Drug updated on 11/10/2023

Dosage FormCapsule (oral; 75 mg, 100 mg, 125 mg); Tablet (oral; 75 mg, 100 mg, 125 mg)
Drug ClassKinase inhibitors
Ongoing and Completed


  • For the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men; or fulvestrant in patients with disease progression following endocrine therapy.

Product Monograph / Prescribing Information

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Safety profile of cyclin-dependent kinase (CDK) 4/6 inhibitors with concurrent radiation therapy: A systematic review and meta-analysis2023Cancer treatment reviews
Second-line Endocrine Therapy of Hormone Receptor-positive/HER2- negative Advanced Breast Cancer: A Systematic Review and Network Meta-analysis2023Current cancer drug targets
An Overview of the Safety Profile and Clinical Impact of CDK4/6 Inhibitors in Breast Cancer-A Systematic Review of Randomized Phase II and III Clinical Trials2023Biomolecules
Impact of CDK4/6 Inhibitors on Aromatase Inhibitor-Associated Musculoskeletal Syndrome (AIMSS) in the Adjuvant Setting2023The breast journal
The likelihood of being helped or harmed as a patient-centred tool to assess cyclin dependent kinase 4/6 inhibitors clinical impact and safety in metastatic breast cancer: a systematic review and sensitivity-analysis2023EClinicalMedicine
Health-related quality of life in breast cancer patients treated with CDK4/6 inhibitors: a systematic review2022ESMO open
Pharmacoeconomic evaluations of CDK4/6 inhibitors plus endocrine therapy for advanced hormone receptor-positive (HR+) and human epidermal growth factor receptor-2 negative (HER2-) breast cancer: a systematic review2022Annals of translational medicine
Progression-Free Survival and Overall Survival of CDK 4/6 Inhibitors Plus Endocrine Therapy in Metastatic Breast Cancer: A Systematic Review and Meta-Analysis2022International journal of molecular sciences
CDK4/6 inhibitors in HR+/HER2- advanced/metastatic breast cancer: a systematic literature review of real-world evidence studies.2021Future Oncology
Oral adverse effects of CDK4/6 inhibitors among breast cancer patients: a systematic review and meta-analysis.2021Annals of Palliative Medicine
Emerging skin toxicities in patients with breast cancer treated with new cyclin dependent kinase 4/6 inhibitors: a systematic review.2021Drug Safety
Efficacy and safety of CDK4/6 and PI3K/AKT/mTOR inhibitors as second-line treatment in postmenopausal patients with hormone receptor-positive, HER-2-negative metastatic breast cancer: a network meta-analysis2021Expert opinion on drug safety
Comparison of endocrine therapies in hormone receptor-positive and human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer: a network meta-analysis.2020Journal of Breast Cancer
Comparison of treatment-related adverse events of different cyclindependent kinase 4/6 inhibitors in metastatic breast cancer: a network meta-analysis.2020Cancer Treatment Reviews
CDK4/6 inhibitors in breast cancer: differences in toxicity profiles and impact on agent choice. A systematic review and meta-analysis.2020Expert Review of Anticancer Therapy
Endocrine therapies in postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative, pretreated, advanced breast cancer: a network meta-analysis.2020Medicine
Cyclin‑dependent kinase 4/6 inhibitors in combination with fulvestrant for previously treated metastatic hormone receptor‑positive breast cancer patients: A systematic review and meta‑analysis of randomized clinical trials2020Cancer treatment and research
Venous thromboembolism risk in patients with hormone receptor-positive HER2-negative metastatic breast cancer treated with combined CDK 4/6 inhibitors plus endocrine therapy versus endocrine therapy alone: a systematic review and meta-analysis of randomized controlled trials2020Breast cancer research and treatment
Final clinical guidance report: palbociclib (Ibrance) with fulvestrant for metastatic breast cancer. 2019CADTH
Endocrine treatment versus chemotherapy in postmenopausal women with hormone receptor-positive, HER2-negative, metastatic breast cancer: a systematic review and network meta-analysis.2019The Lancet Oncology
Systematic literature review of clinical trials of endocrine therapies for premenopausal women with metastatic HR+ HER2- breast cancer2019The breast journal
Treatment of advanced HR+/HER2- breast cancer with new targeted agents in combination with endocrine therapy: a review of efficacy and tolerability based on available randomized trials on everolimus, ribociclib, palbociclib and abemaciclib2019Acta oncologica
Comparative Efficacy of CDK4/6 Inhibitors Plus Aromatase Inhibitors Versus Fulvestrant for the First-Line Treatment of Hormone Receptor-Positive Advanced Breast Cancer: A Network Meta-Analysis2019Targeted oncology
Progression-free Survival With First-line Endocrine-based Therapies Among Postmenopausal Women With HR+/HER2- Metastatic Breast Cancer:: A Network Meta-analysis2018Clinical therapeutics
CDK4/6 inhibitors in advanced hormone receptor-positive/HER2-negative breast cancer: a systematic review and meta-analysis of randomized trials2018Breast cancer research and treatment
Systematic review and network meta-analysis comparing palbociclib with chemotherapy agents for the treatment of postmenopausal women with HR-positive and HER2-negative advanced/metastatic breast cancer. 2017Breast Cancer Research and Treatment
Comparison of palbociclib in combination with letrozole or fulvestrant with endocrine therapies for advanced/metastatic breast cancer: network meta-analysis2017Current medical research and opinion

Clinical Practice Guidelines

Document TitleYearSource
NCCN guidelines updates: breast cancer.2018Journal of the National Comprehensive Cancer Network