Medical Imaging to Re-evaluate Elacestrant Clinical Usage

NCT07753954 | Not Yet Recruiting Phase 2 FDA Drug

• 2 other identifiers: IJB-IRENA-20252025-524380-20
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to evaluate whether elacestrant, an oral selective oestrogen receptor degrader, can improve outcomes in patients with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer without detectable ESR1 mutation after progression on endocrine therapy plus a CDK4/6 inhibitor. The study aims to answer two key questions:

• Does \[18F\]-fluor-oestradiol positron emission tomography/computed tomography (18F-FES-PET/CT) result (homogeneous vs. heterogeneous) determine the efficacy of elacestrant in participants with advanced/metastatic ER-positive breast cancer and ESR1-mut-nd?
• Does 18F-FES-PET/CT imaging predict patient outcomes, including progression-free survival, overall survival, or tumor response? There is no comparison group in this study. All participants receive elacestrant. Researchers will compare outcomes in people who have different levels of estrogen-receptor heterogeneity on FES-PET/CT imaging. Participants in the study will:
• Take elacestrant 345 mg orally once a day, in 28-day treatment cycles (the dose may be lowered to 258 mg if needed due to side effects).
• Undergo 18F-FES-PET/CT and 18F-FDG-PET/CT imaging both at the beginning of the study and as part of routine clinical evaluation every 8 weeks
• Undergo blood sample collection every 8 weeks
• If selected for a sub-study, undergo an additional FES-PET/CT scan 4 weeks after starting treatment

Conditions

ER+ / HER2- Advanced Breast Cancer

Keywords

Advanced breast cancer; ER+; HER2-; Elacestrant; Imaging

Outcome Measures

Primary Outcomes (1)

• Progression-free survival in participants with ESR1-mut-nd

  To determine the efficacy of elacestrant by 18F-FES-PET/CT result (homogeneous vs. heterogeneous) in participants with advanced/metastatic ER-positive breast cancer and ESR1-mut-nd.

  From first day of treatment until 6 months after first day of treatment

Secondary Outcomes (7)

• Progression-Free Survival (PFS) by central review as per (Response Evaluation Criteria In Solid Tumors) RECIST v1.143/ PET Response Criteria In Solid Tumours (PERCIST)

  From the date of treatment initiation to the date of disease progression or death from any cause, up to the clinical data cut-off (approx. 2 years after the last participant has tarted treatment with elacestrant)

• Objective Response Rate (ORR) by central review, defined as per RECIST v1.143/ PERCIST

  From the date of treatment initiation to the date of disease progression or death from any cause, up to the clinical data cut-off (approx. 2 years after the last participant has tarted treatment with elacestrant)

• Overall Survival (OS), defined as time from the date of treatment start to the date of death from any cause.

  From the date of treatment initiation to the date of disease progression or death from any cause, up to the clinical data cut-off (approx. 2 years after the last participant has tarted treatment with elacestrant)

• PFS and OS rates at 6-month and at 12-month

  From the date of treatment initiation to the date of disease progression or death from any cause, up to the clinical data cut-off (approx. 2 years after the last participant has tarted treatment with elacestrant)

• Time to subsequent chemotherapy, defined as time from the date of start of elacestrant to the date of subsequent chemotherapy start or cancer-related death, whichever comes first.

  From the date of treatment initiation to the date of disease progression or death from any cause, up to the clinical data cut-off (approx. 2 years after the last participant has tarted treatment with elacestrant)

Other Outcomes (1)

• Exploratory objective: PFS in participants treated with elacestrant according to predefined 18F-FES-PET/CT heterogeneity threshold categories.

  From the date of treatment initiation to the date of disease progression or death from any cause, up to the clinical data cut-off (approx. 2 years after the last participant has tarted treatment with elacestrant)

Study Arms (1)

Elacestrant Treatment for ER-Positive, HER2-Negative Breast Cancer Without ESR1 Mutation

EXPERIMENTAL

Drug: Elacestrant

Interventions

Elacestrant DRUG

Elacestrant is an orally available tetrahydronaphthalene compound that acts as selective oestrogen receptor alpha (ERα) antagonist with receptor degrading activity (e.g., selective oestrogen receptor degrader, SERD) and is being developed as a monotherapy agent and in combinations for the treatment of oestrogen receptor (ER) positive breast cancer.

