Ribociclib Evidence: Trial Results and Peer-Reviewed Publications

Hipa.ai Research · Source: PubMed & ClinicalTrials.gov / AACT · Last updated:

The clinical evidence base for Ribociclib comprises 143 peer-reviewed publications across 15 journals, 5 pivotal-trial primary-outcome rows reported to ClinicalTrials.gov, spanning indications including Breast Neoplasms, Neoplasms, Glioma, and Liposarcoma. Most recent publication: Prospective evaluation of genomics-guided off-label treatment., Nature, 2026.

Top peer-reviewed publications

Curated set of pivotal-trial result papers and recent publications in high-tier journals.

  1. Proposal for standardized definitions for efficacy end points in adjuvant breast cancer trials: the STEEP system.
    Hudis CA, Barlow WE, Costantino JP, et al. · J Clin Oncol · 2007
    PubMed: PMID 17513820 · NCT03078751 (EarLEE-1) · Breast Neoplasms
  2. Conditional progression-free survival in patients with metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer treated with first-line ribociclib and endocrine therapy: real-world data from the RIBANNA study.
    Decker T, Brucker C, Engel A, et al. · ESMO Open · 2025
    PubMed: PMID 40381382 · NCT06311383 (RIBANNA) · Breast Neoplasms
  3. Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer.
    Slamon DJ, Neven P, Chia S, et al. · N Engl J Med · 2020
    PubMed: PMID 31826360 · NCT02422615 (MONALEESA-3) · Breast Neoplasms
  4. Ribociclib plus Endocrine Therapy in Early Breast Cancer.
    Slamon D, Lipatov O, Nowecki Z, et al. · N Engl J Med · 2024
    PubMed: PMID 38507751 · NCT03701334 (NATALEE) · Breast Neoplasms
  5. Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer.
    Hortobagyi GN, Stemmer SM, Burris HA, et al. · N Engl J Med · 2022
    PubMed: PMID 35263519 · NCT01958021 (MONALEESA-2) · Breast Neoplasms
  6. Ribociclib Plus Endocrine Therapy in Hormone Receptor-Positive/ERBB2-Negative Early Breast Cancer: 4-Year Outcomes From the NATALEE Randomized Clinical Trial.
    Fasching PA, Stroyakovskiy D, Yardley DA, et al. · JAMA Oncol · 2025
    PubMed: PMID 40996773 · NCT03701334 (NATALEE) · Breast Neoplasms
  7. 600- vs 400-mg First-Line Ribociclib in Hormone Receptor-Positive/ERBB2-Negative Advanced Breast Cancer: The AMALEE Randomized Clinical Trial.
    Cardoso F, Jacot W, Kuemmel S, et al. · JAMA Oncol · 2025
    PubMed: PMID 40996770 · NCT03822468 (AMALEE) · Breast Neoplasms
  8. First-Line Camizestrant for Emerging ESR1-Mutated Advanced Breast Cancer.
    Bidard FC, Mayer EL, Park YH, et al. · N Engl J Med · 2025
    PubMed: PMID 40454637 · NCT04964934 (SERENA-6) · Breast Neoplasms

Primary-outcome results across pivotal trials

Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.

TrialIndicationPrimary endpointArmValue
NCT01958021
MONALEESA-2
Breast NeoplasmsProgression Free Survival (PFS) by Investigator Assessment
Up to 23 months
Placebo + Letrozole14.7 months
Ribociclib + LetrozoleNA months
NCT02278120
MONALEESA-7
—Progression Free Survival (PFS) by Investigator Assessment
From randomization to first documented progression or death, assessed up to approximately 29 months
Placebo + NSAI/Tamoxifen+ Goserelin13.0 Months
Ribociclib + NSAI/Tamoxifen + Goserelin23.8 Months
NCT02422615
MONALEESA-3
Breast NeoplasmsProgression Free Survival (PFS) Per Investigator Assessment
From randomization to first documented progression or death, assessed up to approximately 26 months
Placebo + Fulvestrant12.8 Months
Ribociclib + Fulvestrant20.5 Months
NCT02941926
COMPLEEMENT-1
Breast NeoplasmsNumber of Participants With Adverse Events (AEs) and Serious AEs (SAEs) During Treatment With Ribociclib + Letrozole in the Core Phase
From start of treatment up to 30 days after last treatment (for participants who did not enter to the Extension phase) or up to last treatment in the Core phase (for participants who entered the Extension phase), assessed up to approximately 33 months.
Ribociclib + Letrozole + Goserelin/Leuprolide392 Participants
Ribociclib + Letrozole + Goserelin/Leuprolide237 Participants
Ribociclib + Letrozole + Goserelin/Leuprolide2434 Participants
Ribociclib + Letrozole + Goserelin/Leuprolide2095 Participants
Ribociclib + Letrozole + Goserelin/Leuprolide2235 Participants
Ribociclib + Letrozole + Goserelin/Leuprolide1964 Participants
Ribociclib + Letrozole + Goserelin/Leuprolide2624 Participants
Ribociclib + Letrozole + Goserelin/Leuprolide844 Participants
Ribociclib + Letrozole + Goserelin/Leuprolide1613 Participants
Ribociclib + Letrozole + Goserelin/Leuprolide3203 Participants
Ribociclib + Letrozole + Goserelin/Leuprolide2461 Participants
Ribociclib + Letrozole + Goserelin/Leuprolide3091 Participants
Ribociclib + Letrozole + Goserelin/Leuprolide2192 Participants
Ribociclib + Letrozole + Goserelin/Leuprolide702 Participants
Ribociclib + Letrozole + Goserelin/Leuprolide590 Participants
Ribociclib + Letrozole + Goserelin/Leuprolide203 Participants
Ribociclib + Letrozole + Goserelin/Leuprolide178 Participants
Ribociclib + Letrozole + Goserelin/Leuprolide62 Participants
Ribociclib + Letrozole + Goserelin/Leuprolide14 Participants
Ribociclib + Letrozole + Goserelin/Leuprolide528 Participants
Ribociclib + Letrozole + Goserelin/Leuprolide310 Participants
Ribociclib + Letrozole + Goserelin/Leuprolide418 Participants
NCT03096847Breast NeoplasmsClinical Benefit Rate (CBR) in Women and Men With Hormone Receptor Positiv, HER-2 Negative Breast Cancer Treated With Ribocilib and Letrozole
At 24 weeks after last patient enrolled in trial
Ribociclib + Letrozole Cohort A63.2 Percentage of Participants
Ribociclib + Letrozole Cohort A71.7 Percentage of Participants
Ribociclib + Letrozole Cohort B157.7 Percentage of Participants
Ribociclib + Letrozole Cohort B169.2 Percentage of Participants
Ribociclib + Letrozole Cohort B264.3 Percentage of Participants
Ribociclib + Letrozole Cohort B256.5 Percentage of Participants
Total60.8 Percentage of Participants
Total69.2 Percentage of Participants

Publications by year

1985–2026: 143 publications.

