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PI3K Inhibitor
Alpelisib + Hormone Therapy for Advanced Breast Cancer (BYLieve Trial)
Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient has confirmed HER2-negative advanced breast cancer (aBC)
Patient has histological and/or cytological confirmed ER+ and/or PgR+ aBC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of first documented response to first documented progression or death, up to 33.3 months
Awards & highlights
BYLieve Trial Summary
This trial is testing a new combination of drugs for breast cancer that has progressed after other treatments. The new drugs are alpelisib and fulvestrant or letrozole.
Who is the study for?
This trial is for adults with hormone receptor-positive, HER2-negative advanced breast cancer with PIK3CA mutations. It includes both premenopausal and postmenopausal women, as well as men not eligible for curative therapy. Participants must have progressed after prior treatments but can't have more than two previous anti-cancer therapies or severe diabetes, liver impairment, active lung disease, or a history of certain severe skin reactions.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of alpelisib combined with either fulvestrant or letrozole in patients who've had different prior endocrine therapies. The choice between fulvestrant and letrozole depends on the patient's menopausal status and previous treatments.See study design
What are the potential side effects?
Potential side effects include high blood sugar levels which could be problematic for diabetics; gastrointestinal issues that might affect drug absorption; possible inflammation of the lungs; pancreatitis; severe skin reactions to medication components; and complications from other concurrent cancers.
BYLieve Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My advanced breast cancer is HER2-negative.
Select...
My advanced breast cancer is estrogen and/or progesterone receptor positive.
Select...
My breast cancer cannot be cured and has spread or come back.
BYLieve Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of first documented response to first documented progression or death, up to 33.3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of first documented response to first documented progression or death, up to 33.3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Core Phase: Percentage of Participants Who Were Alive Without Disease Progression at 6 Months
Secondary outcome measures
Core Phase: Clinical Benefit Rate (CBR)
Core Phase: Duration of Response (DOR)
Core Phase: Overall Response Rate (ORR)
+4 moreBYLieve Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort C: Pre-treated with systemic chemotherapy or ETExperimental Treatment4 Interventions
Participants who received systemic chemotherapy or endocrine therapy (ET) (as monotherapy or in combination with targeted treatment except CDK 4/6i + AI) as immediate prior treatment will receive alpelisib + fulvestrant.
Group II: Cohort B: Pre-treated with CDK 4/6i + fulvestrantExperimental Treatment4 Interventions
Patients who received any CDK 4/6i plus fulvestrant as immediate prior treatment will receive alpelisib + letrozole
Group III: Cohort A: Pre-treated with CDK 4/6i + AIExperimental Treatment4 Interventions
Participants who received any Cyclin-Dependent Kinases 4 and 6 inhibitor (CDK 4/6i) plus aromatase inhibitor (AI) as immediate prior treatment will receive alpelisib + fulvestrant
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leuprolide
2008
Completed Phase 4
~19000
Alpelisib
2018
Completed Phase 3
~900
Fulvestrant
2011
Completed Phase 3
~3690
Letrozole
2002
Completed Phase 4
~2770
Goserelin
2008
Completed Phase 3
~4110
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,866 Previous Clinical Trials
4,198,947 Total Patients Enrolled
87 Trials studying Breast Cancer
37,439 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My advanced breast cancer is HER2-negative.I had recent radiation therapy and still experience side effects.I have ongoing jawbone issues not yet healed.I am a woman of any menopausal status eligible for a study involving LHRH agonist with alpelisib and letrozole/fulvestrant.I am under 60, taking tamoxifen or toremifene, and my hormone levels indicate I am post-menopausal.I am 18 years old or older.I am premenopausal based on my recent menstrual history or hormone levels.My cancer has a PIK3CA mutation confirmed by a certified lab.I am allergic to alpelisib, fulvestrant, letrozole, goserelin, leuprolide, or their ingredients.I have been treated with PI3K inhibitors before.I have been diagnosed with type I diabetes or my type II diabetes is not under control.My brain tumor is stable, and I haven't had brain treatment in the last 4 weeks.My liver is severely impaired.I am currently being treated for active lung inflammation.I am not currently using any other anti-cancer treatments.I am a postmenopausal woman, meeting one of the specified conditions.I am monitoring my menopause status with hormone tests due to treatment-induced amenorrhea.You have received specific treatments for your cancer, not too many prior treatments, and you meet certain health criteria.I haven't had cancer, except for certain skin cancers or treated cervical cancer, in the last 3 years.My advanced breast cancer is estrogen and/or progesterone receptor positive.I have a digestive condition that affects how my body absorbs medication.My breast cancer cannot be cured and has spread or come back.I have had acute pancreatitis in the last year or have chronic pancreatitis.You have had serious skin reactions like Stevens-Johnson Syndrome, Erythema Multiforme, Toxic Epidermal Necrolysis, or Drug Reaction with Eosinophilia and Systemic Symptoms in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A: Pre-treated with CDK 4/6i + AI
- Group 2: Cohort B: Pre-treated with CDK 4/6i + fulvestrant
- Group 3: Cohort C: Pre-treated with systemic chemotherapy or ET
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.
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