Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023;73:17–48.

Article  PubMed  Google Scholar 

Goetz MP, Toi M, Campone M, Sohn J, Paluch-Shimon S, Huober J, et al. MONARCH 3: abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 2017;35:3638–46.

Article  CAS  PubMed  Google Scholar 

Sherr CJ, Roberts JM. CDK inhibitors: positive and negative regulators of G1-phase progression. Genes Dev. 1999;13:1501–12.

Article  CAS  PubMed  Google Scholar 

Bertoli C, Skotheim JM, de Bruin RA. Control of cell cycle transcription during G1 and S phases. Nat Rev Mol Cell Biol. 2013;14:518–28.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Spring LM, Wander SA, Andre F, Moy B, Turner NC, Bardia A. Cyclin-dependent kinase 4 and 6 inhibitors for hormone receptor-positive breast cancer: past, present, and future. Lancet. 2020;395:817–27.

Article  CAS  PubMed  Google Scholar 

Ding L, Cao J, Lin W, Chen H, Xiong X, Ao H, et al. The roles of cyclin-dependent kinases in cell-cycle progression and therapeutic strategies in human breast cancer. Int J Mol Sci. 2020;21:1960.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Roskoski R Jr. Cyclin-dependent protein serine/threonine kinase inhibitors as anticancer drugs. Pharm Res. 2019;139:471–88.

Article  CAS  Google Scholar 

Pernas S, Tolaney SM, Winer EP, Goel S. CDK4/6 inhibition in breast cancer: current practice and future directions. Ther Adv Med Oncol. 2018;10:1758835918786451.

Article  PubMed  PubMed Central  Google Scholar 

Alves CL, Ehmsen S, Terp MG, Portman N, Tuttolomondo M, Gammelgaard OL, et al. Co-targeting CDK4/6 and AKT with endocrine therapy prevents progression in CDK4/6 inhibitor and endocrine therapy-resistant breast cancer. Nat Commun. 2021;12:5112.

Article  ADS  CAS  PubMed  PubMed Central  Google Scholar 

Xu B. Dalpiciclib in advanced breast cancer: introducing CDK4/6 inhibitors as a first-line treatment might not be the best strategy - Author’s reply. Lancet Oncol. 2023;24:e357.

Article  CAS  PubMed  Google Scholar 

Lelliott EJ, Kong IY, Zethoven M, Ramsbottom KM, Martelotto LG, Meyran D, et al. CDK4/6 inhibition promotes antitumor immunity through the induction of T-cell memory. Cancer Discov. 2021;11:2582–601.

Article  CAS  PubMed  Google Scholar 

Goel S, DeCristo MJ, Watt AC, BrinJones H, Sceneay J, Li BB, et al. CDK4/6 inhibition triggers anti-tumour immunity. Nature. 2017;548:471–5.

Article  ADS  CAS  PubMed  PubMed Central  Google Scholar 

Schettini F, Giuliano M, Giudici F, Conte B, De Placido P, Venturini S, et al. Endocrine-based treatments in clinically-relevant subgroups of hormone receptor-positive/HER2-negative metastatic breast cancer: systematic review and meta-analysis. Cancers (Basel). 2021;13:1458.

Article  CAS  PubMed  Google Scholar 

Wang J, Han Y, Wang J, Li Q, Xu B. Endocrine therapy-based strategies for metastatic breast cancer with different endocrine sensitivity statuses: a systematic review and network meta-analysis. Cancers (Basel). 2022;14:6100.

Article  CAS  PubMed  Google Scholar 

Lukas J, Bartkova J, Bartek J. Convergence of mitogenic signalling cascades from diverse classes of receptors at the cyclin D-cyclin-dependent kinase-pRb-controlled G1 checkpoint. Mol Cell Biol. 1996;16:6917–25.

Article  CAS  PubMed  PubMed Central  Google Scholar 

De Marchi T, Foekens JA, Umar A, Martens JW. Endocrine therapy resistance in estrogen receptor (ER)-positive breast cancer. Drug Discov Today. 2016;21:1181–8.

Article  PubMed  Google Scholar 

Rugo HS, Rumble RB, Macrae E, Barton DL, Connolly HK, Dickler MN, et al. Endocrine therapy for hormone receptor-positive metastatic breast cancer: American Society of Clinical Oncology Guideline. J Clin Oncol. 2016;34:3069–103.

Article  CAS  PubMed  Google Scholar 

Finn RS, Martin M, Rugo HS, Jones S, Im SA, Gelmon K, et al. Palbociclib and letrozole in advanced breast cancer. N Engl J Med. 2016;375:1925–36.

Article  CAS  PubMed  Google Scholar 

Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N. Engl J Med. 2016;375:1738–48.

