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ER+ / HER2- Advanced Breast CancerPhase 2IRENANCT07753954

Medical Imaging to Re-evaluate Elacestrant Clinical Usage

A Phase 2 study testing Elacestrant in people with ER+ / HER2- Advanced Breast Cancer, run by Jules Bordet Institute.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
ER+ / HER2- Advanced Breast Cancer
What is being tested?
Elacestrant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
No sites listed yet
Study dates
13 Sep 2026to 19 Aug 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 31Show fewer
  • 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.
  • a) Patients will not be selected when treated with SERMs or SERDs ≤ 5 weeks prior to inclusion as these drugs interfere with the accessibility of the ER.
  • 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.
  • Female participants must be post-menopausal women, defined by 1 of the following criteria:
  • a) Prior bilateral oophorectomy (≥ 28 days prior to Day 1 of treatment).
  • b) Age ≥ 60 years with amenorrhea ≥ 1 year since last menses.
  • c) Age < 60 years: i. Cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; OR ii. serum oestradiol and/or FSH levels within the laboratory's reference range for post-menopausal females
  • d) Pre- or perimenopausal women, who do not meet the criteria for post-menopausal status must be concurrently receiving a LHRH analogue (goserelin), as per standard of care, for at least 28 days (if shorter, post-menopausal levels of serum oestradiol/FSH must be confirmed analytically) prior to study enrolment and are planning to continue LHRH agonist treatment during the study.
  • Resolution of all toxic effects of prior therapies or surgical procedures to Grade ≤ 1 (except for toxicities not considered a safety risk for the patient at Investigator's discretion).
  • Adequate organ function as defined below:
  • a) Haematologic function: i. Absolute neutrophil count ≥ 1.0 x 109/L. ii. Platelet count ≥ 75 x 109/L. iii. Haemoglobin ≥ 9.0 g/dL.
  • b) Renal function: i. Estimated glomerular filtration rate ≥30 mL/min/1.73 m2 or creatinine. clearance calculated by Cockcroft-Gault equation ≥ 30 mL/min.
  • c) Hepatic function i. Alanine aminotransferase (ALT) ≤ 3x upper limit of normal (ULN; in the presence of liver metastases, ALT ≤ 5x ULN).
  • Total bilirubin ≤ ULN or total bilirubin ≤ 1.5x ULN with direct bilirubin ≤ ULN of the laboratory in participants with documented Gilbert's Syndrome.
  • d) Chemistry i. Potassium, sodium, calcium (corrected for albumin), magnesium, and phosphorus NCI CTCAE v6.0 Grade ≤ 1. If screening assessments are abnormal, chemistry assessments may be repeated up to 2 times; participants may receive appropriate supplementation or treatment (e.g., for hypercalcemia) prior to re-assessment e) Coagulation i. International normalized ratio (INR) ≤ 1.5
  • Subject is willing and able to comply with the protocol for the duration of the study including treatment and scheduled visits and examinations.
  • Signed Informed Consent Form (ICF) obtained prior to any study related procedure.
  • Affiliated to the French Social Security System (applicable only to participants treated in France)

