ClinicalTrials.gov record
Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer
ClinicalTrials.gov ID: NCT01958021
Public ClinicalTrials.gov record NCT01958021. 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.
ClinicalTrials.gov public records Last synced May 12, 2026, 3:37 PM EDT
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 Double-blind, Placebo-controlled Study of LEE011 in Combination With Letrozole for the Treatment of Postmenopausal Women With Hormone Receptor Positive, HER2 Negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease
Study identification
- NCT ID
- NCT01958021
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Novartis Pharmaceuticals
- Industry
- Enrollment
- 668 participants
Conditions and interventions
Conditions
Interventions
- Letrozole Drug
- Placebo Drug
- Ribociclib Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 100 Years
- 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
- Dec 16, 2013
- Primary completion
- Jan 28, 2016
- Completion
- Mar 15, 2023
- Last update posted
- Mar 6, 2025
2013 – 2023
United States locations
- U.S. sites
- 73
- U.S. states
- 28
- U.S. cities
- 65
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ironwood Cancer and Research Centers | Chandler | Arizona | 85224 | — |
| Arizona Oncology Associates PC HAL | Sedona | Arizona | 86336 | — |
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | — |
| NEA Baptist Cancer Center | Jonesboro | Arkansas | 72401 | — |
| Alta Bates Cancer Center | Berkeley | California | 94704 | — |
| City of Hope National Medical Center | Duarte | California | 91010 3000 | — |
| Glendale Adventist Medical Center | Glendale | California | 91206 | — |
| The Angeles Clinic and Research Institute | Los Angeles | California | 90025 | — |
| Cedars Sinai Medical Center SC-5 | Los Angeles | California | 90048 | — |
| Comprehensive Cancer Center | Sacramento | California | 95817 | — |
| Univ of Colorado School of Medicine | Aurora | Colorado | 80045 | — |
| Rocky Mountain Cancer Centers | Longmont | Colorado | 80501 | — |
| University Cancer Institute | Boynton Beach | Florida | 33426 | — |
| Florida Cancer Research Institute | Davie | Florida | 33328 | — |
| Florida Cancer Specialists | Fort Myers | Florida | 33901 | — |
| Memorial Hospital | Hollywood | Florida | 33021 | — |
| University Of Miami | Miami | Florida | 33136 | — |
| Florida Retina Institute | Orlando | Florida | 32804 | — |
| Sacred Heart Medical Oncology | Pensacola | Florida | 32504 | — |
| Florida Cancer Specialists-North | St. Petersburg | Florida | 33705 | — |
| Georgia Cancer Specialists | Decatur | Georgia | 30033 | — |
| Lewis Hall Singletary Onc Ctr at John D. Archbold Mem Hosp. | Thomasville | Georgia | 31792 | — |
| Moanalua Medical Center Attn Oncology Dept | Honolulu | Hawaii | 96817 | — |
| University of Illinois Cancer Center at Chicago | Chicago | Illinois | 60612 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| NorthShore University Health System | Evanston | Illinois | 60201 | — |
| Ingalls Memorial Hospital | Harvey | Illinois | 60426 | — |
| Edward Hospital | Naperville | Illinois | 60540 | — |
| IU Simon Cancer Center | Indianapolis | Indiana | 46202 | — |
| Sidney Kimmel CCC At JH | Baltimore | Maryland | 21231 | — |
| Frederick Memorial Hospital | Frederick | Maryland | 21701 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Allina Hlth Cancer Inst Minneapolis | Minneapolis | Minnesota | 55407 | — |
| Jackson Oncology Associates | Jackson | Mississippi | 39202 | — |
| St Lukes Hos Marion Bloch Neur Inst | Kansas City | Missouri | 64111 | — |
| Mercy Medical Research Institute | Manchester | Missouri | 63021 | — |
| Foundation Medical Partners | Nashua | New Hampshire | 03060 | — |
| Cooper Cancer Center | Camden | New Jersey | 08103 | — |
| Hackensack Meridian Health | Edison | New Jersey | 88837 | — |
| Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | — |
| C R Wood Cancer Center at Glens Falls Hospital | Glens Falls | New York | 12801 | — |
| Winthrop University Hospital | Mineola | New York | 11501 | — |
| NYU Langone Med Center CV Research | New York | New York | 10016 | — |
| Mount Sinai School Of Medicine | New York | New York | 10029 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Duke Univ Medical Center | Durham | North Carolina | 27710 | — |
| Oncology Hematology Care Inc | Cincinnati | Ohio | 45242 | — |
| The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43221 | — |
| Mercy Clinic Oklahoma Communities Mercy Oncology | Oklahoma City | Oklahoma | 73120 | — |
| Lehigh Valley Hospital | Allentown | Pennsylvania | 18103 | — |
| Penn State Hershey Cancer Institute | Hershey | Pennsylvania | 17033 | — |
| Avera Cancer | Sioux Falls | South Dakota | 57105 | — |
| Chattanooga Onc And Hem Assoc PC | Chattanooga | Tennessee | 37404 | — |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | — |
| Vanderbilt University Medical Ctr | Nashville | Tennessee | 37232 | — |
| Texas Oncology P A | Bedford | Texas | 76022 | — |
| Texas Oncology | Dallas | Texas | 75251 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Ctr For Cancer And Blood Disorders | Fort Worth | Texas | 76104 | — |
| Texas Oncology P A | Fort Worth | Texas | 76104 | — |
| Texas Oncology Houston Memorial City | Houston | Texas | 77024 | — |
| Uni Of TX MD Anderson Cancer Cntr | Houston | Texas | 77030 | — |
| Millennium Research Clin Develop | Houston | Texas | 77090 | — |
| Texas Oncology | McAllen | Texas | 78503 | — |
| Richardson Hematology Oncology Associates | Richardson | Texas | 75082 | — |
| Texas Oncology P A | San Antonio | Texas | 78217 | — |
| Texas Oncology Northeast Texas | Tyler | Texas | 75702 | — |
| Utah Cancer Specialists | Salt Lake City | Utah | 84106 | — |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | — |
| Oncology and Hematology Associates of Southwest Virginia Inc | Salem | Virginia | 24153 | — |
| Providence Regional Cancer Partnership | Everett | Washington | 98201 | — |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | — |
| Dean Health System | Madison | Wisconsin | 53717 | — |
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 148 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01958021, 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 Mar 6, 2025 · Synced May 12, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01958021 live on ClinicalTrials.gov.