Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.

NCT02422615 · MONALEESA-3 Phase 3Completed

Lead sponsor: Novartis Pharmaceuticals (Industry)
Enrollment: 726 (actual)
Start date: 9 Jun 2015
Primary completion: 3 Nov 2017 (actual)
Study completion: 11 Jan 2023
Last update posted: 30 Nov 2023

Design

Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel
Masking: Quadruple
Arms: 2

Interventions

Ribociclib Drug
Fulvestrant Drug
Placebo Drug

Conditions and primary outcome

Advanced Breast Cancer

Primary outcome

Progression Free Survival (PFS) Per Investigator Assessment (From randomization to first documented progression or death, assessed up to approximately 26 months)

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT02422615 (opens in a new tab)· Licence: public-domain

First posted 19 Sep 2018 · Last update posted 30 Nov 2023 · Imported 26 Oct 2026 from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

Progression Free Survival (PFS) Per Investigator Assessment
Time frame
From randomization to first documented progression or death, assessed up to approximately 26 months
Measure
Median
Unit
Months
- Ribociclib + Fulvestrant vs Placebo + FulvestrantSuperiority
  Estimate
  0.593Cox Proportional Hazard
  95% CI, two-sided
  0.480 to 0.732
  p-value
  0.00000041
  Method
  Log Rank

Serious adverse events

Time frame: On-treatment AEs: from 1st dose to 30 days post-treatment (or start of crossover treatment), up to 82 months. Post-treatment efficacy/survival follow-up deaths: from 31 days post-treatment to end of study, up to 82 months. Crossover on-treatment AEs: from 1st dose to 30 days post-crossover treatment, up to 3.5 months. Crossover post-treatment efficacy/survival follow-up deaths: from 31 days post-crossover treatment to end of study, up to 1 year

Participants with serious adverse events per group for MONALEESA-3, as posted
Group	Affected	At risk
Ribociclib + Fulvestrant (On-treatment)	179	483
Ribociclib + Fulvestrant (Post-treatment Efficacy/Survival Follow-up)	0	0
Placebo + Fulvestrant (On-treatment)	51	241
Placebo + Fulvestrant (Post-treatment Efficacy/Survival Follow-up)	0	0
Crossover to Ribociclib + Fulvestrant (Crossover On-treatment)	1	3
Crossover to Ribociclib + Fulvestrant (Crossover Post-treatment Efficacy/Survival Follow-up)	0	0

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

11 on PubMed

Quantitative Pharmacology Justifying Ribociclib Dose in Early Breast Cancer.
Clinical pharmacokinetics · 2026 Aug
PubMed 42334791 (opens in a new tab)DOI 10.1007/s40262-026-01643-3 (opens in a new tab)
Efficacy, safety, and patient-reported outcomes across young to older age groups of patients with HR+/HER2- advanced breast cancer treated with ribociclib plus endocrine therapy in the randomized MONALEESA-2, -3, and -7 trials.
European journal of cancer (Oxford, England : 1990) · 2025 Feb 25
PubMed 39826197 (opens in a new tab)DOI 10.1016/j.ejca.2025.115225 (opens in a new tab)
Pooled ctDNA analysis of MONALEESA phase III advanced breast cancer trials.
Annals of oncology : official journal of the European Society for Medical Oncology · 2023 Nov
PubMed 37673211 (opens in a new tab)DOI 10.1016/j.annonc.2023.08.011 (opens in a new tab)
Updated overall survival from the MONALEESA-3 trial in postmenopausal women with HR+/HER2- advanced breast cancer receiving first-line ribociclib plus fulvestrant.
Breast cancer research : BCR · 2023 Aug 31
PubMed 37653397 (opens in a new tab)DOI 10.1186/s13058-023-01701-9 (opens in a new tab)
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.
Clinical pharmacokinetics · 2023 Mar
PubMed 36800111 (opens in a new tab)DOI 10.1007/s40262-022-01206-2 (opens in a new tab)
Safety and impact of dose reductions on efficacy in the randomised MONALEESA-2, -3 and -7 trials in hormone receptor-positive, HER2-negative advanced breast cancer.
British journal of cancer · 2021 Aug
PubMed 34158598 (opens in a new tab)DOI 10.1038/s41416-021-01415-9 (opens in a new tab)
Ribociclib plus fulvestrant for postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in the phase III randomized MONALEESA-3 trial: updated overall survival.
Annals of oncology : official journal of the European Society for Medical Oncology · 2021 Aug
PubMed 34102253 (opens in a new tab)DOI 10.1016/j.annonc.2021.05.353 (opens in a new tab)
Correlative Biomarker Analysis of Intrinsic Subtypes and Efficacy Across the MONALEESA Phase III Studies.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021 May 1
PubMed 33769862 (opens in a new tab)DOI 10.1200/JCO.20.02977 (opens in a new tab)
Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer.
The New England journal of medicine · 2020 Feb 6
PubMed 31826360 (opens in a new tab)DOI 10.1056/NEJMoa1911149 (opens in a new tab)
MONALEESA clinical program: a review of ribociclib use in different clinical settings.
Future oncology (London, England) · 2019 Aug
PubMed 31305131 (opens in a new tab)DOI 10.2217/fon-2019-0130 (opens in a new tab)
Phase III Randomized Study of Ribociclib and Fulvestrant in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: MONALEESA-3.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2018 Aug 20
PubMed 29860922 (opens in a new tab)DOI 10.1200/JCO.2018.78.9909 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

CT-VCA trial quality

About CT-VCA

Loading CT-VCA scores…

Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Ribociclib

Source

NCT02422615 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read 25 Oct 2026

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Nothing on this page is medical or investment advice.