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REVIEW

Evaluating Elacestrant in the Management of ER-Positive, HER2-Negative Advanced Breast Cancer: Evidence to Date

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Pages 189-196 | Received 07 Dec 2022, Accepted 15 Mar 2023, Published online: 23 Mar 2023

References

  • Giaquinto AN, Sung H, Miller KD, et al. Breast cancer statistics, 2022. CA Cancer J Clin. 2022. doi:10.3322/caac.21754
  • Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022;72(1):7–33. doi:10.3322/caac.21708
  • Hwang KT, Kim J, Jung J, et al. Impact of breast cancer subtypes on prognosis of women with operable invasive breast cancer: a population-based study using SEER database. Clin Cancer Res. 2019;25(6):1970–1979. doi:10.1158/1078-0432.CCR-18-2782
  • Pan H, Gray R, Braybrooke J; for EBCTCG. 20-year risks of breast-cancer recurrence after stopping endocrine therapy at 5 years. N Engl J Med. 2017;377(19):1836–1846. doi:10.1056/NEJMoa1701830
  • Burstein HJ, Somerfield MR, Barton DL, et al. Endocrine treatment and targeted therapy for hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer: ASCO guideline update. J Clin Oncol. 2021;39(35):3959–3977. doi:10.1200/JCO.21.01392
  • Cardoso F, Paluch-Shimon S, Senkus E, et al. 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5). Ann Oncol. 2020;31(12):1623–1649. doi:10.1016/j.annonc.2020.09.010
  • Howell A, Pippen J, Elledge RM, et al. Fulvestrant versus anastrozole for the treatment of advanced breast carcinoma: a prospectively planned combined survival analysis of two multicenter trials. Cancer. 2005;104(2):236–239. doi:10.1002/cncr.21163
  • Di Leo A, Jerusalem G, Petruzelka L, et al. Final overall survival: fulvestrant 500 mg vs 250 mg in the randomized CONFIRM trial. J Natl Cancer Inst. 2014;106(1):djt337. doi:10.1093/jnci/djt337
  • Cristofanilli M, Turner NC, Bondarenko I, 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):425–439. doi:10.1016/S1470-2045(15)00613-0
  • Slamon DJ, Neven P, Chia S, 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(24):2465–2472. doi:10.1200/JCO.2018.78.9909
  • Sledge GW, Toi M, Neven P, 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(1):116–124. doi:10.1001/jamaoncol.2019.4782
  • André F, Ciruelos E, Rubovszky G, et al.; for SOLAR-1 Study Group. Alpelisib for PIK3CA-mutated, hormone receptor-positive advanced breast cancer. N Engl J Med. 2019;380(20):1929–1940. doi:10.1056/NEJMoa1813904
  • Jeselsohn R, Buchwalter G, De Angelis C, Brown M, Schiff R. ESR1 mutations—a mechanism for acquired endocrine resistance in breast cancer. Nat Rev Clin Oncol. 2015;12(10):573–583. doi:10.1038/nrclinonc.2015.117
  • van Kruchten M, de Vries EG, Glaudemans AW, et al. Measuring residual estrogen receptor availability during fulvestrant therapy in patients with metastatic breast cancer. Cancer Discov. 2015;5(1):72–81. doi:10.1158/2159-8290.CD-14-0697
  • Garner F, Shomali M, Paquin D, Lyttle CR, Hattersley G. RAD1901: a novel, orally bioavailable selective estrogen receptor degrader that demonstrates antitumor activity in breast cancer xenograft models. Anticancer Drugs. 2015;26(9):948–956. doi:10.1097/CAD.0000000000000271
  • Wardell SE, Nelson ER, Chao CA, Alley HM, McDonnell DP. Evaluation of the pharmacological activities of RAD1901, a selective estrogen receptor degrader. Endocr Relat Cancer. 2015;22(5):713–724. doi:10.1530/ERC-15-0287
  • Bihani T, Patel HK, Arlt H, et al. Elacestrant (RAD1901), a selective estrogen receptor degrader (SERD), has antitumor activity in multiple ER+ breast cancer patient-derived xenograft models. Clin Cancer Res. 2017;23(16):4793–4804. doi:10.1158/1078-0432.CCR-16-2561
  • Patel HK, Tao N, Lee KM, et al. Elacestrant (RAD1901) exhibits anti-tumor activity in multiple ER+ breast cancer models resistant to CDK4/6 inhibitors. Breast Cancer Res. 2019;21(1):146. doi:10.1186/s13058-019-1230-0