1985
1
1988
1
1996
1
1998
1
2001
1
2002
3
2005
1
2006
1
2007
2
2008
3
2010
4
2011
1
2012
2
2013
4
2014
1
2015
8
2016
3
2017
6
2018
10
2019
17
2020
11
2021
10
2022
14
2023
14
2024
7
2025
10
2026
6

Publications by indication

Breast Neoplasms (91)

  • Real-world progression-free survival 2 (PFS2) and tumor response of CDK4/6 inhibitors plus an aromatase inhibitor in patients with HR+/HER2- metastatic breast cancer in US routine clinical practice.
    Breast · 2026 · PMID 41950642 · NCT06495164
  • Real-world effectiveness of palbociclib in combination with an aromatase inhibitor in HR+/HER2- bone-only metastatic breast cancer.
    Breast · 2026 · PMID 41830752 · NCT06495164
  • Real-world treatment durations, subsequent treatments, and switching of CDK4/6 inhibitors among patients with HR+/HER2- metastatic breast cancer.
    Oncologist · 2026 · PMID 42095602 · NCT06495164
  • Conditional progression-free survival in patients with metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer treated with first-line ribociclib and endocrine therapy: real-world data from the RIBANNA study.
    ESMO Open · 2025 · PMID 40381382 · NCT06311383
  • Randomised trial of trastuzumab deruxtecan and biology-driven selection of neoadjuvant treatment for HER2-positive breast cancer: a study protocol of ARIADNE.
    BMJ Open · 2025 · PMID 40866060 · NCT05900206

Neoplasms (26)

  • Prospective evaluation of genomics-guided off-label treatment.
    Nature · 2026 · PMID 41986720 · NCT02925234
  • Phase I/II Study of the CDK2/9 Inhibitor Fadraciclib in Combination with Chemotherapy in Children with Advanced Malignancies: Arm K of the AcSé-ESMART Trial.
    Target Oncol · 2026 · PMID 41838385 · NCT02813135
  • Efficacy of Pembrolizumab and Biomarker Analysis in Patients with WGS-Based Intermediate to High Tumor Mutational Load: Results from the Drug Rediscovery Protocol.
    Clin Cancer Res · 2024 · PMID 38630551 · NCT02925234
  • Limited clinical activity of palbociclib and ribociclib monotherapy in advanced cancers with cyclin D-CDK4/6 pathway alterations in the Dutch DRUP and Australian MoST trials.
    Int J Cancer · 2023 · PMID 37424386 · NCT02925234
  • Efficacy, safety and biomarker analysis of durvalumab in patients with mismatch-repair deficient or microsatellite instability-high solid tumours.
    BMC Cancer · 2023 · PMID 36870947 · NCT02925234

Glioma (5)

  • Single-nucleus transcriptomics, pharmacokinetics, and pharmacodynamics of CDK4/6 and mTOR inhibition in a Phase 0/1 trial of recurrent high-grade glioma.
    Neuro Oncol · 2026 · PMID 41206763 · NCT03834740
  • Single nucleus transcriptomics, pharmacokinetics, and pharmacodynamics of combined CDK4/6 and mTOR inhibition in a phase 0/1 trial of recurrent high-grade glioma.
    medRxiv · 2025 · PMID 38883740 · NCT03834740
  • A phase I/II study of ribociclib following radiation therapy in children with newly diagnosed diffuse intrinsic pontine glioma (DIPG).
    J Neurooncol · 2021 · PMID 33034839 · NCT02607124
  • Tumor pharmacokinetics and pharmacodynamics of the CDK4/6 inhibitor ribociclib in patients with recurrent glioblastoma.
    J Neurooncol · 2020 · PMID 31399936 · NCT02345824
  • Tumor Response Assessment in Diffuse Intrinsic Pontine Glioma: Comparison of Semiautomated Volumetric, Semiautomated Linear, and Manual Linear Tumor Measurement Strategies.
    AJNR Am J Neuroradiol · 2020 · PMID 32354716 · NCT02607124

Liposarcoma (5)

  • Phase II trial of the CDK4 inhibitor PD0332991 in patients with advanced CDK4-amplified well-differentiated or dedifferentiated liposarcoma.
    J Clin Oncol · 2013 · PMID 23569312 · NCT02571829
  • Subtype-specific genomic alterations define new targets for soft-tissue sarcoma therapy.
    Nat Genet · 2010 · PMID 20601955 · NCT02571829
  • Cyclin-dependent kinase pathways as targets for cancer treatment.
    J Clin Oncol · 2006 · PMID 16603719 · NCT02571829
  • Progression-free rate as the principal end-point for phase II trials in soft-tissue sarcomas.
    Eur J Cancer · 2002 · PMID 11872347 · NCT02571829
  • Cyclin D-dependent kinases, INK4 inhibitors and cancer.
    Biochim Biophys Acta · 2002 · PMID 11960696 · NCT02571829

Carcinoma, Non-Small-Cell Lung (3)

  • A phase Ib study of the combination of naporafenib with rineterkib or trametinib in patients with advanced and metastatic KRAS- or BRAF-mutant non-small cell lung cancer.
    Lung Cancer · 2024 · PMID 39383771 · NCT02974725
  • Initial Evidence for the Efficacy of Naporafenib in Combination With Trametinib in NRAS-Mutant Melanoma: Results From the Expansion Arm of a Phase Ib, Open-Label Study.
    J Clin Oncol · 2023 · PMID 36947734 · NCT02974725
  • Tumor Cell-Autonomous SHP2 Contributes to Immune Suppression in Metastatic Breast Cancer.
    Cancer Res Commun · 2023 · PMID 36969745 · NCT04000529

Neoplasm Metastasis (2)

  • A Phase I Study of sequences of the CDK4/6 Inhibitor, Ribociclib Combined with Gemcitabine in Patients with Advanced Solid Tumors.
    Res Sq · 2025 · PMID 38746220 · NCT03237390
  • A phase I study of the CDK4/6 inhibitor ribociclib combined with gemcitabine in patients with advanced solid tumors.
    BJC Rep · 2025 · PMID 39809926 · NCT03237390

Publications by journal

Trial-results highlights

Clinical trials have investigated Ribociclib in various settings. In the MONALEESA-3 study (NCT02422615) for breast neoplasms, the median Progression Free Survival (PFS) per investigator assessment was 20.5 Months for participants receiving Ribociclib + Fulvestrant, compared to 12.8 Months for those receiving Placebo + Fulvestrant. Another study, NCT02278120, reported a median PFS of 23.8 Months for participants on Ribociclib + NSAI/Tamoxifen + Goserelin, versus 13.0 Months for those on Placebo + NSAI/Tamoxifen + Goserelin. For breast neoplasms in the MONALEESA-2 study (NCT01958021), the median PFS by investigator assessment was 14.7 months for participants treated with Placebo + Letrozole.

Safety and clinical benefit rates have also been assessed. In the COMPLEEMENT-1 study (NCT02941926) for breast neoplasms, the number of participants with adverse events (AEs) and serious AEs (SAEs) during treatment with Ribociclib + Letrozole + Goserelin/Leuprolide included:

  • 392 Participants
  • 237 Participants
  • 2434 Participants
  • 2095 Participants
  • 2235 Participants
  • 1964 Participants

A separate study (NCT03096847) for breast neoplasms evaluated the Clinical Benefit Rate (CBR) in women and men treated with Ribociclib and Letrozole. The CBR was observed in:

  • 63.2 Percentage of Participants and 71.7 Percentage of Participants in Ribociclib + Letrozole Cohort A
  • 57.7 Percentage of Participants and 69.2 Percentage of Participants in Ribociclib + Letrozole Cohort B1
  • 64.3 Percentage of Participants and 56.5 Percentage of Participants in Ribociclib + Letrozole Cohort B2

All values presented are sourced from primary registry reporting. Individual papers should be consulted for clinical decisions.

