HR-Positive HER2-Negative BC

CE / CME

Improving Outcomes in Patients With High-Risk Breast Cancer: Expert Guidance and Team Training for HR-Positive/HER2-Negative Disease

Physician Assistants/Physician Associates: 1.00 AAPA Category 1 CME credit

Nurses: 1.00 Nursing contact hour

Physicians: maximum of 1.00 AMA PRA Category 1 Credit

Pharmacists: 1.00 contact hour (0.1 CEUs)

Released: March 22, 2024

Expiration: March 21, 2025

Joyce O'Shaughnessy
Joyce O'Shaughnessy, MD

Activity

Progress
1 2
Course Completed

References

  1. National Comprehensive Cancer Network. Clinical practice guidelines in oncology: breast cancer. v.1.2024. nccn.org.
  2. Johnston SRD, Toi M, O’Shaughnessy J, et al. Abemaciclib plus endocrine therapy for hormone receptor-positive, HER2-negative, node-positive, high-risk early breast cancer (monarchE): results from a preplanned interim analysis of a randomised, open-label, phase 3 trial. Lancet Oncol. 2023;24:77-90.
  3. Geyer CE Garber JE, Gelber RD, et al. Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high-risk, early breast cancer. Ann Oncol. 2022;33:1250-1268.
  4. Mayer EL. Dueck AC, Martin M, et al. Palbociclib with adjuvant endocrine therapy in early breast cancer (PALLAS): interim analysis of a multicentre, open-label, randomised, phase 3 study. Lancet Oncol. 2021;22:212-222.
  5. Loibl S, Marme F, Martin M, et al. Palbociclib for residual high-risk invasive HR-positive and HER2-negative early breast cancer-the Penelope-B trial. J Clin Oncol. 2021;39:1518-1530.
  6. Slamon DJ, Fasching PA, Ravindranath P, et al. NATALEE: phase III study of ribociclib (ribo) + endocrine therapy (ET) as adjuvant treatment in hormone receptor-positive (HR+), huma epidermal growth factor receptor 2-negative (HER2-) early breast cancer (EBC). Presented at: 2019 American Society of Clinical Oncology Annual Meeting; June 2-6, 2019. Abstract TPS597.
  7. Harbeck N, Rastogi P, O’Shaughnessy J, et al. Adjuvant abemaciclib plus endocrine therapy for HR+, HER2-, high-risk early breast cancer: results from a preplanned monarchE overall survival interim analysis, including 5-year efficacy Outcomes. Presented at: European Society for Medical Oncology Congress 2023; October 20-24, 2023. Abstract LBA17.
  8. Abemaciclib [prescribing information]. Indianapolis, IN: Lilly USA, LLC; 2023.
  9. Giordano SH, Freedman RA, Somerfield MR, et al. Abemaciclib with endocrine therapy in the treatment of high-risk early breast cancer: ASCO optimal adjuvant chemotherapy and targeted therapy guideline rapid recommendation update. J Clin Oncol. 2022;40:307-309.
  10. Hortobagyi GN, Stroyakovsky D, Yardle D, et al. Ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) as adjuvant treatment in patients with HR+/HER2- early breast cancer: final invasive disease-free survival (iDFS) analysis from the NATALEE trial. Presented at: 2023 San Antonio Breast Cancer Symposium; December 5-9, 2023. Abstract GS03-03.
  11. Geyer CE, Garber JE, Gelber RD, et al. Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high-risk, early breast cancer. Ann Oncol. 2022;33:1250-1268.
  12. Sparano JA, Gray RJ, Makower DF, et al. Adjuvant chemotherapy guided by a 21-gene expression assay in breast cancer. N Engl J Med. 2018;379:111-121.
  13. Kalinsky K, Barlow WE, Gralow JR, et al. 21-gene assay to inform chemotherapy benefit in node-positive breast cancer. N Engl J Med. 2021;385:2336-2347.
  14. Cardoso F, van’t Veer LJ, Bogaerts J, et al. 70-gene signature as an aid to treatment decisions in early-stage breast cancer. N Engl J Med. 2016;375:717-729.
  15. Tung NM, Robson ME, Ventz S, et al. TBCRC 048: phase II study of olaparib for metastatic breast cancer and mutations in homologous recombination-related genes. J Clin Oncol. 2020;38:4274-42-82.
  16. Rugo HS, Finn RS, Dieras V, et al. Palbociclib plus letrozole as first-line therapy in estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer with extended follow-up. Breast Cancer Res Treat. 2019;174:719-729.
