Bray F, et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394–424.
Article
PubMed
Google Scholar
National Cancer Institute, Surveillance, Epidemiology, and End Results Program, Cancer Stat Facts: Female Breast Cancer; available at https://seer.cancer.gov/statfacts/html/breast.html. Accessed 16 Sept 2022.
American Cancer Society. Cancer Facts & Figures 2022. Atlanta, Ga: American Cancer Society; 2022.
Cardoso F, et al. 1st International consensus guidelines for advanced breast cancer (ABC 1). Breast. 2012;21(3):242–52.
Article
CAS
PubMed
Google Scholar
Pan H, et al. 20-Year Risks of Breast-Cancer Recurrence after Stopping Endocrine Therapy at 5 Years. N Engl J Med. 2017;377(19):1836–46.
Article
PubMed
PubMed Central
Google Scholar
Howlader N, et al. US incidence of breast cancer subtypes defined by joint hormone receptor and HER2 status. J Natl Cancer Inst. 2014;106(5):dju055.
Article
PubMed
PubMed Central
Google Scholar
Cancer Genome Atlas N. Comprehensive molecular portraits of human breast tumours. Nature. 2012;490(7418):61–70.
Article
CAS
Google Scholar
Sabine VS, et al. Mutational analysis of PI3K/AKT signaling pathway in tamoxifen exemestane adjuvant multinational pathology study. J Clin Oncol. 2014;32(27):2951–8.
Article
CAS
PubMed
Google Scholar
Thorpe LM, Yuzugullu H, Zhao JJ. PI3K in cancer: divergent roles of isoforms, modes of activation and therapeutic targeting. Nat Rev Cancer. 2015;15(1):7–24.
Article
CAS
PubMed
PubMed Central
Google Scholar
Rodon J, et al. Development of PI3K inhibitors: lessons learned from early clinical trials. Nat Rev Clin Oncol. 2013;10(3):143–53.
Article
CAS
PubMed
Google Scholar
Mukohara T. PI3K mutations in breast cancer: prognostic and therapeutic implications. Breast Cancer (Dove Med Press). 2015;7:111–23.
Google Scholar
André F, et al. Alpelisib for PIK3CA-Mutated, Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2019;380(20):1929–40.
Article
PubMed
Google Scholar
Baselga J, Dent SF, Cortés J, Im Y-H, Diéras V, Harbeck N, et al. Phase III study of taselisib (GDC-0032) + fulvestrant (FULV) v FULV in patients (pts) with estrogen receptor (ER)-positive, PIK3CA-mutant (MUT), locally advanced or metastatic breast cancer (MBC): Primary analysis from SANDPIPER. J Clin Oncol. 2018;36(18_suppl):LBA1006.
Janku F, Yap TA, Meric-Bernstam F. Targeting the PI3K pathway in cancer: are we making headway? Nat Rev Clin Oncol. 2018;15(5):273–91.
Article
CAS
PubMed
Google Scholar
Baselga J, et al. Buparlisib plus fulvestrant versus placebo plus fulvestrant in postmenopausal, hormone receptor-positive, HER2-negative, advanced breast cancer (BELLE-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2017;18(7):904–16.
Article
CAS
PubMed
PubMed Central
Google Scholar
Mollon LE, et al. A Systematic Literature Review of the Prognostic and Predictive Value of PIK3CA Mutations in HR+/HER2− Metastatic Breast Cancer. Clin Breast Cancer. 2020;20(3):e232–43.
Article
CAS
PubMed
Google Scholar
Hodi FS, et al. Imatinib for melanomas harboring mutationally activated or amplified KIT arising on mucosal, acral, and chronically sun-damaged skin. J Clin Oncol. 2013;31(26):3182–90.
Article
CAS
PubMed
PubMed Central
Google Scholar
Andre F, Ciruelos EM, Juric D, Loibl S, Campone M, Mayer IA, Rubovszky G, Yamashita T, Kaufman B, Lu YS, et al. Alpelisib plus fulvestrant for PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: final overall survival results from SOLAR-1. Ann Oncol. 2021;32(2):208–17.
Article
CAS
PubMed
Google Scholar
Juric D, Loibl S, Andre F, Mingorance JID, Forget F, Levy C, Masuda N, Campone M, Conte PF, Iwata H, et al. Alpelisib (ALP) with fulvestrant (FUL) in patients (pts) with PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor-2-negative (HER2-) advanced breast cancer (ABC): Primary or secondary resistance to prior endocrine therapy (ET) in the SOLAR-1 trial. Clin Oncol. 2019;37(Suppl 15):1038–1038.
