Trial reportBritish journal of cancer2021
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.
Trial report in British journal of cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 59 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized Double-blind, Placebo-controlled Study of LEE011 in Combination With Letrozole for the Treatment of Postmenopausal Women With Hormone Receptor Positive, HER2 Negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease
A Phase III Randomized, Double-blind, Placebo-controlled Study of LEE011 or Placebo in Combination With Tamoxifen and Goserelin or a Non-steroidal Aromatase Inhibitor (NSAI) and Goserelin for the Treatment of Premenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer
A Randomized Double-blind, Placebo-controlled Study of Ribociclib in Combination With Fulvestrant for the Treatment of Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer Who Have Received no or Only One Line of Prior Endocrine Treatment
Who cites it
59 citing papers in PubMed, 2 syntheses or guidelines pooled it, 86 citations in OpenAlex.
- Guidance for Canadian Breast Cancer Practice: National Consensus Recommendations for the Systemic Treatment of Patients with HR+/HER2- Metastatic Breast Cancer 2025.Current oncology (Toronto, Ont.) · 2026Guideline
- The Impact of Obesity on Treatment Outcomes in Patients with Hormone Receptor-Positive HER2-Negative Metastatic Breast Cancer Receiving CDK 4/6 Inhibitors.Cancer research and treatment · 2026Pooled it
- Trial
- Continuous versus Standard Palbociclib Treatment and Molecular Profiling of Solid Tissues and Liquid Biopsies in the CCTG MA.38 Trial in Advanced Breast Cancer.Cancer research communications · 2025Trial
- Comparing Ribociclib versus Palbociclib as a Second Line Treatment in Combination with Fulvestrant in Metastatic Breast Cancer: A Randomized Clinical Trial.Asian Pacific journal of cancer prevention : APJCP · 2024Trial
- Initial ribociclib plus endocrine therapy for HR+/HER2- advanced breast cancer in pre- and postmenopausal Chinese women: Primary results from a phase 2 randomized study.Cancer medicine · 2024Trial
- Crossing the toxicity threshold: a repeated landmark analysis of early toxicities and treatment modification during first-line CDK4/6 inhibitor therapy.Cancer chemotherapy and pharmacology · 2026Article
- Quantitative Pharmacology Justifying Ribociclib Dose in Early Breast Cancer.Clinical pharmacokinetics · 2026Article
- Switching CDK4/6 inhibitors to overcome toxicity in HR-positive/HER2-negative advanced breast cancer.Tumori · 2026Article
- Real-world progression-free survival and overall survival in patients with HRInternational journal of cancer · 2026Observational
- Prediction of dose reductions and impact of reduced starting doses of CDK4/6i on effectiveness in HR-positive/HER2-negative metastatic breast cancer: Real-world data from the OPAL registry.International journal of cancer · 2026Observational
- Review
- Article
- Real-World Clinical Experience of First-Line Ribociclib Combined with an Aromatase Inhibitor in Metastatic Breast Cancer.Cancers · 2026Article
- Real-World Outcomes of Elacestrant in ER+, HER2-, ESR1-Mutant Metastatic Breast Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Article
- Clinical outcomes and toxicity in metastatic breast cancer patients treated with first or second-line cyclin-dependent kinase (CDK) 4/6 inhibitors and endocrine therapy in Egypt.The Pan African medical journal · 2026Observational
- Development of a Consensus-Based Risk Stratification Algorithm for HR+/HER2- Early Breast Cancer to Guide Adjuvant CDK4/6i Therapy: Outcomes from a Multidisciplinary Workshop in India.Breast cancer (Dove Medical Press) · 2026Article
- Comparative safety signal prioritization of CDK4/6 inhibitors in breast cancer: a FAERS pharmacovigilance, machine learning, and clinical contextualization study.Frontiers in pharmacology · 2026Article
- Integration of pre‑existing cardiovascular comorbidity into CDK4/6 inhibitor selection for breast cancer.Therapeutic advances in drug safety · 2026Article
- CDK4/6 inhibitors for metastatic breast cancer in routine clinical practice in Spain: survey of patterns of use and oncologists' perceptions.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 12 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis pooled analysis of MONALEESA trials evaluated the safety of ribociclib plus endocrine therapy (RIB + ET) with a focus on dose reductions in first-line patients.
methodsIn the dose reduction analysis, data were pooled from MONALEESA-2 (all patients), MONALEESA-3 (patients receiving treatment as first-line ET) and MONALEESA-7 (patients receiving combination therapy with an NSAI as initial ET). Efficacy was analysed by ribociclib relative dose intensity (DI). Safety was analysed in all patients in the trials (except those receiving tamoxifen in MONALEESA-7) and those with/without ≥1 ribociclib dose reduction.
resultsOf 818 women who received first-line RIB + ET, 41.8% required ≥1 dose reduction due to AEs (most commonly, neutropenia). Median RIB relative DI in patients without and with dose reductions was 99.3% and 65.6% in MONALEESA-2, 98.4% and 67.8% in MONALEESA-3 and 98·0% and 66·3% in MONALEESA-7. Median PFS was 24.8, 24.9 and 29.6 months for patients who received ≤71% (30th percentile), 72-96% (60th percentile) and 97-100% (90th percentile) RIB relative DI, respectively. No new safety signals emerged in the pooled safety analysis.
conclusionsThis analysis provides reassuring data showing that the clinical benefit of RIB is preserved when dose modifications are undertaken to manage AEs.
trial registrationMONALEESA-2 (NCT01958021) first posted October 8, 2013; MONALEESA-3 (NCT02422615) first posted April 21, 2015; MONALEESA-7 (NCT02278120) first posted October 29, 2014.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.