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PI3K inhibitor
BYL719 + Letrozole for Breast Cancer
Phase 1
Waitlist Available
Led By Ingrid Mayer
Research Sponsored by Vanderbilt-Ingram Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prior radiation castration with amenorrhea for at least 6 months
NOTE: Treatment with a luteinizing hormone-releasing hormone (LH-RH) agonist (such as goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppression
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months of study treatment
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of the PI3K inhibitor BYL719 given with letrozole to treat hormone receptor-positive metastatic breast cancer.
Who is the study for?
This trial is for post-menopausal women with hormone receptor-positive metastatic breast cancer. Participants must have had prior endocrine therapy, be able to swallow pills, and have a life expectancy of at least 6 months. They need proper organ function and no severe heart conditions or uncontrolled illnesses.Check my eligibility
What is being tested?
The study is testing the combination of BYL719 (a PI3K inhibitor) and letrozole to see if they are more effective together in stopping tumor growth compared to standard treatments. The trial will also determine the safest doses of BYL719 when used with letrozole.See study design
What are the potential side effects?
Potential side effects include issues related to blocking proteins needed for cell growth which may affect healthy cells as well, leading to fatigue, digestive problems, blood sugar changes, and possible hormonal imbalances.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not had a period for at least 6 months due to radiation treatment.
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I am not using hormone therapy to suppress my ovaries.
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My breast cancer is stage IV, ER/PR positive, and HER2 negative.
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I have received hormone therapy for my breast cancer that has spread.
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I have tissue samples from my cancer diagnosis available for study.
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I am fully active or can carry out light work.
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I have had both of my ovaries removed.
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I can swallow and keep down pills.
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I am post-menopausal.
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I am under 55 and have not had a period for 12 months or my hormone levels indicate menopause.
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I am 55 years old or older.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 6 months of study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months of study treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose of BYL719 in combination with letrozole
Secondary outcome measures
Clinical benefit rate
Highest tolerated dose of BYL719 in combination with letrozole
Overall progression-free survival
+2 moreSide effects data
From 2017 Phase 1 trial • 17 Patients • NCT0203801091%
Aspartate Aminotransferase Increased
82%
Hyperglycemia
82%
Peripheral Sensory Neuropathy
73%
Anemia
73%
Fatigue
64%
Hypokalemia
64%
Hypoalbuminemia
64%
Alkaline Phosphatase Increased
55%
Cough
55%
Rash Maculo-papular
55%
Lymphocyte Count Decrease
55%
Platelet Count Decrease
45%
Alanine Aminotransferase Increased
45%
Blood Bilirubin Increased
45%
Sinus Tachycardia
36%
Elevated Hemoglobin A1C
36%
Nausea
36%
Dry Mouth
36%
Headache
27%
Epistaxis
27%
Diarrhea
27%
Hypocalcemia
27%
White Blood Cell Decrease
27%
Blurred Vision
27%
Urinary Tract Infection
27%
Neutrophil Count Decrease
18%
Anorexia
18%
Hypertension
18%
Dyspnea
18%
Activated Partial Thromboplastin Time Prolonged
18%
Pain
18%
Electrocardiogram QT Corrected Interval Prolonged
18%
Weight Loss
18%
Constipation
18%
Edema Limbs
18%
Dizziness
9%
Post- Menopausal Bleeding
9%
Left Ventricular Systolic Dysfunction
9%
Abdominal Pain
9%
Pancreatitis
9%
Fractured Rib
9%
Floaters
9%
Palpitations
9%
Right Bundle Block
9%
Acute pancreatitis
9%
Dry Eye
9%
Mucosal Infection
9%
Back Pain
9%
Hematuria
9%
Non-Cardiac Chest Pain
9%
Insomnia
9%
Sebaceous Cyst
9%
Pancreatic Insufficiency
9%
Ascites
9%
Elevated Fasting Plasma
9%
Alopecia
9%
Hypoxemia
9%
Urinary Incontinence
9%
Fever
9%
Radiation Recall Reaction (Dermatologic)
9%
Ear Pain
9%
Hypernatremia
9%
Anxiety
9%
Palmar-plantar Erythrodysesthesia Syndrome
9%
Lymphedema
9%
Pneumonitis
9%
Hypoglycemia
9%
Bloating
9%
Mucositis Oral
9%
Bullous Dermatitis
9%
Pruritus
9%
Sinus Bradycardia
9%
Gastroesophageal Reflux Disease
9%
Chills
9%
Lymphocyte Count Increase
9%
Hypercalcemia
9%
Arthralgia
9%
Chest Wall Pain
9%
Sinus Pain
9%
Hoarseness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort -1 (250mg BYL719, 3.6mg/kg T-DM1)
Cohort 1 (300mg BYL719, 3.6mg/kg T-DM1)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (PI3K inhibitor BYL719, letrozole)Experimental Treatment4 Interventions
Patients receive PI3K inhibitor BYL719 PO QD and letrozole PO QD. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PI3K inhibitor BYL719
2014
Completed Phase 1
~20
letrozole
1998
Completed Phase 3
~16660
Find a Location
Who is running the clinical trial?
