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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 16 weeks
Awards & highlights
Summary
This trial tests the combination of alpelisib and enzalutamide in patients with advanced breast cancer that has specific markers. The drugs work together to block cancer cell growth and reduce hormone levels, aiming to improve treatment outcomes. Alpelisib is a unique drug approved for the treatment of patients with estrogen receptor-positive metastatic 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.
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.
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 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 16 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Alpelisib, a PI3K inhibitor, targets the PI3K/AKT/mTOR pathway to reduce tumor cell proliferation and induce apoptosis, while Enzalutamide, an androgen receptor inhibitor, blocks androgens that promote cancer cell growth. These targeted therapies are crucial for breast cancer patients as they offer more effective treatment options based on the specific molecular characteristics of their tumors.
Breast Cancer Resistance to Cyclin-Dependent Kinases 4/6 Inhibitors: Intricacy of the Molecular Mechanisms.PIK3CA and MAP3K1 alterations imply luminal A status and are associated with clinical benefit from pan-PI3K inhibitor buparlisib and letrozole in ER+ metastatic breast cancer.Endocrine therapy for early breast cancer.
Breast Cancer Resistance to Cyclin-Dependent Kinases 4/6 Inhibitors: Intricacy of the Molecular Mechanisms.PIK3CA and MAP3K1 alterations imply luminal A status and are associated with clinical benefit from pan-PI3K inhibitor buparlisib and letrozole in ER+ metastatic breast cancer.Endocrine therapy for early breast cancer.
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,683 Total Patients Enrolled
148 Trials studying Breast Cancer
63,277 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,982 Total Patients Enrolled
945 Trials studying Breast Cancer
1,543,964 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:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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.
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