  • Jager A, de Vries EGE, der Houven van Oordt CWM, et al. A phase 1b study evaluating the effect of elacestrant treatment on estrogen receptor availability and estradiol binding to the estrogen receptor in metastatic breast cancer lesions using 18F-FES PET/CT imaging. Breast Cancer Res. 2020;22(1):97. doi:10.1186/s13058-020-01333-3
  • Bardia A, Kaklamani V, Wilks S, et al. Phase I study of elacestrant (RAD1901), a novel selective estrogen receptor degrader, in ER-positive, HER2-negative advanced breast cancer. J Clin Oncol. 2021;39(12):1360–1370. doi:10.1200/JCO.20.02272
  • 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(28):3246–3256. doi:10.1200/JCO.22.00338
  • 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 SABCS 2022; Abstract GS3-01. December 6-10, 2022.
  • Elacestrant in preoperative setting, a window of opportunity study (ELIPSE). Clinical Trial Identifier NCT04797728. Available from: https://clinicaltrials.gov/ct2/show/NCT04797728. Accessed November 24, 2022.
  • Elacestrant for treating ER+/HER2- breast cancer patients with ctDNA relapse (EORTC-2129-BCG). Clinical Trial Identifier NCT05512364. Available from: https://clinicaltrials.gov/ct2/show/NCT05512364. Accessed November 24, 2022.
  • An open-label multicenter phase 1b-2 study of elacestrant as monotherapy and in combination with abemaciclib in women and men with brain metastasis from estrogen receptor positive, HER-2 negative breast cancer (ELECTRA). Clinical Trial Identifier NCT05386108. Available from: https://clinicaltrials.gov/ct2/show/NCT05386108. Accessed November 24, 2022.
  • A phase 1b/2, open-label umbrella study to evaluate safety and efficacy of elacestrant in various combination in patients with metastatic breast cancer (ELEVATE). Clinical Trial Identifier NCT05563220. Available from: https://clinicaltrials.gov/ct2/show/NCT05563220. Accessed November 24, 2022.
  • Multicenter open label phase Ib/II trial of abemaciclib and elacestrant in patients with brain metastasis due to HR+/Her2- breast cancer. Clinical Trial Identifier NCT04791384. Available from: https://clinicaltrials.gov/ct2/show/NCT04791384. Accessed November 24, 2022.
  • Lloyd MR, Wander SA, Hamilton E, Razavi P, Bardia A. Next-generation selective estrogen receptor degraders and other novel endocrine therapies for management of metastatic hormone receptor-positive breast cancer: current and emerging role. Ther Adv Med Oncol. 2022;14:17588359221113694. doi:10.1177/17588359221113694
  • Bardia A, Chandarlapaty S, Linden HM, et al. AMEERA-1 phase 1/2 study of amcenestrant, SAR439859, in postmenopausal women with ER-positive/HER2-negative advanced breast cancer. Nat Commun. 2022;13(1):4116. doi:10.1038/s41467-022-31668-8
  • Tolaney SM, Chan A, Petrakova K, et al. AMEERA-3, a phase II study of amcenestrant (AMC) versus endocrine treatment of physician’s choice (TPC) in patients (pts) with endocrine-resistant ER+/HER2− advanced breast cancer (aBC). Ann Oncol. 2022;33(suppl_7):S88–S121. doi:10.1016/annonc/annonc1040
  • Martin Jimenez M, Lim E, Chavez-Mac Gregor M, et al. Giredestrant (GDC-9545) vs physician choice of endocrine monotherapy (PCET) in patients (pts) with ER+, HER2– locally advanced/metastatic breast cancer (LA/mBC): primary analysis of the Phase II, randomised, open-label acelERA BC study. Ann Oncol. 2022;33(suppl_7):S88–S121. doi:10.1016/annonc/annonc1040
  • Jhaveri K, Lim E, Hamilton E, et al. A first-in-human phase 1a/b trial of LY3484356, an oral selective estrogen receptor (ER) degrader (SERD) in ER+ advanced breast cancer (aBC) and endometrial endometrioid cancer (EEC): results from the EMBER study. J Clin Oncol. 2021;39(15_suppl):1050. doi:10.1200/JCO.2021.39.15_suppl.1050
  • 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. J Clin Oncol. 2021;39(15_suppl):1063. doi:10.1200/JCO.2021.39.15_suppl.1063
  • Hamilton E, 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. J Clin Oncol. 2020;38(15_suppl):1024. doi:10.1200/JCO.2020.38.15_suppl.1024
  • Oliveira M, Pominchuk 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. 2022 San Antonio Breast Cancer Symposium; December 6-10, 2022; San Antonio, Texas; abstract GS3-02. Accessed December 8, 2022.