Vanderbilt-Ingram Cancer CenterLead Sponsor
213 Previous Clinical Trials
60,887 Total Patients Enrolled
28 Trials studying Breast Cancer
6,594 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,930,325 Total Patients Enrolled
941 Trials studying Breast Cancer
1,543,396 Patients Enrolled for Breast Cancer
Ingrid MayerPrincipal InvestigatorVanderbilt-Ingram Cancer Center
2 Previous Clinical Trials
511 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had radiation therapy more than 2 weeks ago and have recovered from its side effects.I stopped hormone therapy over 2 weeks ago and have no major side effects except for hair loss.I have not had a period for at least 6 months due to radiation treatment.I am not using hormone therapy to suppress my ovaries.My breast cancer has come back in the same area and can be surgically removed.I have a condition that significantly affects my digestion.I have diabetes or had gestational diabetes.I am not taking medication that affects liver enzyme levels.I am on medication that affects my heart's rhythm and cannot change it.I have severe heart failure symptoms.I have received hormone therapy for my breast cancer that has spread.I have tissue samples from my cancer diagnosis available for study.My blood, liver, and kidney functions are all within normal ranges.I am fully active or can carry out light work.I have had both of my ovaries removed.I can swallow and keep down pills.I have not taken any herbal medications in the last 2 weeks.I do not have serious heart rhythm problems.I have a history of abnormal heart rhythms.I have brain metastases but have been stable for over 4 weeks after radiation.I haven't had a heart attack or any heart procedures in the last 6 months.I have a history of chronic liver or kidney failure.My breast cancer is stage IV, ER/PR positive, and HER2 negative.My liver function tests are within acceptable limits, even with liver metastasis.I have moderate to severe diarrhea.I stopped my cancer treatment 4 weeks ago and have recovered from its side effects.I have been treated with a PI3K inhibitor before.I am post-menopausal.My cancer has a PIK3CA mutation.I am currently on IV antibiotics for an infection.I have severe lung problems and need oxygen therapy.My blood pressure is controlled and below 180/110 mm Hg.I do not have any severe illnesses that are not under control.My calcium, potassium, or magnesium levels are not normal and can't be corrected.I am under 55 and have not had a period for 12 months or my hormone levels indicate menopause.I am 55 years old or older.I am 18 years old or older.I have a history of pancreatitis.My family has a history of long QT syndrome.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (PI3K inhibitor BYL719, letrozole)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the participant count for this research endeavor?
"This clinical trial is not accepting applications at this time. It was initially posted on April 1st 2013 and last modified on October 14th 2022. For those looking for other trials, there are presently 2298 studies recruiting patients with carcinoma breast stage IV and 181 trials admitting participants to test PI3K inhibitor BYL719."
Answered by AI
Are there any prior research studies relating to the effectiveness of BYL719 as a PI3K inhibitor?
"BYL719, a PI3K inhibitor, was first studied at the NIH Clinical Center in 1995. Since then it has been trialled 998 times and currently 181 clinical trials are actively recruiting patients; Nashville is home to many of these studies."
Answered by AI
Has the Food and Drug Administration authorized the use of BYL719 as a PI3K inhibitor?
"With limited data regarding its safety and efficacy, the Power team has assigned BYL719 a score of 1 on their scale from 1 to 3."
Answered by AI
To what ailment is BYL719, a PI3K inhibitor, typically prescribed?
"BYL719, a PI3K inhibitor medication, is useful for treating breast cancer and other medical conditions such as anovulatory cycle, tamoxifen resistance in postmenopausal women."
Answered by AI
Is there still an opportunity to participate in this research initiative?
"This clinical trial has now concluded; first posted on April 1st 2013 and last edited on October 14th 2022. If you are searching for alternative studies, there are currently 2298 trials recruiting patients with carcinoma breast stage IV and 181 studies utilizing PI3K inhibitor BYL719 actively enrolling participants."
Answered by AI
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