Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer. (MONALEESA-3)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02422615 |
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Recruitment Status :
Completed
First Posted : April 21, 2015
Results First Posted : September 19, 2018
Last Update Posted : May 23, 2023
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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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 Breast Cancer |
| Interventions |
Drug: Ribociclib Drug: fulvestrant Drug: Ribociclib placebo |
| Enrollment | 726 |
Participant Flow
| Recruitment Details | A total of 660 patients were planned and 726 patients were randomized in a ratio of 2:1 with 484 patients in the ribociclib plus fulvestrant arm and 242 patients in the placebo plus fulvestrant arm. |
| Pre-assignment Details |
| Arm/Group Title | Ribociclib + Fulvestrant | Ribociclib Placebo + Fulvestrant |
|---|---|---|
 Arm/Group Description |
Ribociclib 600mg daily oral (days 1 to 21 in a 28-day Cycle) in combination with fulvestrant 500mg i.m. injections every 28 days (Cycle n Day 1) with 1 additional dose on Day 15 of Cycle 1 | Ribociclib placebo 600mg daily oral (days 1 to 21 in a 28-day Cycle) in combination with fulvestrant 500mg i.m. injections every 28 days (Cycle n Day 1) with 1 additional dose on Day 15 of Cycle 1 |
| Period Title: Overall Study | ||
| Started | 484 | 242 |
| Untreated | 1 | 1 |
| Completed [1] | 204 | 76 |
| Not Completed | 280 | 166 |
| Reason Not Completed | ||
| Progressive disease | 193 | 142 |
| Adverse Event | 41 | 10 |
| Physician Decision | 22 | 7 |
| Subject/guardian decision | 21 | 5 |
| Death | 2 | 0 |
| Protocol Violation | 1 | 1 |
| Technical problems | 0 | 1 |
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[1]
Completed = Treatment ongoing at the time of the cut-off 3-Nov-2017.
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Baseline Characteristics
| Arm/Group Title | Ribociclib + Fulvestrant | Ribociclib Placebo + Fulvestrant | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Ribociclib 600mg daily oral (days 1 to 21 in a 28-day Cycle) in combination with fulvestrant 500mg i.m. injections every 28 days (Cycle n Day 1) with 1 additional dose on Day 15 of Cycle 1 | Ribociclib placebo 600mg daily oral (days 1 to 21 in a 28-day Cycle) in combination with fulvestrant 500mg i.m. injections every 28 days (Cycle n Day 1) with 1 additional dose on Day 15 of Cycle 1 | Total of all reporting groups | |
| Overall Number of Baseline Participants | 484 | 242 | 726 | |
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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 | 484 participants | 242 participants | 726 participants | |
| 63.4 (9.78) | 62.8 (10.59) | 63.2 (10.05) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 484 participants | 242 participants | 726 participants | |
| Female |
484 100.0%
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242 100.0%
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726 100.0%
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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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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 484 participants | 242 participants | 726 participants |
| Caucasian |
406 83.9%
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213 88.0%
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619 85.3%
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| Asian |
45 9.3%
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18 7.4%
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63 8.7%
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| Native American |
5 1.0%
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1 0.4%
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6 0.8%
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| Black |
3 0.6%
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2 0.8%
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5 0.7%
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| Other |
10 2.1%
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3 1.2%
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13 1.8%
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| Unkown |
15 3.1%
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5 2.1%
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20 2.8%
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Outcome Measures
Adverse Events
Limitations and Caveats
One patient from each arm did not receive study treatment and so there two patients 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: | novartis.email@novartis.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT02422615 |
| Other Study ID Numbers: |
CLEE011F2301 2015-000617-43 ( EudraCT Number ) |
| First Submitted: | April 1, 2015 |
| First Posted: | April 21, 2015 |
| Results First Submitted: | August 18, 2018 |
| Results First Posted: | September 19, 2018 |
| Last Update Posted: | May 23, 2023 |