All Ribociclib publications (143)

2026 (6 papers)

  1. Prospective evaluation of genomics-guided off-label treatment.
    Verkerk K, Spiekman AC, Haj Mohammad SF, et al. · Nature · 2026 · Derived
    PubMed: PMID 41986720 · NCT02925234 (DRUP) · Neoplasms
  2. Real-world progression-free survival 2 (PFS2) and tumor response of CDK4/6 inhibitors plus an aromatase inhibitor in patients with HR+/HER2- metastatic breast cancer in US routine clinical practice.
    Rugo HS, Brufsky A, Layman RM, et al. · Breast · 2026 · Derived
    PubMed: PMID 41950642 · NCT06495164 · Breast Neoplasms
  3. Phase I/II Study of the CDK2/9 Inhibitor Fadraciclib in Combination with Chemotherapy in Children with Advanced Malignancies: Arm K of the AcSé-ESMART Trial.
    Rubio-San-Simón A, Marshall LV, Karamouza E, et al. · Target Oncol · 2026 · Derived
    PubMed: PMID 41838385 · NCT02813135 (ESMART) · Neoplasms
  4. Single-nucleus transcriptomics, pharmacokinetics, and pharmacodynamics of CDK4/6 and mTOR inhibition in a Phase 0/1 trial of recurrent high-grade glioma.
    Johnson KC, Tien AC, Jiang J, et al. · Neuro Oncol · 2026 · Derived
    PubMed: PMID 41206763 · NCT03834740 · Glioma
  5. Real-world effectiveness of palbociclib in combination with an aromatase inhibitor in HR+/HER2- bone-only metastatic breast cancer.
    Brufsky A, Layman RM, Liu X, et al. · Breast · 2026 · Derived
    PubMed: PMID 41830752 · NCT06495164 · Breast Neoplasms
  6. Real-world treatment durations, subsequent treatments, and switching of CDK4/6 inhibitors among patients with HR+/HER2- metastatic breast cancer.
    Brufsky A, Layman RM, Liu X, et al. · Oncologist · 2026 · Derived
    PubMed: PMID 42095602 · NCT06495164 · Breast Neoplasms

2025 (10 papers)

  1. Conditional progression-free survival in patients with metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer treated with first-line ribociclib and endocrine therapy: real-world data from the RIBANNA study.
    Decker T, Brucker C, Engel A, et al. · ESMO Open · 2025 · Trial result
    PubMed: PMID 40381382 · NCT06311383 (RIBANNA) · Breast Neoplasms
  2. A Phase I Study of sequences of the CDK4/6 Inhibitor, Ribociclib Combined with Gemcitabine in Patients with Advanced Solid Tumors.
    Seetharam M, Norman A, Allred J, et al. · Res Sq · 2025 · Derived
    PubMed: PMID 38746220 · NCT03237390 · Neoplasm Metastasis
  3. A phase I study of the CDK4/6 inhibitor ribociclib combined with gemcitabine in patients with advanced solid tumors.
    Norman A, Seetharam M, Allred J, et al. · BJC Rep · 2025 · Derived
    PubMed: PMID 39809926 · NCT03237390 · Neoplasm Metastasis
  4. Randomised trial of trastuzumab deruxtecan and biology-driven selection of neoadjuvant treatment for HER2-positive breast cancer: a study protocol of ARIADNE.
    Matikas A, Naume B, Wildiers H, et al. · BMJ Open · 2025 · Derived
    PubMed: PMID 40866060 · NCT05900206 (ARIADNE) · Breast Neoplasms
  5. Real-world effectiveness of palbociclib plus an aromatase inhibitor in HR+/HER2- MBC patients living in disadvantaged neighborhoods.
    Lynce F, Liu X, Li B, et al. · NPJ Breast Cancer · 2025 · Derived
    PubMed: PMID 40691446 · NCT06495164 · Breast Neoplasms
  6. Single nucleus transcriptomics, pharmacokinetics, and pharmacodynamics of combined CDK4/6 and mTOR inhibition in a phase 0/1 trial of recurrent high-grade glioma.
    Johnson KC, Tien AC, Jiang J, et al. · medRxiv · 2025 · Derived
    PubMed: PMID 38883740 · NCT03834740 · Glioma
  7. 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.
    Hart LL, Im SA, Tolaney SM, et al. · Eur J Cancer · 2025 · Derived
    PubMed: PMID 39826197 · NCT02278120 (MONALEESA-7)
  8. Ribociclib Plus Endocrine Therapy in Hormone Receptor-Positive/ERBB2-Negative Early Breast Cancer: 4-Year Outcomes From the NATALEE Randomized Clinical Trial.
    Fasching PA, Stroyakovskiy D, Yardley DA, et al. · JAMA Oncol · 2025 · Derived
    PubMed: PMID 40996773 · NCT03701334 (NATALEE) · Breast Neoplasms
  9. 600- vs 400-mg First-Line Ribociclib in Hormone Receptor-Positive/ERBB2-Negative Advanced Breast Cancer: The AMALEE Randomized Clinical Trial.
    Cardoso F, Jacot W, Kuemmel S, et al. · JAMA Oncol · 2025 · Derived
    PubMed: PMID 40996770 · NCT03822468 (AMALEE) · Breast Neoplasms
  10. First-Line Camizestrant for Emerging ESR1-Mutated Advanced Breast Cancer.
    Bidard FC, Mayer EL, Park YH, et al. · N Engl J Med · 2025 · Derived
    PubMed: PMID 40454637 · NCT04964934 (SERENA-6) · Breast Neoplasms

2024 (7 papers)

  1. Radiopharmaceuticals for Cancer Diagnosis and Therapy: New Targets, New Therapies-Alpha-Emitters, Novel Targets.
    Taunk NK, Escorcia FE, Lewis JS, et al. · Cancer J · 2024 · Derived
    PubMed: PMID 38753757 · NCT05870579 · Breast Neoplasms
  2. Ribociclib plus Endocrine Therapy in Early Breast Cancer.
    Slamon D, Lipatov O, Nowecki Z, et al. · N Engl J Med · 2024 · Derived
    PubMed: PMID 38507751 · NCT03701334 (NATALEE) · Breast Neoplasms
  3. A phase Ib study of the combination of naporafenib with rineterkib or trametinib in patients with advanced and metastatic KRAS- or BRAF-mutant non-small cell lung cancer.
    Planchard D, Wolf J, Solomon B, et al. · Lung Cancer · 2024 · Derived
    PubMed: PMID 39383771 · NCT02974725 · Carcinoma, Non-Small-Cell Lung
  4. Final Results of RIGHT Choice: Ribociclib Plus Endocrine Therapy Versus Combination Chemotherapy in Premenopausal Women With Clinically Aggressive Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer.
    Lu YS, Mahidin EIBM, Azim H, et al. · J Clin Oncol · 2024 · Derived
    PubMed: PMID 38771995 · NCT03839823 (RIGHT Choice) · Breast Neoplasms
  5. Matching-adjusted indirect comparison of PFS and OS comparing ribociclib plus letrozole versus palbociclib plus letrozole as first-line treatment of HR+/HER2- advanced breast cancer.
    Jhaveri K, O'Shaughnessy J, Fasching PA, et al. · Ther Adv Med Oncol · 2024 · Derived
    PubMed: PMID 38107828 · NCT01958021 (MONALEESA-2) · Breast Neoplasms
  6. Efficacy of Pembrolizumab and Biomarker Analysis in Patients with WGS-Based Intermediate to High Tumor Mutational Load: Results from the Drug Rediscovery Protocol.
    Geurts BS, Zeverijn LJ, Leek LVM, et al. · Clin Cancer Res · 2024 · Derived
    PubMed: PMID 38630551 · NCT02925234 (DRUP) · Neoplasms
  7. The NEOLETRIB trial: neoadjuvant treatment with Letrozole and Ribociclib in ER-positive, HER2-negative breast cancer.
    Fjermeros K, Ghannoum S, Geisler SB, et al. · Future Oncol · 2024 · Derived
    PubMed: PMID 39073142 · NCT05163106 (NEOLETRIB) · Breast Neoplasms

2023 (14 papers)

