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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

Must not have

Patient has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to enrollment, and who has not recovered to grade 1 or better from related side effects of such therapy

Subjects with unresolved osteonecrosis of the jaw

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

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My advanced breast cancer is HER2-negative.

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My advanced breast cancer is estrogen and/or progesterone receptor positive.

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My breast cancer cannot be cured and has spread or come back.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had recent radiation therapy and still experience side effects.

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I have ongoing jawbone issues not yet healed.

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I am allergic to alpelisib, fulvestrant, letrozole, goserelin, leuprolide, or their ingredients.

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I have been treated with PI3K inhibitors before.

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I have been diagnosed with type I diabetes or my type II diabetes is not under control.

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My liver is severely impaired.

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I am currently being treated for active lung inflammation.

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I have had acute pancreatitis in the last year or have chronic pancreatitis.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of first documented response to first documented progression or death, up to 33.3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Core Phase: Percentage of Participants Who Were Alive Without Disease Progression at 6 Months

Secondary study objectives

Core Phase: Clinical Benefit Rate (CBR)

Core Phase: Duration of Response (DOR)

Core Phase: Overall Response Rate (ORR)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~19040

Alpelisib

2018

Completed Phase 3

~960