Google Scholar
Campone M, Im SA, Iwata H, Clemons M, Ito Y, Awada A, Chia S, Jagiello-Gruszfeld A, Pistilli B, Tseng LM, et al. Buparlisib plus fulvestrant versus placebo plus fulvestrant for postmenopausal, hormone receptor-positive, human epidermal growth factor receptor 2-negative, advanced breast cancer: Overall survival results from BELLE-2. Eur J Cancer. 2018;103:147–54.
Article
CAS
PubMed
Google Scholar
Cristofanilli M, Turner NC, Bondarenko I, Ro J, Im SA, Masuda N, Colleoni M, DeMichele A, Loi S, Verma S, et al. 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. Lancet Oncol. 2016;17(4):425–39.
Article
CAS
PubMed
Google Scholar
Turner NC, Slamon DJ, Ro J, Bondarenko I, Im SA, Masuda N, Colleoni M, DeMichele A, Loi S, Verma S, et al. Overall Survival with Palbociclib and Fulvestrant in Advanced Breast Cancer. N Engl J Med. 2018;379(20):1926–36.
Article
CAS
PubMed
Google Scholar
Di Leo A, Johnston S, Lee KS, Ciruelos E, Lonning PE, Janni W, O’Regan R, Mouret-Reynier MA, Kalev D, Egle D, et al. Buparlisib plus fulvestrant in postmenopausal women with hormone-receptor-positive, HER2-negative, advanced breast cancer progressing on or after mTOR inhibition (BELLE-3): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2018;19(1):87–100.
Dickler MN, Saura C, Richards DA, Krop IE, Cervantes A, Bedard PL, Patel MR, Pusztai L, Oliveira M, Cardenas AK, et al. Phase II Study of Taselisib (GDC-0032) in Combination with Fulvestrant in Patients with HER2-Negative, Hormone Receptor-Positive Advanced Breast Cancer. Clin Cancer Res. 2018;24(18):4380–7.
Article
CAS
PubMed
PubMed Central
Google Scholar
Fleming GF, Ma CX, Huo D, Sattar H, Tretiakova M, Lin L, Hahn OM, Olopade FO, Nanda R, Hoffman PC, et al. Phase II trial of temsirolimus in patients with metastatic breast cancer. Breast Cancer Res Treat. 2012;136(2):355–63.
Article
CAS
PubMed
PubMed Central
Google Scholar
Hortobagyi GN, Chen D, Piccart M, Rugo HS, Burris HA 3rd, Pritchard KI, Campone M, Noguchi S, Perez AT, Deleu I, et al. Correlative Analysis of Genetic Alterations and Everolimus Benefit in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Results From BOLERO-2. J Clin Oncol. 2016;34(5):419–26.
Article
CAS
PubMed
Google Scholar
Krop IE, Mayer IA, Ganju V, Dickler M, Johnston S, Morales S, Yardley DA, Melichar B, Forero-Torres A, Lee SC, et al. Pictilisib for oestrogen receptor-positive, aromatase inhibitor-resistant, advanced or metastatic breast cancer (FERGI): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol. 2016;17(6):811–21.
Article
CAS
PubMed
PubMed Central
Google Scholar
Mayer IA, Abramson VG, Isakoff SJ, Forero A, Balko JM, Kuba MG, Sanders ME, Yap JT, Van den Abbeele AD, Li Y, et al. Stand up to cancer phase Ib study of pan-phosphoinositide-3-kinase inhibitor buparlisib with letrozole in estrogen receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol. 2014;32(12):1202–9.
Article
CAS
PubMed
PubMed Central
Google Scholar
Mayer IA, Abramson VG, Formisano L, Balko JM, Estrada MV, Sanders ME, Juric D, Solit D, Berger MF, Won HH, et al. A Phase Ib Study of Alpelisib (BYL719), a PI3Kalpha-Specific Inhibitor, with Letrozole in ER+/HER2- Metastatic Breast Cancer. Clin Cancer Res. 2017;23(1):26–34.
Article
CAS
PubMed
Google Scholar
Moynahan ME, Chen D, He W, Sung P, Samoila A, You D, Bhatt T, Patel P, Ringeisen F, Hortobagyi GN, et al. Correlation between PIK3CA mutations in cell-free DNA and everolimus efficacy in HR(+), HER2(-) advanced breast cancer: results from BOLERO-2. Br J Cancer. 2017;116(6):726–30.
Article
CAS
PubMed
PubMed Central
Google Scholar
Mosele F, Verret B, Lusque A, Filleron T, Bachelot T, Arnedos M, Campone M, Dalenc F, Lefeuvre C, Sablin MP, et al. Abstract 4895: Natural history and outcome of patients presenting a metastatic breast cancer with PIK3CA mutation. Cancer Res. 2019;79(Suppl 13):4895.