  1. Limited clinical activity of palbociclib and ribociclib monotherapy in advanced cancers with cyclin D-CDK4/6 pathway alterations in the Dutch DRUP and Australian MoST trials.
    Zeverijn LJ, Looze EJ, Thavaneswaran S, et al. · Int J Cancer · 2023 · Derived
    PubMed: PMID 37424386 · NCT02925234 (DRUP) · Neoplasms
  2. Design of SERENA-6, a phase III switching trial of camizestrant in ESR1-mutant breast cancer during first-line treatment.
    Turner N, Huang-Bartlett C, Kalinsky K, et al. · Future Oncol · 2023 · Derived
    PubMed: PMID 37070653 · NCT04964934 (SERENA-6) · Breast Neoplasms
  3. Rationale and trial design of NATALEE: a Phase III trial of adjuvant ribociclib + endocrine therapy versus endocrine therapy alone in patients with HR+/HER2- early breast cancer.
    Slamon DJ, Fasching PA, Hurvitz S, et al. · Ther Adv Med Oncol · 2023 · Derived
    PubMed: PMID 37275963 · NCT03701334 (NATALEE) · Breast Neoplasms
  4. Quality of life with ribociclib versus abemaciclib as first-line treatment of HR+/HER2- advanced breast cancer: a matching-adjusted indirect comparison.
    Rugo HS, Harmer V, O'Shaughnessy J, et al. · Ther Adv Med Oncol · 2023 · Derived
    PubMed: PMID 36861085 · NCT01958021 (MONALEESA-2) · Breast Neoplasms
  5. Updated overall survival from the MONALEESA-3 trial in postmenopausal women with HR+/HER2- advanced breast cancer receiving first-line ribociclib plus fulvestrant.
    Neven P, Fasching PA, Chia S, et al. · Breast Cancer Res · 2023 · Derived
    PubMed: PMID 37653397 · NCT02422615 (MONALEESA-3) · Breast Neoplasms
  6. Corrected QT Interval (QTc) Diagnostic App for the Oncological Routine: Development Study.
    Klier K, Patel YJ, Schinköthe T, et al. · JMIR Cardio · 2023 · Derived
    PubMed: PMID 37695655 · NCT04055493 (ADAPTcycle) · Breast Neoplasms
  7. Randomized Phase II Trial of Endocrine Therapy With or Without Ribociclib After Progression on Cyclin-Dependent Kinase 4/6 Inhibition in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer: MAINTAIN Trial.
    Kalinsky K, Accordino MK, Chiuzan C, et al. · J Clin Oncol · 2023 · Derived
    PubMed: PMID 37207300 · NCT05207709 (HARMONIA) · Breast Neoplasms
  8. 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.
    Ji Y, Yartsev V, Quinlan M, et al. · Clin Pharmacokinet · 2023 · Derived
    PubMed: PMID 36800111 · NCT01958021 (MONALEESA-2) · Breast Neoplasms
  9. Efficacy, safety and biomarker analysis of durvalumab in patients with mismatch-repair deficient or microsatellite instability-high solid tumours.
    Geurts BS, Battaglia TW, van Berge Henegouwen JM, et al. · BMC Cancer · 2023 · Derived
    PubMed: PMID 36870947 · NCT02925234 (DRUP) · Neoplasms
  10. Anti-hormonal maintenance treatment with the CDK4/6 inhibitor ribociclib after 1st line chemotherapy in hormone receptor positive / HER2 negative metastatic breast cancer: A phase II trial (AMICA).
    Decker T, Lüdtke-Heckenkamp K, Melnichuk L, et al. · Breast · 2023 · Derived
    PubMed: PMID 37690320 · NCT03555877 (AMICA)
  11. Initial Evidence for the Efficacy of Naporafenib in Combination With Trametinib in NRAS-Mutant Melanoma: Results From the Expansion Arm of a Phase Ib, Open-Label Study.
    de Braud F, Dooms C, Heist RS, et al. · J Clin Oncol · 2023 · Derived
    PubMed: PMID 36947734 · NCT02974725 · Carcinoma, Non-Small-Cell Lung
  12. Tumor Cell-Autonomous SHP2 Contributes to Immune Suppression in Metastatic Breast Cancer.
    Chen H, Cresswell GM, Libring S, et al. · Cancer Res Commun · 2023 · Derived
    PubMed: PMID 36969745 · NCT04000529 · Carcinoma, Non-Small-Cell Lung
  13. Pooled ctDNA analysis of MONALEESA phase III advanced breast cancer trials.
    André F, Su F, Solovieff N, et al. · Ann Oncol · 2023 · Derived
    PubMed: PMID 37673211 · NCT02422615 (MONALEESA-3) · Breast Neoplasms
  14. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer.
    Hortobagyi GN, Stemmer SM, Burris HA, et al. · Ann Oncol · 2023 · Background
    PubMed: PMID 31407010 · NCT05163106 (NEOLETRIB) · Breast Neoplasms

2022 (14 papers)

  1. Pre-operative ribociclib plus letrozole versus chemotherapy: Health-related quality of life outcomes from the SOLTI CORALLEEN trial.
    Villacampa G, Falato C, Paré L, et al. · Eur J Cancer · 2022 · Derived
    PubMed: PMID 36067616 · NCT03248427 (CORALLEEN) · Breast Neoplasms
  2. Efficacy and toxicity of vemurafenib and cobimetinib in relation to plasma concentrations, after administration via feeding tube in patients with BRAF-mutated thyroid cancer: a case series and review of literature.
    van Berge Henegouwen JM, van der Wijngaart H, Zeverijn LJ, et al. · Cancer Chemother Pharmacol · 2022 · Derived
    PubMed: PMID 35598186 · NCT02925234 (DRUP) · Neoplasms
  3. Safety and efficacy of ribociclib plus letrozole in patients with HR+, HER2- advanced breast cancer: Results from the Spanish sub-population of the phase 3b CompLEEment-1 trial.
    Salvador Bofill J, Moreno Anton F, Rodriguez Sanchez CA, et al. · Breast · 2022 · Derived
    PubMed: PMID 36206609 · NCT02941926 (COMPLEEMENT-1) · Breast Neoplasms
  4. Treatment with ribociclib shows favourable immunomodulatory effects in patients with hormone receptor-positive breast cancer-findings from the RIBECCA trial.
    Peuker CA, Yaghobramzi S, Grunert C, et al. · Eur J Cancer · 2022 · Derived
    PubMed: PMID 34953442 · NCT03096847 · Breast Neoplasms
  5. Comprehensive Molecular Characterization Reveals Genomic and Transcriptomic Subtypes of Metastatic Urothelial Carcinoma.
    Nakauma-González JA, Rijnders M, van Riet J, et al. · Eur Urol · 2022 · Derived
    PubMed: PMID 35086719 · NCT02925234 (DRUP) · Neoplasms
  6. War against NRAS-Mutant Melanoma Using Targeted Therapies Remains Challenging.
    Moschos SJ · Clin Cancer Res · 2022 · Derived
    PubMed: PMID 35587446 · NCT04417621 · Melanoma
  7. Updated Overall Survival of Ribociclib plus Endocrine Therapy versus Endocrine Therapy Alone in Pre- and Perimenopausal Patients with HR+/HER2- Advanced Breast Cancer in MONALEESA-7: A Phase III Randomized Clinical Trial.
    Lu YS, Im SA, Colleoni M, et al. · Clin Cancer Res · 2022 · Derived
    PubMed: PMID 34965945 · NCT02278120 (MONALEESA-7)
  8. Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer.
    Hortobagyi GN, Stemmer SM, Burris HA, et al. · N Engl J Med · 2022 · Derived
    PubMed: PMID 35263519 · NCT01958021 (MONALEESA-2) · Breast Neoplasms
  9. Safety and Efficacy of Ribociclib in Combination with Letrozole in Patients with HR+, HER2- Advanced Breast Cancer: Results from the Italian Subpopulation of Phase 3b CompLEEment-1 Study.
    De Laurentiis M, Caputo R, Mazza M, et al. · Target Oncol · 2022 · Derived
    PubMed: PMID 36152144 · NCT02941926 (COMPLEEMENT-1) · Breast Neoplasms
  10. Phase I trial of ribociclib with platinum chemotherapy in ovarian cancer.
    Coffman LG, Orellana TJ, Liu T, et al. · JCI Insight · 2022 · Derived
    PubMed: PMID 35972817 · NCT03056833 · Ovarian Neoplasms
  11. Ribociclib Plus Letrozole in Italian Male Patients with Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Case Studies of Phase 3b CompLEEment-1 Trial.
    Caputo R, Fabi A, Romagnoli E, et al. · Breast Cancer (Dove Med Press) · 2022 · Derived
    PubMed: PMID 36267663 · NCT02941926 (COMPLEEMENT-1) · Breast Neoplasms
  12. Ribociclib plus letrozole in male patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: subgroup analysis of the phase IIIb CompLEEment-1 trial.
    Campone M, De Laurentiis M, Zamagni C, et al. · Breast Cancer Res Treat · 2022 · Derived
    PubMed: PMID 35212906 · NCT02941926 (COMPLEEMENT-1) · Breast Neoplasms
  13. The European MAPPYACTS Trial: Precision Medicine Program in Pediatric and Adolescent Patients with Recurrent Malignancies.
    Berlanga P, Pierron G, Lacroix L, et al. · Cancer Discov · 2022 · Derived
    PubMed: PMID 35292802 · NCT02813135 (ESMART) · Neoplasms
  14. Genomic Profiling of Premenopausal HR+ and HER2- Metastatic Breast Cancer by Circulating Tumor DNA and Association of Genetic Alterations With Therapeutic Response to Endocrine Therapy and Ribociclib.
    Bardia A, Su F, Solovieff N, et al. · JCO Precis Oncol · 2022 · Derived
    PubMed: PMID 34504990 · NCT02278120 (MONALEESA-7)