Article  CAS  PubMed  Google Scholar 

Brett JO, Spring LM, Bardia A, Wander SA. ESR1 mutation as an emerging clinical biomarker in metastatic hormone receptor-positive breast cancer. Breast Cancer Res. 2021;23:85.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Bardia A, Hurvitz S. Targeted therapy for premenopausal women with HR(+), HER2(-) advanced breast cancer: focus on special considerations and latest advances. Clin Cancer Res. 2018;24:5206–18.

Article  CAS  PubMed  Google Scholar 

Tripathy D, Im SA, Colleoni M, Franke F, Bardia A, Harbeck N, et al. Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial. Lancet Oncol. 2018;19:904–15.

Article  CAS  PubMed  Google Scholar 

Im SA, Lu YS, Bardia A, Harbeck N, Colleoni M, Franke F, et al. Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer. N. Engl J Med. 2019;381:307–16.

Article  CAS  PubMed  Google Scholar 

Zhang P, Zhang Q, Tong Z, Sun T, Li W, Ouyang Q, et al. Dalpiciclib plus letrozole or anastrozole versus placebo plus letrozole or anastrozole as first-line treatment in patients with hormone receptor-positive, HER2-negative advanced breast cancer (DAWNA-2): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2023;24:646–57.

Article  CAS  PubMed  Google Scholar 

Slamon DJ, Neven P, Chia S, Fasching PA, De Laurentiis M, Im SA, et al. Phase III randomized study of ribociclib and fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: MONALEESA-3. J Clin Oncol. 2018;36:2465–72.

Article  CAS  PubMed  Google Scholar 

Slamon DJ, Neven P, Chia S, Jerusalem G, De Laurentiis M, Im S, et al. 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. Ann Oncol. 2021;32:1015–24.

Article  CAS  PubMed  Google Scholar 

Slamon DJ, Neven P, Chia S, Fasching PA, De Laurentiis M, Im SA, et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N. Engl J Med. 2020;382:514–24.

Article  CAS  PubMed  Google Scholar 

Slamon DJ, Neven P, Chia S, Fasching PA, De Laurentiis M, Im SA, et al. Overall survival (OS) results of the phase III MONALEESA-3 trial of postmenopausal patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor 2-negative (HER2-) advanced breast cancer (ABC) treated with fulvestrant (FUL) ± ribociclib (RIB). Ann Oncol. 2019;30:v856–v7.

Article  Google Scholar 

Albanell J, Martínez MT, Ramos M, O’Connor M, de la Cruz-Merino L, Santaballa A, et al. Randomized phase II study of fulvestrant plus palbociclib or placebo in endocrine-sensitive, hormone receptor-positive/HER2-advanced breast cancer: GEICAM/2014-12 (FLIPPER). Eur J Cancer. 2022;161:26–37.

Article  ADS  CAS  PubMed  Google Scholar 

Tibau A, Martínez MT, Ramos M, De La Cruz-Merino L, Santaballa A, O’Connor M, et al. Quality of life with palbociclib plus fulvestrant versus placebo plus fulvestrant in postmenopausal women with endocrine-sensitive hormone receptor-positive and HER2-negative advanced breast cancer: patient-reported outcomes from the FLIPPER trial. Ther Adv Med Oncol. 2023;15:17588359221148921.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Llombart-Cussac A, Pérez-García JM, Bellet M, Dalenc F, Gil-Gil M, Ruíz-Borrego M, et al. Fulvestrant-palbociclib vs letrozole-palbociclib as initial therapy for endocrine-sensitive, hormone receptor-positive, ERBB2-negative advanced breast cancer: a randomized clinical trial. JAMA Oncol. 2021;7:1791–9.

Article  PubMed  Google Scholar 

Di Cosimo S, Pérez-García JM, Bellet M, Dalenc F, Gil Gil MJ, Ruiz Borrego M, et al. Palbociclib with fulvestrant or letrozole in endocrine-sensitive patients with HR-positive/HER2-negative advanced breast cancer: a detailed safety analysis of the randomized PARSIFAL Trial. Oncologist. 2023;28:23–32.

Article  PubMed  Google Scholar 

Sledge GW Jr, Toi M, Neven P, Sohn J, Inoue K, Pivot X, et al. The effect of abemaciclib plus fulvestrant on overall survival in hormone receptor-positive, ERBB2-negative breast cancer that progressed on endocrine therapy-MONARCH 2: a randomized clinical trial. JAMA Oncol. 2020;6:116–24.

Article  PubMed  Google Scholar 

Zhang QY, Sun T, Yin YM, Li HP, Yan M, Tong ZS, et al. MONARCH plus: abemaciclib plus endocrine therapy in women with HR+/HER2- advanced breast cancer: the multinational randomized phase III study. Ther Adv Med Oncol. 2020;12:1758835920963925.

Article  CAS  PubMed  PubMed Central