A Pharmacodynamics Pre-surgical Study of LEE011 in Early Breast Cancer Patients (MONALEESA-1)
Public ClinicalTrials.gov record NCT01919229. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Pre-surgical Pharmacodynamics Study to Assess the Biological Activity of LEE011 Plus Letrozole Versus Single Agent Letrozole in Primary Breast Cancer
Study identification
- NCT ID
- NCT01919229
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Novartis Pharmaceuticals
- Industry
- Enrollment
- 14 participants
Conditions and interventions
Conditions
Interventions
- LEE011 (ribociclib) Drug
- letrozole Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2013
- Primary completion
- Aug 31, 2014
- Completion
- Aug 31, 2014
- Last update posted
- Dec 31, 2015
2013 – 2014
United States locations
- U.S. sites
- 4
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Highlands Oncology Group SC | Fayetteville | Arkansas | 72703 | — |
| University of California at Los Angeles UCLA SC | Los Angeles | California | 90095 | — |
| Massachusetts General Hospital SC-9 | Boston | Massachusetts | 02114 | — |
| University of Texas/MD Anderson Cancer Center Dept of MD Anderson (8) | Houston | Texas | 77030-4009 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01919229, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 31, 2015 · Synced May 16, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01919229 live on ClinicalTrials.gov.