2021 (10 papers)

  1. 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.
    Slamon DJ, Neven P, Chia S, et al. · Ann Oncol · 2021 · Derived
    PubMed: PMID 34102253 · NCT02422615 (MONALEESA-3) · Breast Neoplasms
  2. Correlative Biomarker Analysis of Intrinsic Subtypes and Efficacy Across the MONALEESA Phase III Studies.
    Prat A, Chaudhury A, Solovieff N, et al. · J Clin Oncol · 2021 · Derived
    PubMed: PMID 33769862 · NCT02278120 (MONALEESA-7)
  3. Phase II and biomarker study of programmed cell death protein 1 inhibitor nivolumab and metronomic cyclophosphamide in paediatric relapsed/refractory solid tumours: Arm G of AcSé-ESMART, a trial of the European Innovative Therapies for Children With Cancer Consortium.
    Pasqualini C, Rubino J, Brard C, et al. · Eur J Cancer · 2021 · Derived
    PubMed: PMID 33892407 · NCT02813135 (ESMART) · Neoplasms
  4. First-in-child phase I/II study of the dual mTORC1/2 inhibitor vistusertib (AZD2014) as monotherapy and in combination with topotecan-temozolomide in children with advanced malignancies: arms E and F of the AcSé-ESMART trial.
    Morscher RJ, Brard C, Berlanga P, et al. · Eur J Cancer · 2021 · Derived
    PubMed: PMID 34543871 · NCT02813135 (ESMART) · Neoplasms
  5. A phase I/II study of ribociclib following radiation therapy in children with newly diagnosed diffuse intrinsic pontine glioma (DIPG).
    DeWire M, Fuller C, Hummel TR, et al. · J Neurooncol · 2021 · Derived
    PubMed: PMID 33034839 · NCT02607124 · Glioma
  6. Full population results from the core phase of CompLEEment-1, a phase 3b study of ribociclib plus letrozole as first-line therapy for advanced breast cancer in an expanded population.
    De Laurentiis M, Borstnar S, Campone M, et al. · Breast Cancer Res Treat · 2021 · Derived
    PubMed: PMID 34414532 · NCT02941926 (COMPLEEMENT-1) · Breast Neoplasms
  7. Phase II trial of ribociclib and letrozole in patients with relapsed oestrogen receptor-positive ovarian or endometrial cancers.
    Colon-Otero G, Zanfagnin V, Hou X, et al. · ESMO Open · 2021 · Derived
    PubMed: PMID 33109627 · NCT02657928 · Ovarian Neoplasms
  8. 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.
    Burris HA, Chan A, Bardia A, et al. · Br J Cancer · 2021 · Derived
    PubMed: PMID 34158598 · NCT02422615 (MONALEESA-3) · Breast Neoplasms
  9. Phase I or II Study of Ribociclib in Combination With Topotecan-Temozolomide or Everolimus in Children With Advanced Malignancies: Arms A and B of the AcSé-ESMART Trial.
    Bautista F, Paoletti X, Rubino J, et al. · J Clin Oncol · 2021 · Derived
    PubMed: PMID 34347542 · NCT02813135 (ESMART) · Neoplasms
  10. Serum cytokine levels in breast cancer patients during neoadjuvant treatment with bevacizumab.
    Jabeen S, Zucknick M, Nome M, et al. · Oncoimmunology · 2021 · Background
    PubMed: PMID 30377556 · NCT05163106 (NEOLETRIB) · Breast Neoplasms

2020 (11 papers)

  1. MONALEESA clinical program: a review of ribociclib use in different clinical settings.
    Yardley DA · Future Oncol · 2020 · Derived
    PubMed: PMID 31305131 · NCT01958021 (MONALEESA-2) · Breast Neoplasms
  2. Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer.
    Slamon DJ, Neven P, Chia S, et al. · N Engl J Med · 2020 · Derived
    PubMed: PMID 31826360 · NCT02422615 (MONALEESA-3) · Breast Neoplasms
  3. Sequential or combined designs for Phase I/II clinical trials? A simulation study.
    Rossoni C, Bardet A, Geoerger B, et al. · Clin Trials · 2020 · Derived
    PubMed: PMID 31538815 · NCT02813135 (ESMART) · Neoplasms
  4. Ribociclib plus letrozole versus chemotherapy for postmenopausal women with hormone receptor-positive, HER2-negative, luminal B breast cancer (CORALLEEN): an open-label, multicentre, randomised, phase 2 trial.
    Prat A, Saura C, Pascual T, et al. · Lancet Oncol · 2020 · Derived
    PubMed: PMID 31838010 · NCT03248427 (CORALLEEN) · Breast Neoplasms
  5. Tumor pharmacokinetics and pharmacodynamics of the CDK4/6 inhibitor ribociclib in patients with recurrent glioblastoma.
    Miller TW, Traphagen NA, Li J, et al. · J Neurooncol · 2020 · Derived
    PubMed: PMID 31399936 · NCT02345824 · Glioma
  6. Ribociclib Plus Trastuzumab in Advanced HER2-Positive Breast Cancer: Results of a Phase 1b/2 Trial.
    Goel S, Pernas S, Tan-Wasielewski Z, et al. · Clin Breast Cancer · 2020 · Derived
    PubMed: PMID 31235441 · NCT02657343 · Breast Neoplasms
  7. Tumor Response Assessment in Diffuse Intrinsic Pontine Glioma: Comparison of Semiautomated Volumetric, Semiautomated Linear, and Manual Linear Tumor Measurement Strategies.
    Gilligan LA, DeWire-Schottmiller MD, Fouladi M, et al. · AJNR Am J Neuroradiol · 2020 · Derived
    PubMed: PMID 32354716 · NCT02607124 · Glioma
  8. An independent poor-prognosis subtype of breast cancer defined by a distinct tumor immune microenvironment.
    Tekpli X, Lien T, Røssevold AH, et al. · Nat Commun · 2020 · Background
    PubMed: PMID 31796750 · NCT05163106 (NEOLETRIB) · Breast Neoplasms
  9. Immunomodulation by anticancer cell cycle inhibitors.
    Petroni G, Formenti SC, Chen-Kiang S, et al. · Nat Rev Immunol · 2020 · Background
    PubMed: PMID 32346095 · NCT05163106 (NEOLETRIB) · Breast Neoplasms
  10. CDK4/6 inhibitors in breast cancer: a role in triple-negative disease?
    Goel S, Tolaney SM · Lancet Oncol · 2020 · Background
    PubMed: PMID 31575504 · NCT05163106 (NEOLETRIB) · Breast Neoplasms
  11. Ribociclib with an Aromatase Inhibitor for Previously Untreated, HR-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.
    Büyükkaramikli NC, de Groot S, Riemsma R, et al. · Pharmacoeconomics · 2020 · Background
    PubMed: PMID 30194622 · NCT05163106 (NEOLETRIB) · Breast Neoplasms