Elacestrant Treatment for ER-Positive, HER2-Negative Breast Cancer Without ESR1 Mutation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• ECOG performance status ≤ 1
• Must have histologically or cytologically confirmed diagnosis of breast cancer with evidence of locally advanced disease not amenable to therapy with curative intent or metastatic disease not amenable to curative therapy.
• Documentation of ER-positive (≥10% positive stained cells) and HER2 negative (0-1+ by immunohistochemistry \[IHC\] or 2+ and negative by in situ hybridization \[ISH\] test) advanced or metastatic breast cancer according to the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines as per local assessment. ER-positive/HER2-negative status should be confirmed in metastatic setting, with exception of patients with bone and lung only disease, where this might not possible.
• Must be appropriate candidates for endocrine monotherapy.
• Must have previously received no more than 1 line of endocrine therapy:
• a) Radiological or objective evidence of disease progression on prior treatment with a CDK4/6 inhibitor in combination with endocrine therapy (either an aromatase inhibitor or fulvestrant) for advanced disease after at least 12 months of treatment.
• b) Patients receiving CDK4/6 inhibitor-based therapy in the adjuvant setting are also eligible provided that disease progression is confirmed after finishing treatment with CDK4/6 inhibitor but no more than 12 months following CDK4/6 inhibitor treatment completion in this scenario, this will count as 1 line of ET for mBC.
• ESR1 mutation not detected, test performed after ET plus CDK4/6 inhibitor. This local determination will be performed in blood using a validated assay.
• No contraindications to perform 18F-FES-PET/CT.
• Life expectancy ≥ 6 months.
• At screening FDG-PET/CT at least two "target" lesions are required to fulfil the following criteria:
• a) anatomically transaxial diameter ≥ 1.5 cm AND
• b) metabolically assessable with a maximum standard uptake value corrected for lean body mass (SUVmax) ≥ 1.5 x SUVmean + 2 standard deviations (SD) of the liver measured in a 3-cm-diameter spherical volume of interest (VOI) in normal liver parenchyma.
• c) In case of suspected liver metastasis, a lesion should have a SUVmax ≥ 2 x SUVmean + 3 SD of the blood pool measured in a 1 cm-diameter VOI within descending thoracic aorta. Lesions pre-treated with irradiation are not eligible for consideration as "target" lesions.

You may not qualify if:

• Prior treatment with elacestrant, or an investigational SERD or ER antagonist.
• Prior chemotherapy for advanced or metastatic disease.
• Prior anti-cancer or investigational drug treatment within the following windows:
• a) Fulvestrant treatment (last injection) \< 5 weeks before first dose of study drug.
• b) Any other endocrine therapy \< 14 days before first dose of study drug.
• c) Chemotherapy or other anti-cancer therapy \< 21 days before first dose of study drug.
• d) Any investigational anti-cancer drug therapy \< 28 days or 5 half-lives (whichever is shorter) before the first dose of study drug.
• Radiation therapy (other than CNS directed) within 14 days before the first dose of study drug. CNS directed radiation therapy within 28 days before the first dose of study drug.
• Active or newly diagnosed CNS metastases, including meningeal carcinomatosis. Note: Patients with stable brain or subdural metastases are allowed if the subject has completed local therapy and was on a stable or decreasing dose of corticosteroids at pre-study treatment period baseline for management of brain metastasis for at least 4 weeks before starting treatment in this study. Any signs (e.g., radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment. If anticonvulsant medication is required, participants must be stable on a non-enzyme inducing anticonvulsant regimen (Appendix 1).
• Participants with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term, including massive uncontrolled effusions (peritoneal, pleural, pericardial), pulmonary lymphangitis, or liver involvement \>50%.
• Intact uterus with a history of endometrial intraepithelial neoplasia (atypical endometrial hyperplasia or higher-grade lesion).
• Diagnosis of any other malignancy within 5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or second primary breast cancer.
• Any of the following within 6 months before enrolment: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE v6.0 Grade ≥2, prolonged QTcF ≥ Grade 2 (i.e., \> 480 msec), uncontrolled atrial fibrillation of any grade, coronary/peripheral artery bypass graft, heart failure ≥ Class II as defined by the New York Heart Association guidelines, or cerebrovascular accident including transient ischemic attack.
• Coagulopathy or any history of coagulopathy within the past 6 months, including history of deep vein thrombosis or pulmonary embolism. However, participants with the following conditions will be allowed to participate:
• a) Adequately treated catheter-related venous thrombosis occurring \> 28 days prior to the first dose of study drug.

