Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer.(MONALEESA-2) (MONALEESA-2)
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| ClinicalTrials.gov Identifier: NCT01958021 |
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Recruitment Status :
Completed
First Posted : October 8, 2013
Results First Posted : May 12, 2017
Last Update Posted : April 26, 2023
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
- Study Details
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Advanced, Metastatic Breast Cancer |
| Interventions |
Drug: LEE011 Drug: Letrozole Drug: LEE011 Placebo |
| Enrollment | 668 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details | Six-hundred and sixty-eight patients were randomized; 334 patients each to the ribociclib plus letrozole arm and the placebo plus letrozole arm. Four patients who were randomized to the placebo plus letrozole arm did not receive study treatment; three due to physician's decision and one due to subject/guardian decision. |
| Arm/Group Title | LEE011 + Letrozole | Placebo + Letrozole |
|---|---|---|
 Arm/Group Description |
LEE011 (ribociclib) oral (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 QD + 2.5 mg letrozole QD | Matching ribociclib placebo, control drug administered orally (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 placebo QD + 2.5 mg letrozole |
| Period Title: Overall Study | ||
| Started | 334 | 334 |
| Patients Untreated | 0 | 4 |
| Patients Treated | 334 | 330 |
| Completed | 195 [1] | 154 [1] |
| Not Completed | 139 | 180 |
| Reason Not Completed | ||
| Progressive disease | 87 | 146 |
| Adverse Event | 25 | 7 |
| Subject/guardian decision | 12 | 13 |
| Physician Decision | 10 | 13 |
| Protocol Violation | 3 | 1 |
| Death | 2 | 0 |
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[1]
Completed = Treatment ongoing
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Baseline Characteristics
| Arm/Group Title | LEE011 + Letrozole | Placebo + Letrozole | Total | |
|---|---|---|---|---|
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Arm/Group Description |
LEE011 (ribociclib) oral (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 QD + 2.5 mg letrozole QD | Matching ribociclib placebo, control drug administered orally (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 placebo QD + 2.5 mg letrozole | Total of all reporting groups | |
| Overall Number of Baseline Participants | 334 | 334 | 668 | |
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Baseline Analysis Population Description |
The Full Analysis Set (FAS-population) consisted of all randomized patients.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 334 participants | 334 participants | 668 participants | |
| 61.4 (10.98) | 61.9 (10.52) | 61.6 (10.75) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 334 participants | 334 participants | 668 participants | |
| Female |
334 100.0%
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334 100.0%
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668 100.0%
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| Male |
0 0.0%
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0 0.0%
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0 0.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
Four patients who were randomized to the placebo plus letrozole arm did not receive study treatment and so are not part of the Safety Set.
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
| Name/Title: | Study Director |
| Organization: | Novartis Pharmaceuticals |
| Phone: | 862-778-8300 |
| EMail: | trialandresults.registries@novartis.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01958021 |
| Other Study ID Numbers: |
CLEE011A2301 2013-003084-61 ( EudraCT Number ) |
| First Submitted: | October 4, 2013 |
| First Posted: | October 8, 2013 |
| Results First Submitted: | April 4, 2017 |
| Results First Posted: | May 12, 2017 |
| Last Update Posted: | April 26, 2023 |