2019 (17 papers)

  1. Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial.
    Tripathy D, Im SA, Colleoni M, et al. · Lancet Oncol · 2019 · Derived
    PubMed: PMID 29804902 · NCT02278120 (MONALEESA-7)
  2. Phase III Randomized Study of Ribociclib and Fulvestrant in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: MONALEESA-3.
    Slamon DJ, Neven P, Chia S, et al. · J Clin Oncol · 2019 · Derived
    PubMed: PMID 29860922 · NCT02422615 (MONALEESA-3) · Breast Neoplasms
  3. First-line ribociclib plus letrozole in postmenopausal women with HR+ , HER2- advanced breast cancer: Tumor response and pain reduction in the phase 3 MONALEESA-2 trial.
    Janni W, Alba E, Bachelot T, et al. · Breast Cancer Res Treat · 2019 · Derived
    PubMed: PMID 29404806 · NCT01958021 (MONALEESA-2) · Breast Neoplasms
  4. Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer.
    Im SA, Lu YS, Bardia A, et al. · N Engl J Med · 2019 · Derived
    PubMed: PMID 31166679 · NCT02278120 (MONALEESA-7)
  5. Ribociclib for the first-line treatment of advanced hormone receptor-positive breast cancer: a review of subgroup analyses from the MONALEESA-2 trial.
    Hortobagyi GN · Breast Cancer Res · 2019 · Derived
    PubMed: PMID 30340505 · NCT01958021 (MONALEESA-2) · Breast Neoplasms
  6. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer.
    Hortobagyi GN, Stemmer SM, Burris HA, et al. · Ann Oncol · 2019 · Derived
    PubMed: PMID 29718092 · NCT01958021 (MONALEESA-2) · Breast Neoplasms
  7. Palbociclib plus endocrine therapy in older women with HR+/HER2- advanced breast cancer: a pooled analysis of randomised PALOMA clinical studies.
    Rugo HS, Turner NC, Finn RS, et al. · Eur J Cancer · 2019 · Background
    PubMed: PMID 30053671 · NCT03944434 (FACILE) · Breast Neoplasms
  8. The gut microbiota influences anticancer immunosurveillance and general health.
    Routy B, Gopalakrishnan V, Daillère R, et al. · Nat Rev Clin Oncol · 2019 · Background
    PubMed: PMID 29636538 · NCT05163106 (NEOLETRIB) · Breast Neoplasms
  9. Ribociclib and Endocrine Therapy in Breast Cancer.
    Rocca A, Melegari E, Palleschi M, et al. · N Engl J Med · 2019 · Background
    PubMed: PMID 31618549 · NCT05163106 (NEOLETRIB) · Breast Neoplasms
  10. Palbociclib and Fulvestrant in Breast Cancer.
    McCaw ZR, Vassy JL, Wei LJ, et al. · N Engl J Med · 2019 · Background
    PubMed: PMID 30789681 · NCT05163106 (NEOLETRIB) · Breast Neoplasms
  11. Cancer immunotherapy in 2017: The breakthrough of the microbiota.
    Kroemer G, Zitvogel L · Nat Rev Immunol · 2019 · Background
    PubMed: PMID 29379189 · NCT05163106 (NEOLETRIB) · Breast Neoplasms
  12. Randomized Phase II Study Evaluating Palbociclib in Addition to Letrozole as Neoadjuvant Therapy in Estrogen Receptor-Positive Early Breast Cancer: PALLET Trial.
    Johnston S, Puhalla S, Wheatley D, et al. · J Clin Oncol · 2019 · Background
    PubMed: PMID 30523750 · NCT05163106 (NEOLETRIB) · Breast Neoplasms
  13. Neoadjuvant treatment with trastuzumab and pertuzumab plus palbociclib and fulvestrant in HER2-positive, ER-positive breast cancer (NA-PHER2): an exploratory, open-label, phase 2 study.
    Gianni L, Bisagni G, Colleoni M, et al. · Lancet Oncol · 2019 · Background
    PubMed: PMID 29326029 · NCT05163106 (NEOLETRIB) · Breast Neoplasms
  14. The intimate relationship between gut microbiota and cancer immunotherapy.
    Elkrief A, Derosa L, Zitvogel L, et al. · Gut Microbes · 2019 · Background
    PubMed: PMID 30339501 · NCT05163106 (NEOLETRIB) · Breast Neoplasms
  15. CDK4/6 Inhibition Augments Antitumor Immunity by Enhancing T-cell Activation.
    Deng J, Wang ES, Jenkins RW, et al. · Cancer Discov · 2019 · Background
    PubMed: PMID 29101163 · NCT05163106 (NEOLETRIB) · Breast Neoplasms
  16. Letrozole and palbociclib versus chemotherapy as neoadjuvant therapy of high-risk luminal breast cancer.
    Cottu P, D'Hondt V, Dureau S, et al. · Ann Oncol · 2019 · Background
    PubMed: PMID 30307466 · NCT05163106 (NEOLETRIB) · Breast Neoplasms
  17. Neoadjuvant palbociclib on ER+ breast cancer (N007): clinical response and EndoPredict's value.
    Chow LWC, Morita S, Chow CYC, et al. · Endocr Relat Cancer · 2019 · Background
    PubMed: PMID 29158285 · NCT05163106 (NEOLETRIB) · Breast Neoplasms

2018 (10 papers)

  1. Cyclin D-CDK4 kinase destabilizes PD-L1 via cullin 3-SPOP to control cancer immune surveillance.
    Zhang J, Bu X, Wang H, et al. · Nature · 2018 · Background
    PubMed: PMID 29160310 · NCT05163106 (NEOLETRIB) · Breast Neoplasms
  2. Dual ALK and CDK4/6 Inhibition Demonstrates Synergy against Neuroblastoma.
    Wood AC, Krytska K, Ryles HT, et al. · Clin Cancer Res · 2018 · Background
    PubMed: PMID 27986745 · NCT02780128 (NEPENTHE) · Neoplasms
  3. Overall Survival with Palbociclib and Fulvestrant in Advanced Breast Cancer.
    Turner NC, Slamon DJ, Ro J, et al. · N Engl J Med · 2018 · Background
    PubMed: PMID 30345905 · NCT05163106 (NEOLETRIB) · Breast Neoplasms
  4. Ribociclib with letrozole vs letrozole alone in elderly patients with hormone receptor-positive, HER2-negative breast cancer in the randomized MONALEESA-2 trial.
    Sonke GS, Hart LL, Campone M, et al. · Breast Cancer Res Treat · 2018 · Background
    PubMed: PMID 29058175 · NCT03944434 (FACILE) · Breast Neoplasms
  5. Gut microbiome influences efficacy of PD-1-based immunotherapy against epithelial tumors.
    Routy B, Le Chatelier E, Derosa L, et al. · Science · 2018 · Background
    PubMed: PMID 29097494 · NCT05163106 (NEOLETRIB) · Breast Neoplasms
  6. NeoPalAna: Neoadjuvant Palbociclib, a Cyclin-Dependent Kinase 4/6 Inhibitor, and Anastrozole for Clinical Stage 2 or 3 Estrogen Receptor-Positive Breast Cancer.
    Ma CX, Gao F, Luo J, et al. · Clin Cancer Res · 2018 · Background
    PubMed: PMID 28270497 · NCT05163106 (NEOLETRIB) · Breast Neoplasms
  7. Preclinical Therapeutic Synergy of MEK1/2 and CDK4/6 Inhibition in Neuroblastoma.
    Hart LS, Rader J, Raman P, et al. · Clin Cancer Res · 2018 · Background
    PubMed: PMID 27729458 · NCT02780128 (NEPENTHE) · Neoplasms
  8. Gut microbiome modulates response to anti-PD-1 immunotherapy in melanoma patients.
    Gopalakrishnan V, Spencer CN, Nezi L, et al. · Science · 2018 · Background
    PubMed: PMID 29097493 · NCT05163106 (NEOLETRIB) · Breast Neoplasms
  9. CDK4/6 inhibition triggers anti-tumour immunity.
    Goel S, DeCristo MJ, Watt AC, et al. · Nature · 2018 · Background
    PubMed: PMID 28813415 · NCT05163106 (NEOLETRIB) · Breast Neoplasms
  10. A Phase I Study of the CDK4/6 Inhibitor Ribociclib (LEE011) in Pediatric Patients with Malignant Rhabdoid Tumors, Neuroblastoma, and Other Solid Tumors.
    Geoerger B, Bourdeaut F, DuBois SG, et al. · Clin Cancer Res · 2018 · Background
    PubMed: PMID 28432176 · NCT02780128 (NEPENTHE) · Neoplasms

