References
- Slamon DJ, Neven P, Chia 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. doi:10.1016/j.annonc.2021.05.353
- Hortobagyi GN, Stemmer SM, Burris HA, et al. Overall survival results from the phase III MONALEESA-2 trial of postmenopausal patients with HR+/HER2- advanced breast cancer treated with endocrine Therapy ± Ribociclib. Presented at: ESMO Congress; September 16–21; 2021.
- Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med. 2016;375(18):1738–1748. doi:10.1056/NEJMoa1609709
- Tripathy D, Im SA, Colleoni M, 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(7):904–915. doi:10.1016/S1470-2045(18)30292-4
- Hortobagyi GN, Stemmer SM, Burris HA, et al. 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. Ann Oncol. 2018;29(7):1541–1547. doi:10.1093/annonc/mdy155
- Hortobagyi GN. Ribociclib for the first-line treatment of advanced hormone receptor- positive breast cancer: a review of subgroup analyses from the MONALEESA-2 trial. Breast Cancer Res. 2018;20(1):123. doi:10.1186/s13058-018-1050-7
- Yardley D, Chan A, Nusch A, et al. Ribociclib plus endocrine therapy in patients with hormone receptor-positive, HER2-negative advanced breast cancer presenting with visceral metastases: subgroup analysis of Phase 3 MONALEESA trials. Presented at: San Antonio Breast Cancer Symposium; San Antonio, TX, USA; 4–8 December; 2018.
- Blackwell KL, Paluch-Shimon S, Campone M, et al. Subsequent treatment for postmenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer who received ribociclib + letrozole vs placebo + letrozole in the Phase III MONALEESA-2 study. Presented at: San Antonio Breast Cancer Symposium; TX, USA; 5–9 December; 2017.
- Janni W, Alba E, Bachelot T, et al. 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. Breast Cancer Res Treat. 2018;169(3):469–479.
- Lu YS, Im SA, Colleoni M, et al. 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. Clin Cancer Res. 2021;4:54
- Yardley DA. MONALEESA clinical program: a review of ribociclib use in different clinical settings. Future Oncol. 2019;15(23):2673–2686. doi:10.2217/fon-2019-0130
- Leung JH, Leung HWC, Wang SY, Huang SS, Chan ALF. 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-analysis. Expert Opin Drug Saf. 2021;20(8):949–957. PMID: 34047239. doi:10.1080/14740338.2021.1931116
- Verma S, O’Shaughnessy J, Burris HA, et al. Health-related quality of life of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer treated with ribociclib + letrozole: results from MONALEESA-2. Breast Cancer Res Treat. 2018;170(3):535–545. doi:10.1007/s10549-018-4769-z
- Harbeck N, Villanueva Vazquez R, Tripathy D, et al. Ribociclib (RIB) plus tamoxifen (TAM) or a non-steroidal aromatase inhibitor (NSAI) in premenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (ABC): additional results from the MONALEESA-7 trial. Eur J Cancer. 2018;92(Suppl3):S1.
- Giuliano M, Schettini F, Rognoni C, et al. Endocrine treatment versus chemotherapy in postmenopausal women with hormone receptor-positive, HER2-negative, metastatic breast cancer: a systematic review and network meta-analysis. Lancet Oncol. 2019;20(10):1360–1369. PMID: 31494037. doi: 10.1016/S1470-2045(19)30420-6
- De Laurentiis M, Borstnar S, Campone M, et al. 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. Breast Cancer Res Treat. 2021;189(3):689–699. doi:10.1007/s10549-021-06334-0
- Murphy CG. The role of CDK4/6 inhibitors in breast cancer. Curr Treat Options Oncol. 2019;20(6):52. doi:10.1007/s11864-019-0651-4
- Goel S, Pernas S, Tan-Wasielewski Z, et al. Ribociclib plus trastuzumab in advanced HER2-positive breast cancer: results of a phase 1b/2 trial. Clin Breast Cancer. 2019;19(6):399–404. doi:10.1016/j.clbc.2019.05.010
