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PI3K Inhibitor
Alpelisib + Enzalutamide for Breast Cancer
Phase 1
Waitlist Available
Led By Meghan Karuturi
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 28 days
Awards & highlights
Study Summary
This trial looks at side effects and best dose of alpelisib when given with enzalutamide to treat patients with androgen receptor and PTEN positive breast cancer.
Who is the study for?
This trial is for adults with metastatic breast cancer that's hormone-receptor positive or triple-negative, and not suitable for surgery/radiation. Participants must have stable health, meet specific blood/lab criteria, and not be pregnant or breastfeeding. They should agree to use effective contraception if of childbearing potential.Check my eligibility
What is being tested?
The trial tests the combination of Alpelisib and Enzalutamide in patients with advanced breast cancer. It aims to find the best dose while assessing side effects. Alpelisib blocks enzymes needed for tumor growth; Enzalutamide lowers body's androgen to combat cancer cell growth.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system, gastrointestinal issues affecting drug absorption, uncontrolled diabetes risks due to altered glucose levels, fatigue from anemia or other blood-related changes, liver function alterations, and possible skin sensitivity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 28 days
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 (MTD) of alpelisib in combination with enzalutamide
Secondary outcome measures
Clinical benefit rate (CBR) (complete response or partial response + prolonged stable disease)
Incidence of adverse events
Profession-free survival (PFS)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (alpelisib, enzalutamide)Experimental Treatment2 Interventions
Patients receive alpelisib PO and enzalutamide PO on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alpelisib
FDA approved
Enzalutamide
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,649 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,784 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
Meghan KaruturiPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
154 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- If you are a woman who could become pregnant, you must have a negative pregnancy test within a week before starting the study drug.You have a certain type of breast cancer that is either hormone-receptor positive or triple-negative.You meet specific requirements for blood cell counts, kidney function, liver function, and blood sugar levels.If you have cancer in your brain or spinal cord, it must meet certain conditions, including waiting at least 4 weeks after previous treatment, not having cancer in the fluid around the brain, and having breast cancer that cannot be treated with surgery or radiation at the time of screening.You have a stomach or intestinal condition that could affect how your body absorbs the study drug BYL719 when taken by mouth.For the first group, you have at least one measurable disease according to specific criteria. For the second group, you have a measurable disease that is larger than a certain size and can be biopsied.You have a tumor in your brain or spinal cord, or the cancer has spread to these areas.You are allergic to any of the ingredients in BYL719 or enzalutamide.Your diabetes is not under control.You have not fully recovered from side effects of previous cancer treatments.You have tested positive for HIV.The patient's tumor tests positive for AR and PTEN using specific laboratory tests.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (alpelisib, enzalutamide)
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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 prior investigations have been conducted on the effects of alpelisib and enzalutamide?
"Currently, 131 clinical trials on Treatment (alpelisib, enzalutamide) are running and 37 of those studies are in Phase 3. Most research is taking place at Germantown, Tennessee; however there exists a total of 7051 locations conducting investigations into this treatment."
Answered by AI
Is there still opportunity for people to join the study?
"That is correct. According to clinicaltrials.gov, the trial which originated on June 7th 2019 is actively seeking out applicants and has recently been updated as of December 5th 2022. 28 individuals must be recruited from one medical site."
Answered by AI
What are the safety concerns associated with alpelisib and enzalutamide treatment?
"With limited prior data to vouch for it, Treatment (alpelisib and enzalutamide) was given a score of 1 in terms of safety. After all, this is still an early phase trial that has yet to prove its efficacy or safety."
Answered by AI
How many participants have been enrolled in this clinical experiment?
"Affirmative. According to the data published on clinicaltrials.gov, this medical study is currently recruiting participants and was first made available online on June 7th 2019. The protocol calls for 28 individuals from a single location and has been revised as recently as December 5th 2022."
Answered by AI
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