, or HIV.You have used proton pump inhibitors within a certain time period before the trial.You are allergic to the ingredients in AZD2014, Palbociclib, or Fulvestrant, or similar drugs.You have cancer that has spread to your brain or spinal cord and it is not under control, or you have symptoms from it. If you had brain or spinal cord cancer before, you can join if it was treated and stable for at least 4 weeks.You have had another type of cancer within the last 3 years, except for certain types of skin cancer or a specific condition in the cervix.Your heart's electrical activity is not within a safe range, or you have a history of certain heart conditions that can cause irregular heartbeats.You have important irregularities in the way your heart beats when at rest.You have advanced cancer that has spread to important organs and is causing severe symptoms or complications.You have uncontrolled Type II diabetes, which means your fasting blood sugar is consistently higher than 126 mg/dL.You are regularly taking coumadin, but you can take low-molecular-weight heparin or oral Factor Xa antagonists.You have a serious mental health condition that could make it risky for you to take part in the study.You have a known problem with blood clotting or bleeding.You have used certain medications to boost your blood cell production within the past 2 weeks.You have been diagnosed with advanced breast cancer that cannot be removed with surgery or treated with radiation to cure it.You have breast cancer that tests positive for estrogen.Your most recent tumor biopsy shows that you do not have the HER2 gene.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.
- Group 1: Triplet Combination (Dose Finding)
- Group 2: Triplet Combination (Dose Expansion)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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"
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