deltatrials
Terminated PHASE2 INTERVENTIONAL 3-arm NCT01919229

A Pharmacodynamics Pre-surgical Study of LEE011 in Early Breast Cancer Patients (MONALEESA-1) (MONALEESA-1)

A Randomized Pre-surgical Pharmacodynamics Study to Assess the Biological Activity of LEE011 Plus Letrozole Versus Single Agent Letrozole in Primary Breast Cancer

Sponsor: Novartis Pharmaceuticals

Conditions Early Breast Cancer
Interventions LEE011 (ribociclib) letrozole
Updated 6 times since 2017 Last updated: Nov 30, 2015 Started: Oct 31, 2013 Primary completion: Sep 30, 2014 Completion: Sep 30, 2014
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Due to low recruitment, it was decided to terminate the study.

Other terminated trials from Novartis Pharmaceuticals

See all terminations from Novartis Pharmaceuticals

This PHASE2 trial investigates Early Breast Cancer and is currently terminated or withdrawn. Novartis Pharmaceuticals leads this study, which shows 6 recorded versions since 2013 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotTerminated~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotTerminated~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotTerminated~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 24 months · monthly snapshotTerminated

Change History

6 versions recorded

  1. Sep 2024 — Present [monthly]

    Terminated PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE2

  3. Jan 2021 — Jul 2024 [monthly]

    Terminated PHASE2

  4. Jun 2018 — Jan 2021 [monthly]

    Terminated PHASE2

  5. Feb 2017 — Jun 2018 [monthly]

    Terminated PHASE2

▶ Show 1 earlier version

  1. Jan 2017 — Feb 2017 [monthly]

    Terminated PHASE2

    First recorded

Oct 2013

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Novartis Pharmaceuticals
Data source: Novartis

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations