Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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

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. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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
Novartis Pharmaceuticals

1,375 total trials

What the registry record for NCT01872260 still lists

NCT01872260 is an interventional study that assigns participants to a tested intervention. The registered 255 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (91% lower).

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 names 20 study sites across 12 states, led by 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.

Learn More About Clinical Trials

Similar trials for Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01872260's enrollment target sits among peer trials

255 319th of 1224 higher than 906 of 1,224 other Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT04623424 · 255 participants

    Intestinal Microbiota in Stem Cell Transplant Transplant Admission

  • NCT05114798 · 255 participants · NA

    Time-restricted Eating Versus Daily Continuous Calorie Restriction on Body Weight and Colorectal Cancer Risk Markers

  • NCT05336188 · 255 participants · Phase 2

    Neurocognitive Mechanisms Underlying Smartphone-Assisted Prevention of Relapse in Opioid Use Disorder

  • NCT05486637 · 255 participants · Early Phase 1

    Vocal Emotion Communication With Cochlear Implants

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Related registry views

Source: ClinicalTrials.gov NCT01872260, the US trial registry maintained by the National Library of Medicine. NCT01872260 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.