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Key Ongoing Clinical Trials in HR-Positive/HER2-Negative Early-Stage Breast Cancer
  • CME
  • CE

Denise A. Yardley, MD
Released: September 22, 2022
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References

  1. Loibl S, Furlanetto J. Integrating CDK4/6 inhibitors in the treatment of patients with early breast cancer. Breast. 2022;62(suppl 1):S70-S79.
  2. Otto T, Sicinski P. Cell cycle proteins as promising targets in cancer therapy. Nat Rev Cancer. 2017;17:93-115.
  3. Corona SP, Generali D. Abemaciclib: a CDK4/6 inhibitor for the treatment of HR+/HER2- advanced breast cancer. Drug Des Devel Ther. 2018;12:321-330.
  4. Tripathy D, Bardia A, Sellers WR. Ribociclib (LEE011): mechanism of action and clinical impact of this selective cyclin-dependent kinase 4/6 inhibitor in various solid tumors. Clin Cancer Res. 2017;23:3251-3262.
  5. Palbociclib [prescribing information]. Groton, CT: Pfizer Inc.; 2019.
  6. Ribociclib [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp.; 2022.
  7. Abemaciclib [prescribing information]. Indianapolis, IN: Eli Lilly and Co.; 2021.
  8. Pedersen RN, Esen BÖ, Mellemkjær L, et al. The incidence of breast cancer recurrence 10-32 years after primary diagnosis. J Natl Cancer Inst. 2022;114:391-399.
  9. Johnston SRD, Harbeck N, Hegg R, et al. Abemaciclib combined with endocrine therapy for the adjuvant treatment of HR+, HER2-, node-positive, high-risk, early breast cancer (monarchE). J Clin Oncol. 2020;38:3987-3998.
  10. Harbeck N, Rastogi P, Martin M, et al. Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: updated efficacy and Ki-67 analysis from the monarchE study. Ann Oncol. 2021;32:1571-1581.
  11. Slamon DJ, Fasching PA, Patel R, et al. NATALEE: phase III study of ribociclib (RIBO) + endocrine therapy (ET) as adjuvant treatment in hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2–) early breast cancer (EBC). Presented at: 2019 American Society of Clinical Oncology Annual Meeting; May 31 - June 4, 2019. Abstract TPS597.
  12. Gluz O, Scheffen I, Degenhardt T, et al. ADAPTlate: a randomized, controlled, open-label, phase III trial on adjuvant dynamic marker—adjusted personalized therapy comparing abemaciclib combined with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy in (clinical or genomic) high-risk, HR+/HER2- early breast cancer. Presented at: 2021 American Society of Clinical Oncology Annual Meeting; June 4-8, 2021. Abstract TPS598.
  13. Spring LM, Gupta A, Reynolds KL, et al. Neoadjuvant endocrine therapy for estrogen receptor-positive breast cancer: a systematic review and meta-analysis. JAMA Oncol. 2016;2:1477-1486.
  14. Tolaney SM, Fallowfield L, Kaufman PA, et al. eMonarcHER: a phase 3 study of abemaciclib plus standard adjuvant endocrine therapy in patients with HR+, HER2+, node-positive, high-risk early breast cancer. Presented at: 2021 American Society of Clinical Oncology Annual Meeting; June 4-8, 2021. Abstract TPS596.
  15. Hurvitz SA, Martin M, Press MF, et al. Potent cell-cycle inhibition and upregulation of immune response with abemaciclib and anastrozole in neoMONARCH, phase II neoadjuvant study in HR+/HER2− breast cancer. Clin Cancer Res. 2020;26:566-580.
  16. Jeselsohn R, Yelensky R, Buchwalter G, et al. Emergence of constitutively active estrogen receptor-α mutations in pretreated advanced estrogen receptor-positive breast cancer. Clin Cancer Res. 2014;20:1757-1767.
  17. Bardia A, Kabos P, Elledge R, et al. Evaluation of RAD1901, a novel investigational, selective estrogen receptor degrader (SERD), for the treatment of ER-positive (ER+) advanced breast cancer. Presented at: 2017 American Society of Clinical Oncology Annual Meeting; June 2-6, 2017. Abstract 1014.
  18. 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;34:2961-2968.
  19. Fulvestrant [prescribing information]. Cambridge, United Kingdom: AstraZeneca; 2021.
  20. Zhang C, Guo S, Yang L, et al. Metabolism, pharmacokinetics, and bioavailability of ZB716, a steroidal selective estrogen receptor downregulator (SERD). Oncotarget. 2017;8:103874-103889.
  21. Jhaveri K, Juric D, Yap Y-S, et al. A phase i study of LSZ102, an oral selective estrogen receptor degrader, with or without ribociclib or alpelisib, in patients with estrogen receptor–positive breast cancer. Clin Cancer Res. 2021;27:5760-5770.