2017 (6 papers)

  1. Ribociclib plus letrozole in early breast cancer: A presurgical, window-of-opportunity study.
    Curigliano G, Gómez Pardo P, Meric-Bernstam F, et al. · Breast · 2017 · Derived
    PubMed: PMID 27336726 · NCT01919229 (MONALEESA-1) · Breast Neoplasms
  2. Enrichment of Targetable Mutations in the Relapsed Neuroblastoma Genome.
    Padovan-Merhar OM, Raman P, Ostrovnaya I, et al. · PLoS Genet · 2017 · Background
    PubMed: PMID 27997549 · NCT02780128 (NEPENTHE) · Neoplasms
  3. Targeting ALK With Crizotinib in Pediatric Anaplastic Large Cell Lymphoma and Inflammatory Myofibroblastic Tumor: A Children's Oncology Group Study.
    Mossé YP, Voss SD, Lim MS, et al. · J Clin Oncol · 2017 · Background
    PubMed: PMID 28787259 · NCT02780128 (NEPENTHE) · Neoplasms
  4. CDK4/6 Inhibitors: Promising Opportunities beyond Breast Cancer.
    Lim JS, Turner NC, Yap TA, et al. · Cancer Discov · 2017 · Background
    PubMed: PMID 27371575 · NCT05163106 (NEOLETRIB) · Breast Neoplasms
  5. MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer.
    Goetz MP, Toi M, Campone M, et al. · J Clin Oncol · 2017 · Background
    PubMed: PMID 28968163 · NCT03944434 (FACILE) · Breast Neoplasms
  6. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial.
    Cristofanilli M, Turner NC, Bondarenko I, et al. · Lancet Oncol · 2017 · Background
    PubMed: PMID 26947331 · NCT05163106 (NEOLETRIB) · Breast Neoplasms

2016 (3 papers)

  1. Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer.
    Hortobagyi GN, Stemmer SM, Burris HA, et al. · N Engl J Med · 2016 · Derived
    PubMed: PMID 27717303 · NCT01958021 (MONALEESA-2) · Breast Neoplasms
  2. Palbociclib and Letrozole in Advanced Breast Cancer.
    Finn RS, Martin M, Rugo HS, et al. · N Engl J Med · 2016 · Background
    PubMed: PMID 27959613 · NCT03944434 (FACILE) · Breast Neoplasms
  3. MAP Kinase Inhibition Promotes T Cell and Anti-tumor Activity in Combination with PD-L1 Checkpoint Blockade.
    Ebert PJR, Cheung J, Yang Y, et al. · Immunity · 2016 · Background
    PubMed: PMID 26944201 · NCT05163106 (NEOLETRIB) · Breast Neoplasms

2015 (8 papers)

  1. Cancer and the gut microbiota: an unexpected link.
    Zitvogel L, Galluzzi L, Viaud S, et al. · Sci Transl Med · 2015 · Background
    PubMed: PMID 25609166 · NCT05163106 (NEOLETRIB) · Breast Neoplasms
  2. Anticancer immunotherapy by CTLA-4 blockade relies on the gut microbiota.
    Vétizou M, Pitt JM, Daillère R, et al. · Science · 2015 · Background
    PubMed: PMID 26541610 · NCT05163106 (NEOLETRIB) · Breast Neoplasms
  3. Palbociclib in Hormone-Receptor-Positive Advanced Breast Cancer.
    Turner NC, Ro J, André F, et al. · N Engl J Med · 2015 · Background
    PubMed: PMID 26030518 · NCT05163106 (NEOLETRIB) · Breast Neoplasms
  4. Inhibition of CDK4/6 as a novel therapeutic option for neuroblastoma.
    Rihani A, Vandesompele J, Speleman F, et al. · Cancer Cell Int · 2015 · Background
    PubMed: PMID 26225123 · NCT02780128 (NEPENTHE) · Neoplasms
  5. CDK4/6 inhibitors in luminal breast cancer.
    Gnant M, Steger GG, Bartsch R, et al. · Lancet Oncol · 2015 · Background
    PubMed: PMID 25524801 · NCT05163106 (NEOLETRIB) · Breast Neoplasms
  6. Maintenance capecitabine and bevacizumab versus bevacizumab alone after initial first-line bevacizumab and docetaxel for patients with HER2-negative metastatic breast cancer (IMELDA): a randomised, open-label, phase 3 trial.
    Gligorov J, Doval D, Bines J, et al. · Lancet Oncol · 2015 · Background
    PubMed: PMID 25273343 · NCT03555877 (AMICA)
  7. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study.
    Finn RS, Crown JP, Lang I, et al. · Lancet Oncol · 2015 · Background
    PubMed: PMID 25524798 · NCT03944434 (FACILE) · Breast Neoplasms
  8. ALK mutations confer differential oncogenic activation and sensitivity to ALK inhibition therapy in neuroblastoma.
    Bresler SC, Weiser DA, Huwe PJ, et al. · Cancer Cell · 2015 · Background
    PubMed: PMID 25517749 · NCT02780128 (NEPENTHE) · Neoplasms

2014 (1 paper)

  1. Dual CDK4/CDK6 inhibition induces cell-cycle arrest and senescence in neuroblastoma.
    Rader J, Russell MR, Hart LS, et al. · Clin Cancer Res · 2014 · Background
    PubMed: PMID 24045179 · NCT02780128 (NEPENTHE) · Neoplasms

2013 (4 papers)

  1. The intestinal microbiota modulates the anticancer immune effects of cyclophosphamide.
    Viaud S, Saccheri F, Mignot G, et al. · Science · 2013 · Background
    PubMed: PMID 24264990 · NCT05163106 (NEOLETRIB) · Breast Neoplasms
  2. Safety and activity of crizotinib for paediatric patients with refractory solid tumours or anaplastic large-cell lymphoma: a Children's Oncology Group phase 1 consortium study.
    Mossé YP, Lim MS, Voss SD, et al. · Lancet Oncol · 2013 · Background
    PubMed: PMID 23598171 · NCT02780128 (NEPENTHE) · Neoplasms
  3. Phase II trial of the CDK4 inhibitor PD0332991 in patients with advanced CDK4-amplified well-differentiated or dedifferentiated liposarcoma.
    Dickson MA, Tap WD, Keohan ML, et al. · J Clin Oncol · 2013 · Background
    PubMed: PMID 23569312 · NCT02571829 · Liposarcoma
  4. Feasibility of MR metabolomics for immediate analysis of resection margins during breast cancer surgery.
    Bathen TF, Geurts B, Sitter B, et al. · PLoS One · 2013 · Background
    PubMed: PMID 23613877 · NCT05163106 (NEOLETRIB) · Breast Neoplasms