  17. Finn RS, Rugo HS, Dieras VC, et al. Overall survival (OS) with first-line palbociclib plus letrozole (PBO+LET) in women with estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer (ER+/HER2- ABC): analyses from PALOMA-2. Presented at: 2022 American Society of Clinical Oncology Annual Meeting; June 3-7, 2022. Abstract LBA1003.
  18. 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;1541-1547.
  19. Hortobagyi GN, Stemmer SM, Burris HA, et al. Overall survival with ribociclib plus letrozole in advanced breast cancer. N Engl J Med. 2022;386;942-950.
  20. Tripathy D, Im S-A, 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;904-915.
  21. Im S-A, Lu Y-S, Bardia A, et al. Overall survival with ribociclib plus endocrine therapy in breast cancer. N Engl J Med. 2019;381;307-316.
  22. Lu YS, Bin Mohd Mahidin EI, Azim H, et al. Primary results from the randomized phase II RIGHT Choice trial of premenopausal patients with aggressive hormone receptor-positive HER2-negative advanced breast cancer treated with ribociclib + endocrine therapy vs physician’s choice combination chemotherapy. Presented at: 2022 San Antonio Breast Cancer Symposium; December 6-10, 2022. Abstract GS1-10.
  23. Goetz MP, Toi M, Huober J, et al. MONARCH 3: interim overall survival (OS) results of abemaciclib plus a nonsteroidal aromatase inhibitor (NSAI) in patients (pts) with HR+, HER2- advanced breast cancer (ABC). Presented at: European Society for Medical Oncology Congress 2022; September 9-13, 2022. Abstract LBA15.
  24. 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. 2018;36:2465-2472.
  25. 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;32:1015-1024.
  26. Lu YS, EI BM, Azim H, et al. Primary results from the randomized RIGHT Choice trial of premenopausal patients with aggressive HR+/HER2- advanced breast cancer treated with ribociclib + endocrine therapy vs physician’s choice combination chemotherapy. Presented at: 2022 San Antonio Breast Cancer Symposium; December 6-10, 2022. Abstract GS1-10.
  27. Goetz MP, Toi M, Huober J, et al. MONARCH 3: final overall survival results of abemaciclib plus a nonsteroidal aromatase inhibitor as first-line therapy in patients with HR+, HER2- advanced breast cancer. Presented at: 2023 San Antonio Breast Cancer Symposium; December 5-9, 2023. Abstract LBA GS01-12.
  28. Kalinsky K, Layman RM, Kaufman PA, et al. PostMONARCH: a phase 3 study of abemaciclib plus fulvestrant versus placebo plus fulvestrant in patients with HR+, HER2-, metastatic breast cancer following progression on a CDK4 & 6 inhibitor and endocrine therapy. Presented at: 2022 American Society of Clinical Oncology Annual Meeting; June 3-7, 2022. Abstract TPS1117.
  29. André F, Ciruelos E, Rubovszky G, et al; SOLAR-1 Study Group. Alpelisib for PIK3CA-mutated, hormone receptor-positive advanced breast cancer. N Engl J Med. 2019;380:1929-1940.
  30. André F, Ciruelos EM, Juric D, 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;32:208-217.
  31. Anderson EJ, Mollon LE, Dean JL, et al. A systematic review of the prevalence and diagnostic workup of PIK3CA mutations in HR+/HER2- metastatic breast cancer. Int J Breast Cancer. 2020;2020:3759179.
  32. Alpelisib [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2022.
  33. Rugo HS, Lerebours F, Ciruelos E, et al. Alpelisib plus fulvestrant in PIK3CA-mutated, hormone receptor-positive advanced breast cancer after a CDK4/6 inhibitor (BYLieve): one cohort of a phase 2, multicentre, open-label, non-comparative study. Lancet Oncol. 2021;22:489-498.
  34. Chia S. Neven P, Ciruelos EM, et al. Alpelisib + endocrine therapy in patients with PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative, advanced breast cancer: analysis of all 3 cohorts of the BYLieve study. J Clin Oncol. 2023;41(suppl 16):Abstract 1078.
  35. Capivasertib [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals, LP; 2023.