Sponsors & Collaborators

• Jules Bordet Institute: lead
• GE Healthcare: collaborator
• Menarini Group: collaborator

Related Publications (39)

• Wahl RL, Jacene H, Kasamon Y, Lodge MA. From RECIST to PERCIST: Evolving Considerations for PET response criteria in solid tumors. J Nucl Med. 2009 May;50 Suppl 1(Suppl 1):122S-50S. doi: 10.2967/jnumed.108.057307.

  PMID: 19403881 BACKGROUND

• Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.

  PMID: 19097774 BACKGROUND

• van Geel JJL, Moustaquim J, Boers J, Elias SG, Smeets EMM, Knip JJ, Glaudemans AWJM, de Vries EFJ, Hospers GAP, van Kruchten M, Stokkel M, Oprea-Lager DE, Menke-van der Houven van Oordt WC, de Vries EGE, Schroder CP; IMPACT-Metastatic Breast Consortium. Intrapatient 16alpha-[18F]Fluoro-17beta-Estradiol PET Heterogeneity as a Prognostic Factor for Endocrine Therapy Response and Survival in Patients with Estrogen Receptor-Positive Metastatic Breast Cancer. J Nucl Med. 2025 Feb 3;66(2):194-200. doi: 10.2967/jnumed.124.268984.

  PMID: 39848768 BACKGROUND

• Cortés J, Bidard FC, Bardia A, et al. 188O EMERALD trial analysis of patient-reported outcomes (PROs) in patients with ER+/HER2- advanced or metastatic breast cancer (mBC) comparing oral elacestrant vs standard of care (SoC) endocrine therapy. ESMO Open. 2023;8(1).

  BACKGROUND

• Pinker K, Riedl CC, Ong L, Jochelson M, Ulaner GA, McArthur H, Dickler M, Gonen M, Weber WA. The Impact That Number of Analyzed Metastatic Breast Cancer Lesions Has on Response Assessment by 18F-FDG PET/CT Using PERCIST. J Nucl Med. 2016 Jul;57(7):1102-4. doi: 10.2967/jnumed.115.166629. Epub 2016 Mar 16.

  PMID: 26985059 BACKGROUND

• Lobo-Martins S, Agostinetto E, de Azambuja E, Gebhart G. Tumour heterogeneity in molecular imaging for breast cancer. Ann Oncol. 2024 Nov;35(11):1061-1062. doi: 10.1016/j.annonc.2024.07.726. Epub 2024 Aug 6. No abstract available.

  PMID: 39098453 BACKGROUND

• Gennari A, Brain E, De Censi A, Nanni O, Wuerstlein R, Frassoldati A, Cortes J, Rossi V, Palleschi M, Alberini JL, Matteucci F, Piccardo A, Sacchetti G, Ilhan H, D'Avanzo F, Ruffilli B, Nardin S, Monti M, Puntoni M, Fontana V, Boni L, Harbeck N; ET-FES Collaborative Group. Early prediction of endocrine responsiveness in ER+/HER2-negative metastatic breast cancer (MBC): pilot study with 18F-fluoroestradiol (18F-FES) CT/PET. Ann Oncol. 2024 Jun;35(6):549-558. doi: 10.1016/j.annonc.2024.02.007. Epub 2024 Feb 28.

  PMID: 38423389 BACKGROUND

• Liu C, Hu S, Xu X, Zhang Y, Wang B, Song S, Yang Z. Evaluation of tumour heterogeneity by 18F-fluoroestradiol PET as a predictive measure in breast cancer patients receiving palbociclib combined with endocrine treatment. Breast Cancer Res. 2022 Aug 26;24(1):57. doi: 10.1186/s13058-022-01555-7.