2012 (2 papers)

  1. Presurgical (neoadjuvant) endocrine therapy is a useful model to predict response and outcome to endocrine treatment in breast cancer patients.
    Geisler J, Smith I, Miller W, et al. · J Steroid Biochem Mol Biol · 2012 · Background
    PubMed: PMID 22207086 · NCT05163106 (NEOLETRIB) · Breast Neoplasms
  2. Differential inhibitor sensitivity of anaplastic lymphoma kinase variants found in neuroblastoma.
    Bresler SC, Wood AC, Haglund EA, et al. · Sci Transl Med · 2012 · Background
    PubMed: PMID 22072639 · NCT02780128 (NEPENTHE) · Neoplasms

2011 (1 paper)

  1. Functional analysis of the p53 pathway in neuroblastoma cells using the small-molecule MDM2 antagonist nutlin-3.
    Van Maerken T, Rihani A, Dreidax D, et al. · Mol Cancer Ther · 2011 · Background
    PubMed: PMID 21460101 · NCT02780128 (NEPENTHE) · Neoplasms

2010 (4 papers)

  1. Functional genetic polymorphisms in the aromatase gene CYP19 vary the response of breast cancer patients to neoadjuvant therapy with aromatase inhibitors.
    Wang L, Ellsworth KA, Moon I, et al. · Cancer Res · 2010 · Background
    PubMed: PMID 20048079 · NCT05163106 (NEOLETRIB) · Breast Neoplasms
  2. Escape from p53-mediated tumor surveillance in neuroblastoma: switching off the p14(ARF)-MDM2-p53 axis.
    Van Maerken T, Vandesompele J, Rihani A, et al. · Cell Death Differ · 2010 · Background
    PubMed: PMID 19779493 · NCT02780128 (NEPENTHE) · Neoplasms
  3. High Frequency of p53/MDM2/p14ARF Pathway Abnormalities in Relapsed Neuroblastoma.
    Carr-Wilkinson J, O'Toole K, Wood KM, et al. · Clin Cancer Res · 2010 · Background
    PubMed: PMID 20145180 · NCT02780128 (NEPENTHE) · Neoplasms
  4. Subtype-specific genomic alterations define new targets for soft-tissue sarcoma therapy.
    Barretina J, Taylor BS, Banerji S, et al. · Nat Genet · 2010 · Background
    PubMed: PMID 20601955 · NCT02571829 · Liposarcoma

2008 (3 papers)

  1. Identification of ALK as a major familial neuroblastoma predisposition gene.
    Mossé YP, Laudenslager M, Longo L, et al. · Nature · 2008 · Background
    PubMed: PMID 18724359 · NCT02780128 (NEPENTHE) · Neoplasms
  2. Letrozole is superior to anastrozole in suppressing breast cancer tissue and plasma estrogen levels.
    Geisler J, Helle H, Ekse D, et al. · Clin Cancer Res · 2008 · Background
    PubMed: PMID 18829517 · NCT05163106 (NEOLETRIB) · Breast Neoplasms
  3. Outcome prediction for estrogen receptor-positive breast cancer based on postneoadjuvant endocrine therapy tumor characteristics.
    Ellis MJ, Tao Y, Luo J, et al. · J Natl Cancer Inst · 2008 · Background
    PubMed: PMID 18812550 · NCT05163106 (NEOLETRIB) · Breast Neoplasms

2007 (2 papers)

  1. Proposal for standardized definitions for efficacy end points in adjuvant breast cancer trials: the STEEP system.
    Hudis CA, Barlow WE, Costantino JP, et al. · J Clin Oncol · 2007 · Trial result
    PubMed: PMID 17513820 · NCT03078751 (EarLEE-1) · Breast Neoplasms
  2. Phase 2 randomized trial of primary endocrine therapy versus chemotherapy in postmenopausal patients with estrogen receptor-positive breast cancer.
    Semiglazov VF, Semiglazov VV, Dashyan GA, et al. · Cancer · 2007 · Background
    PubMed: PMID 17538978 · NCT05163106 (NEOLETRIB) · Breast Neoplasms

2006 (1 paper)

  1. Cyclin-dependent kinase pathways as targets for cancer treatment.
    Shapiro GI · J Clin Oncol · 2006 · Background
    PubMed: PMID 16603719 · NCT02571829 · Liposarcoma

2005 (1 paper)

  1. Neoadjuvant treatment of postmenopausal breast cancer with anastrozole, tamoxifen, or both in combination: the Immediate Preoperative Anastrozole, Tamoxifen, or Combined with Tamoxifen (IMPACT) multicenter double-blind randomized trial.
    Smith IE, Dowsett M, Ebbs SR, et al. · J Clin Oncol · 2005 · Background
    PubMed: PMID 15998903 · NCT05163106 (NEOLETRIB) · Breast Neoplasms

2002 (3 papers)

  1. Progression-free rate as the principal end-point for phase II trials in soft-tissue sarcomas.
    Van Glabbeke M, Verweij J, Judson I, et al. · Eur J Cancer · 2002 · Background
    PubMed: PMID 11872347 · NCT02571829 · Liposarcoma
  2. Cyclin D-dependent kinases, INK4 inhibitors and cancer.
    Ortega S, Malumbres M, Barbacid M, et al. · Biochim Biophys Acta · 2002 · Background
    PubMed: PMID 11960696 · NCT02571829 · Liposarcoma
  3. Influence of letrozole and anastrozole on total body aromatization and plasma estrogen levels in postmenopausal breast cancer patients evaluated in a randomized, cross-over study.
    Geisler J, Haynes B, Anker G, et al. · J Clin Oncol · 2002 · Background
    PubMed: PMID 11821457 · NCT05163106 (NEOLETRIB) · Breast Neoplasms

2001 (1 paper)

  1. Influence of neoadjuvant anastrozole (Arimidex) on intratumoral estrogen levels and proliferation markers in patients with locally advanced breast cancer.
    Geisler J, Detre S, Berntsen H, et al. · Clin Cancer Res · 2001 · Background
    PubMed: PMID 11350888 · NCT05163106 (NEOLETRIB) · Breast Neoplasms

1998 (1 paper)

  1. In vivo inhibition of aromatization by exemestane, a novel irreversible aromatase inhibitor, in postmenopausal breast cancer patients.
    Geisler J, King N, Anker G, et al. · Clin Cancer Res · 1998 · Background
    PubMed: PMID 9748124 · NCT05163106 (NEOLETRIB) · Breast Neoplasms

1996 (1 paper)

  1. Influence of anastrozole (Arimidex), a selective, non-steroidal aromatase inhibitor, on in vivo aromatisation and plasma oestrogen levels in postmenopausal women with breast cancer.
    Geisler J, King N, Dowsett M, et al. · Br J Cancer · 1996 · Background
    PubMed: PMID 8883419 · NCT05163106 (NEOLETRIB) · Breast Neoplasms

1988 (1 paper)

  1. A surprising finding by a surgery for lumbar intervertebral disk herniation--Ewing's sarcoma.
    Kala M, Chrobok J, Dvorák P, et al. · Acta Univ Palacki Olomuc Fac Med · 1988 · Background
    PubMed: PMID 2963494 · NCT05163106 (NEOLETRIB) · Breast Neoplasms

1985 (1 paper)

  1. Parietal cell protein kinases. Selective activation of type I cAMP-dependent protein kinase by histamine.
    Chew CS · J Biol Chem · 1985 · Background
    PubMed: PMID 2987257 · NCT05163106 (NEOLETRIB) · Breast Neoplasms

Sources and methodology

This page summarizes published evidence for general reference and does not constitute medical advice. For clinical decisions, consult the linked primary publications and your healthcare provider. Data sourced from PubMed and the ClinicalTrials.gov / AACT database maintained by the Clinical Trials Transformation Initiative (CTTI).