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NCT01872260 · ClinicalTrials.gov registry record · Phase 1

Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer

A Phase 1 study of Breast Cancer, sponsored by Novartis Pharmaceuticals.

Active
Registry status
Phase 1
Development phase
255
Enrollment target
20
Study locations

NCT01872260 is a Phase 1 study of Breast Cancer that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 255 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT01872260, a Phase 1 study of Breast Cancer, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
255 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this trial is to inform the future clinical development of the two investigational agents in ER+ breast cancer, LEE011 (CDK4/6 inhibitor) and BYL719 (PI3K-alpha inhibitor). This is a multi-center, open-label Phase Ib study. The Phase Ib dose escalation will estimate the MTD and/or RP2D for three regimens: two double combinations, LEE011 with letrozole and BYL719 with letrozole, followed by triple combinations of LEE011 + BYL719 with letrozole (Arms 3 and 4). The Phase Ib dose escalation part will be followed by Phase Ib dose expansions to further characterize the safety, tolerability, PK and preliminary clinical anti-tumor activity of the combinations. Optional crossover for patients who have progressed while on dose escalation or dose expansion with doublet treatment on Arms 1 or 2 to be treated with the triplet combination (Arm 3) after the determination of the RP2D for Arm 3; is no longer permitted after protocol amendment 6. Approximately 270 adult women with ER+/HER2- locally advanced or metastatic breast cancer will be enrolled.

Conditions Studied

Breast Cancer

Interventions

  • DRUG Letrozole
  • DRUG LEE011
  • DRUG BYL719

Study Locations (20)

Other

  • Novartis Investigative Site - Marseille
  • Novartis Investigative Site - Paris
  • Novartis Investigative Site - Saint-Herblain
  • Novartis Investigative Site - Madrid
  • Novartis Investigative Site - Madrid

California

  • Univ of California at San Diego Moores Cancer Ctr - San Diego
  • UCSF Medical Center - San Francisco

Massachusetts

  • Massachusetts General Hospital SC-5 - Boston
  • Massachusetts General Hospital - Boston

Tennessee

  • Sarah Cannon Research Institute - Nashville
  • Vanderbilt University Medical Ctr - Nashville

Texas

  • Texas Oncology - Dallas
  • Mays Cancer Ctr Uthsa Mdacc - San Antonio

Florida

  • H Lee Moffitt Cancer Center and Research Institute - Tampa

Washington

  • Northwest Medical Specialties - Tacoma

New South Wales

  • Novartis Investigative Site - Westmead

Trial Details

FieldValue
Enrollment Target 255 participants
Start Date 2013-10-22
Est. Completion 2027-02-26
Phase Phase 1

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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What the Registry Record Tells You About NCT01872260

The ClinicalTrials.gov registry entry for NCT01872260 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 255 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (91% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Letrozole is the first listed.

NCT01872260 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Other, California, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT01872260 about?

NCT01872260 is a clinical study titled "Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer". The purpose of this trial is to inform the future clinical development of the two investigational agents in ER+ breast cancer, LEE011 (CDK4/6 inhibitor) and BYL719 (PI3K-alpha inhibitor). This is a multi-center, open-label Phase Ib study. The Phase Ib dose escalation will estimate the MTD and/or RP...

What is the current status of trial NCT01872260?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 255 participants. The study started on 2013-10-22. Estimated completion is 2027-02-26.

What conditions does trial NCT01872260 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT01872260?

The interventions under investigation include: Letrozole (DRUG), LEE011 (DRUG), BYL719 (DRUG).

Who is sponsoring clinical trial NCT01872260?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01872260 being conducted?

This trial has 20 study locations across California, Florida, Massachusetts, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.