  PMID: 36028895 BACKGROUND

• Iqbal R, Yaqub M, Bektas HO, Oprea-Lager DE, de Vries EGE, Glaudemans AWJM, Aftimos P, Gebhart G, Beelen AP, Schuit RC, Windhorst AD, Boellaard R, Menke-van der Houven van Oordt CW. [18F]FDG and [18F]FES PET/CT Imaging as a Biomarker for Therapy Effect in Patients with Metastatic ER+ Breast Cancer Undergoing Treatment with Rintodestrant. Clin Cancer Res. 2023 Jun 1;29(11):2075-2084. doi: 10.1158/1078-0432.CCR-22-2720.

  PMID: 36735488 BACKGROUND

• van Kruchten M, de Vries EGE, Brown M, de Vries EFJ, Glaudemans AWJM, Dierckx RAJO, Schroder CP, Hospers GAP. PET imaging of oestrogen receptors in patients with breast cancer. Lancet Oncol. 2013 Oct;14(11):e465-e475. doi: 10.1016/S1470-2045(13)70292-4.

  PMID: 24079874 BACKGROUND

• Liao GJ, Clark AS, Schubert EK, Mankoff DA. 18F-Fluoroestradiol PET: Current Status and Potential Future Clinical Applications. J Nucl Med. 2016 Aug;57(8):1269-75. doi: 10.2967/jnumed.116.175596. Epub 2016 Jun 15.

  PMID: 27307345 BACKGROUND

• Besret L, d'Heilly S, Aubert C, Bluet G, Gruss-Leleu F, Le-Gall F, Caron A, Andrieu L, Vincent S, Shomali M, Bouaboula M, Voland C, Ming J, Roy S, Rao S, Carrez C, Jouannot E. Translational strategy using multiple nuclear imaging biomarkers to evaluate target engagement and early therapeutic efficacy of SAR439859, a novel selective estrogen receptor degrader. EJNMMI Res. 2020 Jun 29;10(1):70. doi: 10.1186/s13550-020-00646-w.

  PMID: 32601772 BACKGROUND

• Groheux D, Vaz SC, Ulaner GA, Cook GJR, Woll JPP, Mann RM, Poortmans P, Cardoso F, Jacene H, Graff SL, Rubio IT, Peeters MV, Dibble EH, de Geus-Oei LF. Joint EANM-SNMMI guidelines on the role of 2-[18F]FDG PET/CT in no special type breast cancer: differences and agreements with European and American guidelines. Eur J Nucl Med Mol Imaging. 2024 Jul;51(9):2701-2705. doi: 10.1007/s00259-024-06694-x. No abstract available.

  PMID: 38693453 BACKGROUND

• Mankoff D, Balogova S, Dunnwald L, Dehdashti F, DeVries E, Evangelista L, Van Kruchten M, Vaz SC, Fowler A, Linden H, Ulaner GA. Summary: SNMMI Procedure Standard/EANM Practice Guideline for Estrogen Receptor Imaging of Patients with Breast Cancer Using 16alpha-[18F]Fluoro-17beta-Estradiol PET. J Nucl Med. 2024 Feb 1;65(2):221-223. doi: 10.2967/jnumed.123.266938.

  PMID: 38071554 BACKGROUND

• 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 Oct;12(10):573-83. doi: 10.1038/nrclinonc.2015.117. Epub 2015 Jun 30.

  PMID: 26122181 BACKGROUND

• Bardia A, Cortes J, Bidard FC, Neven P, Garcia-Saenz J, Aftimos P, O'Shaughnessy J, Lu J, Tonini G, Scartoni S, Paoli A, Binaschi M, Wasserman T, Kaklamani V. Elacestrant in ER+, HER2- Metastatic Breast Cancer with ESR1-Mutated Tumors: Subgroup Analyses from the Phase III EMERALD Trial by Prior Duration of Endocrine Therapy plus CDK4/6 Inhibitor and in Clinical Subgroups. Clin Cancer Res. 2024 Oct 1;30(19):4299-4309. doi: 10.1158/1078-0432.CCR-24-1073.