  22. Dees EC, Aftimos PG, Menke-van der Houven van Oordt CW, et al. Dose-escalation study of G1T48, an oral selective estrogen receptor degrader (SERD), in postmenopausal women with ER+/HER2- locally advanced or metastatic breast cancer (ABC). Presented at: European Society for Medical Oncology Congress 2019; September 27 - October 1, 2019. Abstract 3587.
  23. Maglakelidze M, Bulat I, Ryspayeva D, et al. Rintodestrant (G1T48), an oral selective estrogen receptor degrader, in combination with palbociclib for ER+/HER2– advanced breast cancer: phase 1 results. Presented at: 2021 American Society of Clinical Oncology Annual Meeting; June 4-8, 2021. Abstract 1063.
  24. Campone M, Bardia A, Ulaner GA, et al. Phase 1/2 dose-escalation and expansion study investigating SAR439859, a potent, oral, selective estrogen receptor degrader, +/- palbociclib in metastatic breast cancer. Presented at: 2019 San Antonio Breast Cancer Symposium; December 10-14, 2019. Abstract OT1-04-05.
  25. 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;[Online ahead of print].
  26. Jhaveri K, Winer EP, Perez Fidalgo JA, et al. A first-in-human phase I study to evaluate the oral selective estrogen receptor degrader (SERD), GDC-9545, in postmenopausal women with estrogen receptor-positive (ER+) HER2-negative (HER2-) metastatic breast cancer. Presented at: 2019 San Antonio Breast Cancer Symposium; December 10-14, 2019. Abstract PD7-05.
  27. Hamilton EP, Oliveira M, Banerji U, et al. A phase I dose escalation and expansion study of the next generation oral SERD AZD9833 in women with ER-positive, HER2-negative advanced breast cancer. Presented at: 2020 American Society of Clinical Oncology Annual Meeting; May 29-31, 2020. Abstract 1024.
  28. Lim E, Jhaveri KL, Alejandro Perez-Fidalgo J, et al. A phase Ib study to evaluate the oral selective estrogen receptor degrader GDC-9545 alone or combined with palbociclib in metastatic ER-positive HER2-negative breast cancer. Presented at: 2020 American Society of Clinical Oncology Annual Meeting; May 29-31, 2020. Abstract 1023.
  29. Rinnerthaler G, Gampenrieder SP, Greil R. HER2 directed antibody-drug-conjugates beyond T-DM1 in breast cancer. Int J Mol Sci. 2019;20:1115.
  30. Nakada T, Sugihara K, Jikoh T, et al. the latest research and development into the antibody-drug conjugate, [fam-] trastuzumab deruxtecan (DS-8201a), for HER2 cancer therapy. Chem Pharm Bull (Tokyo). 2019;67:173-185.
  31. Ogitani Y, Hagihara K, Oitate M, et al. Bystander killing effect of DS-8201a, a novel anti-human epidermal growth factor receptor 2 antibody-drug conjugate, in tumors with human epidermal growth factor receptor 2 heterogeneity. Cancer Sci. 2016;107:1039-1046.
  32. Trastuzumab deruxtecan [prescribing information]. Basking Ridge, NJ: Daiichi Sankyo, Inc.; 2022.
  33. Modi S, Jacot W, Yamashita T, et al. Trastuzumab deruxtecan in previously treated HER2-low advanced breast cancer. N Engl J Med. 2022;387:9-20.
  34. Hurvitz SA, Peddi PF, Tetef ML, et al. TRIO-US B-12 TALENT: phase II neoadjuvant trial evaluating trastuzumab deruxtecan with or without anastrozole for HER2-low, HR+ early stage breast cancer. Presented at: 2021 American Society of Clinical Oncology Annual Meeting; June 4-8, 2021. Abstract TPS603.
  35. Sacituzumab govitecan-hziy [prescribing information]. Morris Plains, NJ: Immunomedics, Inc.; 2022.
  36. Hirshfield K, Cardoso F, Bardia A, et al. KEYNOTE-756: A randomized, double-blind, phase 3 study of pembrolizumab or placebo with neoadjuvant chemotherapy and adjuvant endocrine therapy for high-risk, early-stage, ER+/HER2− breast cancer. Presented at: ASBS; April 30 - May 5, 2020. Abstract 785859.
  37. Loi S, McArthur HL, Harbeck N, et al. A phase III trial of nivolumab with neoadjuvant chemotherapy and adjuvant endocrine therapy in ER+/HER2- primary breast cancer: CheckMate 7FL. Presented at: 2020 American Society of Clinical Oncology Annual Meeting; May 29-31, 2020. Abstract TPS604.
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