Phase 3
Completed N=668
Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer
Advanced, Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT01958021 ↗
Enrolled (actual)
668
Serious AEs
25.6%
Results posted
May 2017
Primary outcomePrimary: Progression Free Survival (PFS) by Investigator Assessment — NA; 14.7 months — p=0.00000329
◆ Published Evidence
Highly cited
703citations · ~176 / year
Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer.
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.
Linked Publications (5)
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Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer.
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Pooled ctDNA analysis of MONALEESA phase III advanced breast cancer trials.
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Matching-adjusted indirect comparison of PFS and OS comparing ribociclib plus letrozole <i>versus</i> palbociclib plus letrozole as first-line treatment of HR+/HER2- advanced breast cancer.
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Quality of life with ribociclib <i>versus</i> abemaciclib as first-line treatment of HR+/HER2- advanced breast cancer: a matching-adjusted indirect comparison.
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Justifying Ribociclib Dose in Patients with Advanced Breast Cancer with Renal Impairment Based on PK, Safety, and Efficacy Data: An Innovative Approach Integrating Data from a Dedicated Renal Impairment Study and Oncology Clinical Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) by Investigator Assessment |
NA; 14.7 | 0.00000329 sig |
| SECONDARY Overall Survival (OS) |
63.9; 51.4 | 0.004 sig |
| SECONDARY Overall Response Rate (ORR) by Investigator Assessment |
40.7; 27.5 | 0.000155 sig |
| SECONDARY Clinical Benefit Rate (CBR) by Investigator Assessment |
79.6; 72.8 | 0.018 sig |
| SECONDARY Time to Definitive Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) by at Least One Category of the Score |
22.6; NA | — |
| SECONDARY Time to Definitive 10% Deterioration in the Global Health Status/Quality of Life (GHS/QoL) Scale Score of the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC QLQ-C30) |
19.3; NA | — |
| SECONDARY Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30 |
2.9; 4.9; 4.6; 6.8; 4.6; 6.0 | — |
Eligibility Criteria
Key Inclusion Criteria
- Women with advanced (locoregionally recurrent or metastatic) breast cancer that was not amenable to curative therapy.
- The patient was postmenopausal. Postmenopausal status was defined either by:
- Prior bilateral oophorectomy
- Age ≥60
- Age 90 at rest), PR interval > 220 msec, QRS interval >109 msec, or QTcF >450 msec.
- Systolic blood pressure >160 or <90 mmHg.
- The patient was currently receiving any of the following medications and could not be discontinued 7 days prior to the start of treatment:
- Medications known to be strong inducers or inhibitors of CYP3A4.
- Medications known to have a risk of prolonging the QT interval or inducing Torsades de Pointes.
- Medications with a narrow therapeutic window and predominantly metabolized through CYP3A4.
- Herbal preparations/medications.
Data sourced from ClinicalTrials.gov (NCT01958021) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.