  PMID: 39087959 BACKGROUND

• Cardoso F, Paluch-Shimon S, Schumacher-Wulf E, Matos L, Gelmon K, Aapro MS, Bajpai J, Barrios CH, Bergh J, Bergsten-Nordstrom E, Biganzoli L, Cardoso MJ, Carey LA, Chavez-MacGregor M, Chidebe R, Cortes J, Curigliano G, Dent RA, El Saghir NS, Eniu A, Fallowfield L, Francis PA, Franco Millan SX, Gilchrist J, Gligorov J, Gradishar WJ, Haidinger R, Harbeck N, Hu X, Kaur R, Kiely B, Kim SB, Koppikar S, Kuper-Hommel MJJ, Lecouvet FE, Mason G, Mertz SA, Mueller V, Myerson C, Neciosup S, Offersen BV, Ohno S, Pagani O, Partridge AH, Penault-Llorca F, Prat A, Rugo HS, Senkus E, Sledge GW, Swain SM, Thomssen C, Vorobiof DA, Vuylsteke P, Wiseman T, Xu B, Costa A, Norton L, Winer EP. 6th and 7th International consensus guidelines for the management of advanced breast cancer (ABC guidelines 6 and 7). Breast. 2024 Aug;76:103756. doi: 10.1016/j.breast.2024.103756. Epub 2024 May 28.

  PMID: 38896983 BACKGROUND

• Andre F, Solovieff N, Su F, Bardia A, Neven P, Yap YS, Tripathy D, Lu YS, Slamon D, Chia S, Joshi M, Chakravartty A, Lteif A, Taran T, Arteaga CL. Acquired gene alterations in patients treated with ribociclib plus endocrine therapy or endocrine therapy alone using baseline and end-of-treatment circulating tumor DNA samples in the MONALEESA-2, -3, and -7 trials. Ann Oncol. 2025 Jan;36(1):54-64. doi: 10.1016/j.annonc.2024.09.010. Epub 2024 Sep 21.

  PMID: 39313156 BACKGROUND

• AlFakeeh A, Brezden-Masley C. Overcoming endocrine resistance in hormone receptor-positive breast cancer. Curr Oncol. 2018 Jun;25(Suppl 1):S18-S27. doi: 10.3747/co.25.3752. Epub 2018 Jun 13.

  PMID: 29910644 BACKGROUND

• Brett JO, Spring LM, Bardia A, Wander SA. ESR1 mutation as an emerging clinical biomarker in metastatic hormone receptor-positive breast cancer. Breast Cancer Res. 2021 Aug 15;23(1):85. doi: 10.1186/s13058-021-01462-3.

  PMID: 34392831 BACKGROUND

• Rugo HS, Lerebours F, Ciruelos E, Drullinsky P, Ruiz-Borrego M, Neven P, Park YH, Prat A, Bachelot T, Juric D, Turner N, Sophos N, Zarate JP, Arce C, Shen YM, Turner S, Kanakamedala H, Hsu WC, Chia S. 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. 2024 Dec;25(12):e629-e638. doi: 10.1016/S1470-2045(24)00673-9.

  PMID: 39637900 BACKGROUND

• Andre F, Ciruelos E, Rubovszky G, Campone M, Loibl S, Rugo HS, Iwata H, Conte P, Mayer IA, Kaufman B, Yamashita T, Lu YS, Inoue K, Takahashi M, Papai Z, Longin AS, Mills D, Wilke C, Hirawat S, Juric D; SOLAR-1 Study Group. Alpelisib for PIK3CA-Mutated, Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2019 May 16;380(20):1929-1940. doi: 10.1056/NEJMoa1813904.

  PMID: 31091374 BACKGROUND

• Vasseur A, Cabel L, Hego C, Takka W, Trabelsi Grati O, Renouf B, Lerebours F, Loirat D, Brain E, Cottu P, Sablin MP, Pierga JY, Callens C, Renault S, Bidard FC. Fulvestrant and everolimus efficacy after CDK4/6 inhibitor: a prospective study with circulating tumor DNA analysis. Oncogene. 2024 Apr;43(16):1214-1222. doi: 10.1038/s41388-024-02986-6. Epub 2024 Feb 27.

