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PI3K-alpha Inhibitor

LEE011 + BYL719 + Letrozole for Breast Cancer

Phase 1 & 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
Postmenopausal, Estrogen-receptor positive and/or Progesterone-receptor positive breast cancer
Be older than 18 years old
Must not have
HER2-overexpression in the patient's tumor tissue
Acute or chronic pancreatitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up average 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will help researchers learn more about how effective and safe two investigational agents are in treating ER+ breast cancer.

Who is the study for?
This trial is for postmenopausal women with advanced ER+/HER2- breast cancer who haven't had systemic treatment in the advanced setting, except possibly letrozole for up to one month. They can have had (neo)adjuvant therapy if they've been disease-free for over a year since completion. Exclusions include recent major surgery, other cancers within 3 years, heart issues, active brain metastases, and certain diabetes conditions.
What is being tested?
The study tests two drugs: LEE011 (a CDK4/6 inhibitor) and BYL719 (a PI3K-alpha inhibitor), both combined with letrozole. It's an open-label Phase Ib trial aiming to find the maximum tolerated doses of these combinations and their preliminary effectiveness against breast cancer.
What are the potential side effects?
Potential side effects may include reactions related to hormone changes due to letrozole use, as well as possible organ-specific inflammation or dysfunction from LEE011 or BYL719. The exact side effects will be further characterized during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am postmenopausal with hormone-receptor positive breast cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My tumor has high levels of HER2.
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I have pancreatitis.
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I am on hormone replacement therapy that I cannot stop.
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My heart does not function properly.
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I have active brain metastases.
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I have not had another cancer in the last 3 years.
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My cancer has spread throughout both lungs.
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I have not had major surgery in the last 2 weeks.
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I have diabetes or had gestational diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~average 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and average 24 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
PK profiles of LEE011 and letrozole
Safety and tolerability
Secondary study objectives
Duration of Response (DOR)
Overall Response Rate (ORR)
Pharmacokinetics (PK) parameters, including but not limited to AUCtau, Cmin, Cmax, Tmax, accumulation ratio (Racc)
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: LEE011+ BYL719+letrozole Arm 4Experimental Treatment3 Interventions
LEE011-daily (dose escalating), BYL719 -daily (dose escalating), letrozole 2.5 mg/day
Group II: LEE011 + letrozole Arm 1Experimental Treatment2 Interventions
LEE011 - 28 day cycles (21 days followed by a 7 day break - dose escalating), letrozole - 2.5 mg/day
Group III: LEE011 + BYL719 + letrozole Arm 3Experimental Treatment3 Interventions
LEE011 - 28 day cycles (21 days followed by a 7 day break -dose escalating), BYL719 - daily (dose escalating), letrozole 2.5 mg/day
Group IV: BYL719 + letrozole Arm 2Experimental Treatment2 Interventions
BYL719 - daily (dose escalating) letrozole - 2.5 mg/day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LEE011
2014
Completed Phase 3
~1960
Letrozole
2002
Completed Phase 4
~3590
BYL719
2013
Completed Phase 2
~1230

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,920 Previous Clinical Trials
4,254,431 Total Patients Enrolled
87 Trials studying Breast Cancer
37,500 Patients Enrolled for Breast Cancer

Media Library

BYL719 (PI3K-alpha Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01872260 — Phase 1 & 2
Breast Cancer Research Study Groups: LEE011 + letrozole Arm 1, BYL719 + letrozole Arm 2, LEE011 + BYL719 + letrozole Arm 3, LEE011+ BYL719+letrozole Arm 4
Breast Cancer Clinical Trial 2023: BYL719 Highlights & Side Effects. Trial Name: NCT01872260 — Phase 1 & 2
BYL719 (PI3K-alpha Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01872260 — Phase 1 & 2
~11 spots leftby Jun 2025
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