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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 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.

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

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

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 more

BYLieve 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

~18970

Alpelisib

2018

Completed Phase 3

~900

Fulvestrant

2011

Completed Phase 3

~3690

Letrozole

2002

Completed Phase 4

~3240

Goserelin

2008

Completed Phase 3

~7100

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,855 Previous Clinical Trials

4,196,971 Total Patients Enrolled

87 Trials studying Breast Cancer

37,433 Patients Enrolled for Breast Cancer

Media Library

Alpelisib (PI3K Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03056755 — Phase 2

Breast Cancer Research Study Groups: Cohort A: Pre-treated with CDK 4/6i + AI, Cohort B: Pre-treated with CDK 4/6i + fulvestrant, Cohort C: Pre-treated with systemic chemotherapy or ET

Breast Cancer Clinical Trial 2023: Alpelisib Highlights & Side Effects. Trial Name: NCT03056755 — Phase 2

Alpelisib (PI3K Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03056755 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cap for enrolment in this research project?

"Unfortunately, enrollment for this trial has been closed since November 10th 2022. However, if you are still looking to participate in a medical study related to breast cancer or alpelisib there are 2,600 and 342 clinical trials respectively that remain open for recruitment."

Answered by AI

Are there any available vacancies to participate in this trial?

"According to clinicaltrials.gov, this medical trial is no longer open for enrollment and has not been since November 10th 2022. Despite its closure, there are still 2,942 other trials that are actively recruiting individuals at this moment in time."

Answered by AI

Have any former studies investigated the impacts of alpelisib?

"As of now, alpelisib trials are ongoing in 342 separate studies with 95 at the Phase 3 level. Out of these experiments, Shanghai plays host to a large number yet there remains an impressive 20 932 other sites conducting research into this drug."

Answered by AI

What conditions is alpelisib primarily employed to treat?

"Alpelisib has its primary application in the treatment of stage t2b prostate cancer but can also provide relief for patients suffering from conditions such as tamoxifen, endometrioma and breast malignancies."

Answered by AI

What are the objectives of this clinical experiment?

"The primary objective of this research, to be assessed after 6 months, is the rate of individuals who remain alive without disease progression. Secondary aims involve measuring Progression Free Survival on next line treatment (PFS2), Overall Survival from start to finish of treatment or loss to follow-up, and Overall Response Rate as evaluated according to RECIST v1.1 standards in each group."

Answered by AI

To what extent can alpelisib endanger the health of users?

"The safety rating of alpelisib was determined to be a 2, since this is still an early-phase trial with some evidence backing its security but none attesting to its efficacy."

Answered by AI

How many distinct locations is the trial being conducted within?

"UT Health San Antonio in San Antonio, St Vincent Frontier Cancer Center in Billings, and Advent Health Cancer Institute are just a handful of the 29 medical centres enrolled for this trial."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

Alpelisib Plus Fulvestrant in Pik3ca-mutated, Hormone Receptor-positive Advanced Breast Cancer After a CDK4/6 Inhibitor (bylieve): One Cohort of a Phase 2, Multicentre, Open-label, Non-comparative Study

Rugo, Hope S, Florence Lerebours, Eva Ciruelos, Pamela Drullinsky, Manuel Ruiz-Borrego, Patrick Neven, Yeon Hee Park, et al.. 2021. “Alpelisib Plus Fulvestrant in Pik3ca-mutated, Hormone Receptor-positive Advanced Breast Cancer After a CDK4/6 Inhibitor (bylieve): One Cohort of a Phase 2, Multicentre, Open-label, Non-comparative Study”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(21)00034-6.

clinicaltrials.govStudy

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments

2017. "Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03056755.

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