  PMID: 38413796 BACKGROUND

• Piccart M, Hortobagyi GN, Campone M, Pritchard KI, Lebrun F, Ito Y, Noguchi S, Perez A, Rugo HS, Deleu I, Burris HA 3rd, Provencher L, Neven P, Gnant M, Shtivelband M, Wu C, Fan J, Feng W, Taran T, Baselga J. Everolimus plus exemestane for hormone-receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: overall survival results from BOLERO-2dagger. Ann Oncol. 2014 Dec;25(12):2357-2362. doi: 10.1093/annonc/mdu456. Epub 2014 Sep 17.

  PMID: 25231953 BACKGROUND

• Baselga J, Campone M, Piccart M, Burris HA 3rd, Rugo HS, Sahmoud T, Noguchi S, Gnant M, Pritchard KI, Lebrun F, Beck JT, Ito Y, Yardley D, Deleu I, Perez A, Bachelot T, Vittori L, Xu Z, Mukhopadhyay P, Lebwohl D, Hortobagyi GN. Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med. 2012 Feb 9;366(6):520-9. doi: 10.1056/NEJMoa1109653. Epub 2011 Dec 7.

  PMID: 22149876 BACKGROUND

• Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, Campone M, Blackwell KL, Andre F, Winer EP, Janni W, Verma S, Conte P, Arteaga CL, Cameron DA, Petrakova K, Hart LL, Villanueva C, Chan A, Jakobsen E, Nusch A, Burdaeva O, Grischke EM, Alba E, Wist E, Marschner N, Favret AM, Yardley D, Bachelot T, Tseng LM, Blau S, Xuan F, Souami F, Miller M, Germa C, Hirawat S, O'Shaughnessy J. Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer. N Engl J Med. 2016 Nov 3;375(18):1738-1748. doi: 10.1056/NEJMoa1609709. Epub 2016 Oct 7.

  PMID: 27717303 BACKGROUND

• Trapani D, Martins-Branco D, Curigliano G, Gennari A, Pentheroudakis G, Harbeck N; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Updated treatment recommendations for systemic treatment: from the ESMO Metastatic Breast Cancer Living Guideline. Ann Oncol. 2025 Nov;36(11):1414-1418. doi: 10.1016/j.annonc.2025.07.017. Epub 2025 Aug 12. No abstract available.

  PMID: 40930896 BACKGROUND

• Wolff AC, Hammond ME, Hicks DG, Dowsett M, McShane LM, Allison KH, Allred DC, Bartlett JM, Bilous M, Fitzgibbons P, Hanna W, Jenkins RB, Mangu PB, Paik S, Perez EA, Press MF, Spears PA, Vance GH, Viale G, Hayes DF; American Society of Clinical Oncology; College of American Pathologists. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update. Arch Pathol Lab Med. 2014 Feb;138(2):241-56. doi: 10.5858/arpa.2013-0953-SA. Epub 2013 Oct 7.

  PMID: 24099077 BACKGROUND

• Chandarlapaty S, Chen D, He W, Sung P, Samoila A, You D, Bhatt T, Patel P, Voi M, Gnant M, Hortobagyi G, Baselga J, Moynahan ME. 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 Oct 1;2(10):1310-1315. doi: 10.1001/jamaoncol.2016.1279.

  PMID: 27532364 BACKGROUND

• Andre F, Ciruelos EM, Juric D, Loibl S, Campone M, Mayer IA, Rubovszky G, Yamashita T, Kaufman B, Lu YS, Inoue K, Papai Z, Takahashi M, Ghaznawi F, Mills D, Kaper M, Miller M, Conte PF, Iwata H, Rugo HS. 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 Feb;32(2):208-217. doi: 10.1016/j.annonc.2020.11.011. Epub 2020 Nov 25.

  PMID: 33246021 BACKGROUND

• Lobo-Martins SL, Branco DM, Aftimos PG, et al. 355P EVERolimus effectiveness after proGREssion on CDK4/6 inhibitors for ENdocrine receptor-positive/HER2-negative, advanced breast cancer: EVERGREEN quasi-experimental study. Annals of Oncology. 2024;35:S365-S366.

  BACKGROUND

• Wolff AC, Hammond MEH, Allison KH, Harvey BE, Mangu PB, Bartlett JMS, Bilous M, Ellis IO, Fitzgibbons P, Hanna W, Jenkins RB, Press MF, Spears PA, Vance GH, Viale G, McShane LM, Dowsett M. Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update. J Clin Oncol. 2018 Jul 10;36(20):2105-2122. doi: 10.1200/JCO.2018.77.8738. Epub 2018 May 30.