Article
Google Scholar
Tolaney SM, et al. Clinical Significance of PIK3CA and ESR1 Mutations in Circulating Tumor DNA: Analysis from the MONARCH 2 Study of Abemaciclib plus Fulvestrant. Clin Cancer Res. 2022;28(8):1500–6.
Article
CAS
PubMed
Google Scholar
Guyot P, et al. Enhanced secondary analysis of survival data: reconstructing the data from published Kaplan-Meier survival curves. BMC Med Res Methodol. 2012;12:9.
Article
PubMed
PubMed Central
Google Scholar
Latimer NR. Survival Analysis for Economic Evaluations Alongside Clinical Trials—Extrapolation with Patient-Level Data:Inconsistencies, Limitations, and a Practical Guide. Med Decis Making. 2013;33(6):743–54.
Article
PubMed
Google Scholar
Wan X, et al. Estimating the sample mean and standard deviation from the sample size, median, range and/or interquartile range. BMC Med Res Methodol. 2014;14(1):1–13.
Article
Google Scholar
DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials. 1986;7(3):177–88.
Article
CAS
PubMed
Google Scholar
Nakagawa S, Santos ES. Methodological issues and advances in biological meta-analysis. Evol Ecol. 2012;26(5):1253–74.
Article
Google Scholar
Cohen J. Statistical power analysis for the social sciences. 1988.
Google Scholar
Higgins JP, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA, editors. Cochrane handbook for systematic reviews of interventions. Wiley; 2019.
André F, Ciruelos EM, Rubovszky G, Campone M, Loibl S, Rugo HS, Iwata H, Conte P, Mayer IA, Kaufman B, Yamashita T. Alpelisib (ALP)+ fulvestrant (FUL) for advanced breast cancer (ABC): results of the phase III SOLAR-1 trial. Annals of Oncology. 2018;29:viii709.
Berkowitz N, Gupta S, Silberman G. Estimates of the lifetime direct costs of treatment for metastatic breast cancer. Value in Health. 2000;3(1):23–30.
Article
CAS
PubMed
Google Scholar
Yin W, et al. Association between breast cancer disease progression and workplace productivity in the United States. J Occup Environ Med. 2017;59(2):198–204.
Article
PubMed
Google Scholar
Zardavas D, et al. Tumor PIK3CA Genotype and Prognosis in Early-Stage Breast Cancer: A Pooled Analysis of Individual Patient Data. J Clin Oncol. 2018;36(10):981–90.
Article
CAS
PubMed
Google Scholar
Elfgen C, et al. Prognostic impact of PIK3CA protein expression in triple negative breast cancer and its subtypes. J Cancer Res Clin Oncol. 2019;145(8):2051–9.
Article
CAS
PubMed
Google Scholar
Sobhani N, et al. The prognostic value of PI3K mutational status in breast cancer: A meta-analysis. J Cell Biochem. 2018;119(6):4287–92.
Article
CAS
PubMed
PubMed Central
Google Scholar
Mosele F, et al. Outcome and molecular landscape of patients with PIK3CA-mutated metastatic breast cancer. Ann Oncol. 2020;31(3):377–86.
Article
CAS
PubMed
Google Scholar
Chandarlapaty S, et al. Prevalence of ESR1 mutations in cell-free DNA and outcomes in metastatic breast cancer: a secondary analysis of the BOLERO-2 clinical trial. JAMA Oncol. 2016;2(10):1310–5.
Article
PubMed
PubMed Central
Google Scholar
Rosenberg S, et al. Survival Implications of the Relationship between Tissue versus Circulating Tumor DNA TP53 Mutations—A Perspective from a Real-World Precision Medicine Cohort. Mol Cancer Ther. 2020;19(12):2612–20.
Article
CAS
PubMed
Google Scholar
De Mattos-Arruda L, Caldas C. Cell-free circulating tumour DNA as a liquid biopsy in breast cancer. Mol Oncol. 2016;10(3):464–74.
Article
PubMed
CAS
Google Scholar
Li H, et al. Plasma PIK3CA ctDNA specific mutation detected by next generation sequencing is associated with clinical outcome in advanced breast cancer. Am J Cancer Res. 2018;8(9):1873.
CAS
PubMed
PubMed Central
Google Scholar
Filipenko M, et al. Association between the prevalence of somatic mutations in PIK3CA gene in tumors and clinical and morphological characteristics of breast cancer patients. Bull Exp Biol Med. 2017;163(2):250–4.
Article
CAS
PubMed
Google Scholar