Who cannot join

  • 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.
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  • 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.
  • b) Treatment with an anticoagulant, e.g., warfarin or heparin, for a thrombotic event occurring > 6 months before enrolment, or for an otherwise stable and allowed medical condition (e.g., well controlled atrial fibrillation), provided dose and coagulation parameters (as defined by local standard of care) are stable for at least 28 days prior to the first dose of study drug and provided that an AI would be an appropriate therapy for the subject.
  • Known difficulty in tolerating oral medications or conditions which would impair absorption of oral medications such as: uncontrolled nausea or vomiting (i.e., CTCAE ≥ Grade 3 despite antiemetic therapy), ongoing gastrointestinal obstruction/motility disorder, malabsorption syndrome, or prior gastric bypass.
  • Unable or unwilling to avoid prescription medications, over-the-counter medications, dietary/herbal supplements (e.g., St. John's wort), and/or foods (e.g., grapefruit, pomelos, star fruit, Seville oranges and their juices) that are moderate/strong inhibitors or inducers of CYP3A4 activity (Appendix 1). Participation will be allowed if the medication, supplements, and/or foods are discontinued for at least 5 half-lives or 14 days (whichever is longer) prior to initiation of study treatment study enrolment and for the duration of the study.
  • Major surgery < 28 days before the first dose of study drug
  • Pregnant and/or lactating women, or intending to become pregnant during the study.
  • Women of childbearing potential refusing to use 1 highly effective method of contraception prior study entry, during the course of the study and at least 120 days after the last administration of study treatment.
  • Men with childbearing potential partner refusing to use condom during the course of this study and for at least 120 days after the last administration of the study treatment.
  • Participant with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.
  • Known hypersensitivity reactions to the study drugs or to any excipients.
  • Vulnerable persons according to the article L.1121-6 of the "Code de la Santé Publique" (CSP), adults who are the subject of a measure of legal protection or unable to express their consent according to article L.1121-8 of the CSP.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

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

About this study

Official title: Imaging to Re-evaluate Elacestrant Clinical Application

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:

Read more
  • 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
Being tested
Elacestrant
Keywords
Advanced breast cancer, ER+, HER2-, Elacestrant, Imaging

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ElacestrantDrug

    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.

Study groups in NCT07753954
Study groupRoleWhat they receive
Elacestrant Treatment for ER-Positive, HER2-Negative Breast Cancer Without ESR1 MutationExperimentalNot described
Receives: Drug: Elacestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (7)

  1. 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)

    To determine the efficacy of elacestrant, PFS, by central review as per RECIST v1.143/ PERCIST39,44 by 18F-FES-PET/CT result.

    Measured: 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)

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

    To evaluate the efficacy of elacestrant, by objective response rate (ORR), in the full analysis set and by 18F-FES-PET/CT result.

    Measured: 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)

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

    To evaluate the efficacy of elacestrant, by OS, in the full analysis set and by 18F-FES PET/CT result.

    Measured: 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)

  4. PFS and OS rates at 6-month and at 12-month

    To determine the efficacy of elacestrant by PFS and OS at landmark timepoints of 6stuyd-month and 12-month rate.

    Measured: 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)

  5. 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.

    To evaluate the impact of 18F-FES-PET/CT homogeneity on time to subsequent chemotherapy.

    Measured: 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)

  6. Association between 18F-FES-PET/CT heterogeneity score and progression-free survival in participants treated with elacestrant.

    To retrospectively find the optimal 18F-FES-PET/CT homogeneity threshold to demonstrate the superiority in PFS in participants treated with elacestrant.

    Measured: 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)

  7. Incidence, nature, and severity of adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 6.0 (NCI CTCAE, v6.0).

    To evaluate the safety and tolerability of elacestrant.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2026
  2. Study start13 Sep 2026 (estimated)
  3. Primary completion19 Aug 2031 (estimated)
  4. Study completion19 Aug 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07753954
Sponsor's protocol ID
IJB-IRENA-2025
Other IDs
2025-524380-20, 2025
Acronym
IRENA
Status last verified
Aug 2026
First submitted
17 Apr 2026
Last updated
10 Aug 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 19403881

  • 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.

    PubMed 19097774

  • 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.

    PubMed 39848768

  • 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).

  • 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.

    PubMed 26985059

  • 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.

    PubMed 39098453

  • 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.

    PubMed 38423389

  • 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.

    PubMed 36028895

  • 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.

    PubMed 36735488

  • 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.

    PubMed 24079874

  • 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.

    PubMed 27307345

  • 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.

    PubMed 32601772

  • 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.

    PubMed 38693453

  • 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.

    PubMed 38071554

  • 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.

    PubMed 26122181

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Elacestrant in people with ER+ / HER2- Advanced Breast Cancer, run by Jules Bordet Institute.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tabatha Delsaute (+32 (0)2 541 34 56, irena.ctc@hubruxelles.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival in participants with ESR1-mut-nd (time frame: From first day of treatment until 6 months after first day of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07753954, which also lists 39 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

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