  36. Turner NC, Oliveira M, Howell SJ, et al; CAPItello-291 Study Group. Capivasertib in hormone receptor-positive advanced breast cancer. N Engl J Med. 2023;388:2058-2070.
  37. Allouchery V, Beaussire L, Perdrix A, et al. Circulating ESR1 mutations at the end of aromatase inhibitor adjuvant treatment and after relapse in breast cancer patients. Breast Cancer Res. 2018;20:40.
  38. Bidard FC, Kaklamani VG, Neven P, et al. Elacestrant (oral selective estrogen receptor degrader) versus standard endocrine therapy for estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: results from the randomized phase III EMERALD trial. J Clin Oncol. 2022;40:3246-3256.
  39. Bardia A, Bidard FC, Neven P, et al. EMERALD phase 3 trial of elacestrant versus standard of care endocrine therapy in patients with ER+/HER2- metastatic breast cancer: updated results by duration of prior CDK4/6i in metastatic setting. Presented at: 2022 San Antonio Breast Cancer Symposium; December 6-10, 2022. Abstract GS3-01.
  40. Mittal A, Molto Valiente C, Tamimi F, et al. Filling the gap after CDK4/6 inhibitors: novel endocrine and biologic treatment options for metastatic hormone receptor positive breast cancer. Cancers (Basel). 2023;15:2015.
  41. Elacestrant [prescribing information]. New York, NY: Stemline Therapeutics, Inc; 2023.
  42. Oliveira M, Pominchuck D, Nowecki Z, et al. Camizestrant, a next generation oral SERD vs fulvestrant in post-menopausal women with advanced ER-positive HER2-negative breast cancer: results of the randomized, multi-dose phase 2 SERENA-2 trial. Presented at: 2022 San Antonio Breast Cancer Symposium; December 6-10, 2022. Abstract GS3-02.
  43. Jhaveri KL, Wang HC, Ma CX, et al. Imlunestrant, an oral selective estrogen receptor degrader, in combination with abemaciclib with or without an aromatase inhibitor, in estrogen receptor-positive advanced breast cancer: results from the phase 1a/b EMBER study. Presented at: 2022 San Antonio Breast Cancer Symposium; December 6-10, 2022. Abstract PD13-12.
  44. Rugo HS, Bardia A, Marmé F, et al. Overall survival with sacituzumab govitecan in hormone receptor-positive and human epidermal growth factor receptor 2-negative metastatic breast cancer (TROPiCS-02): a randomized, open-label, multicentre, phase 3 trial. Lancet. 2023;402:1423-1433.
  45. Tolaney SM, Bardia A, Marmé F, et al. Final overall survival (OS) analysis from the phase 3 TROPiCS-02 study of sacituzumab govitecan (SG) in patients (pts) with hormone receptor-positive/HER2-negative (HR+/HER2-) metastatic breast cancer (mBC). Presented at: 2023 American Society of Clinical Oncology Annual Meeting; June 2-6, 2023. Abstract 1003.
  46. Fam-trastuzumab deruxtecan-nxki [prescribing information]. Basking Ridge, NJ and Wilmington, DE: Daiichi Sankyo, Inc and AstraZeneca Pharmaceuticals, LP; 2024.
  47. Modi S, Jacot W, Yamashita T, et al; DESTINY-Breast04 Trial Investigators. Trastuzumab deruxtecan in previously treated HER2-low advanced breast cancer. N Engl J Med. 2022;387:9-20.
  48. Kalinsky K, Accordino MK, Chiuzan C, et al. 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. J Clin Oncol. 2023;41:4004-4013.
  49. Jhaveri KL, Goldman JW, Hurvitz SA, et al. Neratinib plus fulvestrant plus trastuzumab (N+F+T) for hormone receptor-positive (HR+), HER2-negative, HER2-mutant metastatic breast cancer (MBC): outcomes and biomarker analysis from the SUMMIT trial. J Clin Oncol. 2022;40(suppl 16):Abstract 1028.
  50. Palbociclib [prescribing information]. New York, NY: Pfizer Inc; 2022.
  51. Ribociclib [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2022.
  52. Rugo HS, O’Shaughnessy J, Boyle F, et al. Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: safety and patient-reported outcomes from the monarchE study. Ann Oncol. 2022;33:616-627.
  53. Sammons S, Moore H, Cushman, et al. Efficacy, safety, and toxicity management of adjuvant abemaciclib in early-stage HR+/HER2- high-risk breast cancer. Exp Rev Anticancer Ther. 2022;22:805-814.