Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer (MONALEESA-7)
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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: NCT02278120 |
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Recruitment Status :
Active, not recruiting
First Posted : October 29, 2014
Results First Posted : February 26, 2019
Last Update Posted : April 25, 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 Metastatic Breast Cancer |
| Interventions |
Drug: LEE011 Drug: Tamoxifen Drug: Letrozole Drug: Anastrozole Drug: Goserelin Drug: LEE011 Placebo |
| Enrollment | 672 |
Participant Flow
| Recruitment Details | Approximately 660 patients were planned to be randomized in a 1:1 ratio to one of the following treatment arms: Ribociclib (LEE011) arm and Placebo arm. |
| Pre-assignment Details |
| Arm/Group Title | LEE011 + NSAI/Tamoxifen + Goserelin | LEE011 Placebo + NSAI/Tamoxifen+ Goserelin |
|---|---|---|
 Arm/Group Description |
LEE011 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days) | LEE011 Placebo 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days) |
| Period Title: Overall Study | ||
| Started | 335 | 337 |
| Completed [1] | 174 | 121 |
| Not Completed | 161 | 216 |
| Reason Not Completed | ||
| Progressive disease | 122 | 174 |
| Patient/guardian decision | 14 | 8 |
| Adverse Event | 12 | 10 |
| Physician Decision | 8 | 19 |
| Death | 3 | 3 |
| Lost to Follow-up | 2 | 0 |
| Protocol Violation | 0 | 2 |
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[1]
Completed = Treatment ongoing at time of data cut-off, 20-Aug-2017
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Baseline Characteristics
| Arm/Group Title | LEE011 + NSAI/Tamoxifen + Goserelin | LEE011 Placebo + NSAI/Tamoxifen+ Goserelin | Total | |
|---|---|---|---|---|
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Arm/Group Description |
LEE011 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days) | LEE011 Placebo 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days) | Total of all reporting groups | |
| Overall Number of Baseline Participants | 335 | 337 | 672 | |
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Baseline Analysis Population Description |
Full Analysis Set (FAS): All randomized patients were included in the FAS (intent-to-treat population).
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 335 participants | 337 participants | 672 participants | |
| 42.6 (6.6) | 43.7 (6.17) | 43.1 (6.4) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 335 participants | 337 participants | 672 participants | |
| Female |
335 100.0%
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337 100.0%
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672 100.0%
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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: Number Unit of measure: Participants |
Number Analyzed | 335 participants | 337 participants | 672 participants |
| Caucasian | 187 | 201 | 388 | |
| Asian | 99 | 99 | 198 | |
| Black | 10 | 9 | 19 | |
| Native American | 3 | 3 | 6 | |
| Other | 16 | 7 | 23 | |
| Unknown | 20 | 18 | 38 | |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
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: | Clinical Disclosure Office |
| 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: | NCT02278120 |
| Other Study ID Numbers: |
CLEE011E2301 2014-001931-36 ( EudraCT Number ) |
| First Submitted: | October 22, 2014 |
| First Posted: | October 29, 2014 |
| Results First Submitted: | August 17, 2018 |
| Results First Posted: | February 26, 2019 |
| Last Update Posted: | April 25, 2023 |