Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01958021 · ClinicalTrials.gov registry record · Phase 3
Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 668
- Enrollment target
NCT01958021: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01958021 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 668 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01958021, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 668 participants
- Enrollment target
Study Summary
The primary purpose of this study was to assess the efficacy of ribociclib, as measured by progression free survival (PFS), in postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who received no prior treatment for advanced disease.
Primary Outcome
PFS was defined as the period starting from the date of randomization to the date of the first documented progression or death caused by any reason. In cases where patients did not experience an event, the PFS was censored at the date of the last adequate tumor assessment. Clinical deterioration without objective radiological evidence was not considered as documented disease progression.PFS was assessed by investigator assessment according to RECIST 1.1. The Kaplan-Meier method was used to estim
Interventions
- DRUG Placebo
- DRUG Letrozole
- DRUG Ribociclib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 668 participants |
| Start Date | 2013-12-17 |
| Est. Completion | 2023-03-16 |
| Phase | Phase 3 |
What the finished NCT01958021 record still lists
NCT01958021 is an interventional study that assigns participants to a tested intervention. The registered 668 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01958021 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01958021 about?
NCT01958021 is a clinical study titled "Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer". The primary purpose of this study was to assess the efficacy of ribociclib, as measured by progression free survival (PFS), in postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who received no prior treatment f...
What is the current status of trial NCT01958021?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 668 participants. The study started on 2013-12-17. Estimated completion is 2023-03-16.
What interventions are being tested in trial NCT01958021?
The interventions under investigation include: Placebo (DRUG), Letrozole (DRUG), Ribociclib (DRUG).
Who is sponsoring clinical trial NCT01958021?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01958021's enrollment target sits among peer trials
668 548th of 2000 higher than 1,450 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
- NCT04155034 · 668 participants · Phase 3
S1827 (MAVERICK) Testing Whether the Use of Brain Scans Alone Instead of Brain Scans Plus Preventive Brain Radiation Affects Lifespan in Patients With Small Cell Lung Cancer
- NCT04179981 · 668 participants · NA
Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Obstructive Pulmonary Disease and Comorbid Obstructive Sleep Apnea (Overlap Syndrome)
- NCT05006482 · 668 participants · Phase 3
Geriatric Evaluation and Management With Survivorship Health Education for Older Survivors of Cancer, GEM-S Trial
- NCT02984761 · 670 participants · NA
Veterans Affairs Lung Cancer Surgery Or Stereotactic Radiotherapy
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