  PMID: 29846122 BACKGROUND

• Allison KH, Hammond MEH, Dowsett M, McKernin SE, Carey LA, Fitzgibbons PL, Hayes DF, Lakhani SR, Chavez-MacGregor M, Perlmutter J, Perou CM, Regan MM, Rimm DL, Symmans WF, Torlakovic EE, Varella L, Viale G, Weisberg TF, McShane LM, Wolff AC. Estrogen and Progesterone Receptor Testing in Breast Cancer: ASCO/CAP Guideline Update. J Clin Oncol. 2020 Apr 20;38(12):1346-1366. doi: 10.1200/JCO.19.02309. Epub 2020 Jan 13.

  PMID: 31928404 BACKGROUND

• Gennari A, Andre F, Barrios CH, Cortes J, de Azambuja E, DeMichele A, Dent R, Fenlon D, Gligorov J, Hurvitz SA, Im SA, Krug D, Kunz WG, Loi S, Penault-Llorca F, Ricke J, Robson M, Rugo HS, Saura C, Schmid P, Singer CF, Spanic T, Tolaney SM, Turner NC, Curigliano G, Loibl S, Paluch-Shimon S, Harbeck N; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. ESMO Clinical Practice Guideline for the diagnosis, staging and treatment of patients with metastatic breast cancer. Ann Oncol. 2021 Dec;32(12):1475-1495. doi: 10.1016/j.annonc.2021.09.019. Epub 2021 Oct 19. No abstract available.

  PMID: 34678411 BACKGROUND

• Loibl S, Andre F, Bachelot T, Barrios CH, Bergh J, Burstein HJ, Cardoso MJ, Carey LA, Dawood S, Del Mastro L, Denkert C, Fallenberg EM, Francis PA, Gamal-Eldin H, Gelmon K, Geyer CE, Gnant M, Guarneri V, Gupta S, Kim SB, Krug D, Martin M, Meattini I, Morrow M, Janni W, Paluch-Shimon S, Partridge A, Poortmans P, Pusztai L, Regan MM, Sparano J, Spanic T, Swain S, Tjulandin S, Toi M, Trapani D, Tutt A, Xu B, Curigliano G, Harbeck N; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Early breast cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2024 Feb;35(2):159-182. doi: 10.1016/j.annonc.2023.11.016. Epub 2023 Dec 13. No abstract available.

  PMID: 38101773 BACKGROUND

• Abdelwahab Yousef AJ. Male Breast Cancer: Epidemiology and Risk Factors. Semin Oncol. 2017 Aug;44(4):267-272. doi: 10.1053/j.seminoncol.2017.11.002. Epub 2017 Nov 9.

  PMID: 29526255 BACKGROUND

• Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024 Jan-Feb;74(1):12-49. doi: 10.3322/caac.21820. Epub 2024 Jan 17.

  PMID: 38230766 BACKGROUND

• Bardia A, Chandarlapaty S, Linden HM, Ulaner GA, Gosselin A, Cartot-Cotton S, Cohen P, Doroumian S, Paux G, Celanovic M, Pelekanou V, Ming JE, Ternes N, Bouaboula M, Lee JS, Bauchet AL, Campone M. AMEERA-1 phase 1/2 study of amcenestrant, SAR439859, in postmenopausal women with ER-positive/HER2-negative advanced breast cancer. Nat Commun. 2022 Jul 15;13(1):4116. doi: 10.1038/s41467-022-31668-8.

  PMID: 35840573 BACKGROUND

• Cancer Today

  BACKGROUND

MeSH Terms

Interventions

elacestrant

Study Officials

• Martine Piccart, MD, PhD

  Jules Bordet Institute

  STUDY CHAIR

Central Study Contacts

Tabatha Delsaute

CONTACT

+32 (0)2 541 34 56; irena.ctc@hubruxelles.be

Margot Morelle

CONTACT

+32 (0)2 541 39 76; irena.ctc@hubruxelles.be

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): September 13, 2026
• Primary Completion (Estimated): August 19, 2031
• Study Completion (Estimated): August 19, 2031
• Last Updated: August 10, 2026

Record last verified: 2026-08