- Spring LM, Clark SL, Li T, et al. Phase 1b clinical trial of Ado-Trastuzumab emtansine and ribociclib for HER2-positive metastatic breast cancer. NPJ Breast Cancer. 2021;7(1):103. doi:10.1038/s41523-021-00311-y
- Modi S, Saura C, Yamashita T, et al. Trastuzumab deruxtecan in previously treated HER2-positive breast cancer. N Engl J Med. 2020;382(7):610–621. doi:10.1056/NEJMoa1914510
- André F, Ciruelos E, Rubovszky G, et al. Alpelisib for PIK3CA-mutated, hormone receptor-positive advanced breast cancer. N Engl J Med. 2019;380(20):1929–1940. doi:10.1056/NEJMoa1813904
- Schettini F, Buono G, Trivedi MV, et al. PI3K/mTOR inhibitors in the treatment of luminal breast cancer. Why, When and to Whom? Breast Care. 2017;12(5):290–294. doi:10.1159/000481657
- Tolaney SM, Im YH, Calvo E, et al. Phase Ib study of ribociclib plus fulvestrant and ribociclib plus fulvestrant plus PI3K inhibitor (Alpelisib or Buparlisib) for HR+ advanced breast cancer. Clin Cancer Res. 2021;27(2):418–428. doi:10.1158/1078-0432.CCR-20-0645
- Goel S, DeCristo MJ, Watt AC, et al. CDK4/6 inhibition triggers anti-tumour immunity. Nature. 2017;548(7668):471–475. doi:10.1038/nature23465
- Deng J, Wang ES, Jenkins RW, et al. CDK4/6 inhibition augments antitumor immunity by enhancing T-cell activation. Cancer Discov. 2018;8(2):216–233. doi:10.1158/2159-8290.CD-17-0915
- Fribbens C, O’Leary B, Kilburn L, et al. Plasma ESR1 mutations and the treatment of estrogen receptor-positive advanced breast cancer. J Clin Oncol. 2016;34(25):2961–2968. PMID: 27269946. doi:10.1200/JCO.2016.67.3061
- Peuker CA, Yaghobramzi S, Grunert C, et al. Treatment with ribociclib shows favourable immunomodulatory effects in patients with hormone receptor-positive breast cancer-findings from the RIBECCA trial. Eur J Cancer. 2022;162:45–55. doi:10.1016/j.ejca.2021.11.025
- Pembrolizumab, Letrozole, and Palbociclib in treating postmenopausal patients with newly diagnosed metastatic stage IV estrogen receptor positive breast cancer. Available from: https://clinicaltrials.gov/ct2/show/NCT02778685. Accessed January 12, 2022.
- Ameratunga M, Kipps E, Okines AFC, et al. To cycle or fight-CDK4/6 inhibitors at the crossroads of anticancer immunity. Clin Cancer Res. 2019;25(1):21–28. doi:10.1158/1078-0432.CCR-18-1999
- Spring L, Griffin C, Isakoff SJ, et al. Phase II study of adjuvant endocrine therapy with CDK 4/6 inhibitor, ribociclib, for localized ER+/HER2- breast cancer (LEADER). J Clin Oncol. 2020;38:531. doi:10.1200/jco.2020.38.15_suppl.531
- Burris HA, Chan A, Bardia A, et al. 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. Br J Cancer. 2021;125(5):679–686. doi:10.1038/s41416-021-01415-9
- Haddad TC, Goetz MP. Landscape of neoadjuvant therapy for breast cancer. Ann Surg Oncol. 2015;22:1408–1415. doi:10.1245/s10434-015-4405-7
- Curigliano G, Gomez Pardo P, Meric-Bernstam F, et al. Ribociclib plus letrozole in early breast cancer: a presurgical window-of-opportunity study. Breast. 2016;25:191–198. doi:10.1016/j.breast.2016.06.008
- Khan Q. Letrozole plus ribociclib or placebo as neoadjuvant therapy in ER-positive, HER2-negative. Proc Am Soc. 2020;abs 505.
- Wallden B, Storhoff J, Nielsen T, et al. Development and verification of the PAM50-based Prosigna breast cancer gene signature assay. BMC Med Genomics. 2015;8:54. doi:10.1186/s12920-015-0129-6
- Prat A, Saura C, Tomás Pascual C, et al. Ribociclib plus letrozole versus chemotherapy for postmenopausal women with hormone receptor-positive, HER2-negative, luminal B breast cancer, CORALLEEN. Lancet. 2020;21(1):33–43. doi:10.1016/S1470-2045(19)30786-7