ESR1 Gene MutationΗΕ 11ESR1/24NCT07899463
ESR1 Mutations in Metastatic Hormone Receptor-Positive Breast Cancer in the Greek Population
An observational study of ESR1 Gene Mutation and Breast Cancer (Locally Advanced or Metastatic), run by Hellenic Cooperative Oncology Group at 1 site in Greece.
Trial summary
The goal of this observational study is to assess the prevalence of ESR1 mutations in patients with metastatic hormone receptor-positive/HER2-negative breast cancer in Greece and evaluate the associations of these mutations with disease characteristics, clinical outcomes and real-world treatment patterns. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ESR1 Gene Mutation, Breast Cancer (Locally Advanced or Metastatic), Hormon Receptor Positive Breast Cancer
- How many people
- 500 participants
- Where
- 1 siteGreece
- Study dates
- 13 May 2025to 15 Oct 2027
- Phase
- Observational
- 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
Study population: The study population includes patients with metastatic hormone receptor-positive (HR+) breast cancer in Greece who have been tested for ESR1 mutations. Patients are enrolled from routine clinical practice, including both retrospective and prospective data collection. All treatments follow standard clinical practice, and no additional interventions or study-specific procedures are required. Data collected include ESR1 mutation status (via NGS liquid biopsy), clinicopathological characteristics, and treatment patterns
Who may be able to join
- Male or female patients, regardless of race, residing in Greece, aged 18 years or older at the start of treatment.
- Patients with histologically confirmed metastatic breast cancer with positive hormone receptors and negative HER2 status.
- Patients undergoing ESR1 mutation testing.
Who cannot join
- Patients with metastatic hormone receptor-positive breast cancer who have not undergone ESR1 mutation testing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maria Moschoni contact
Greece1 site, 1 recruiting
- Recruiting
Hellenic Cooperative Oncology Group
Athens
Hellenic Cooperative Oncology Group Hellenic Cooperative Oncology Group, +302106912520, hecogoff@otenet.gr
Eleni Galani
About this study
Official title: Recording ESR1 Mutations in Metastatic Hormone Receptor-Positive Breast Cancer in the Greek Population: A Non-Interventional, Retrospective and Prospective Observational Study of Clinical Practice Data and Treatment Utilization Patterns in Routine Care
The goal of this observational study is to assess the prevalence of ESR1 mutations in patients with metastatic hormone receptor-positive/HER2-negative breast cancer in Greece and evaluate the associations of these mutations with disease characteristics, clinical outcomes and real-world treatment patterns.
This study will include participants who have already undergone ESR1 testing as part of their standard medical care. Patient real-world data will be extracted by the patient's medical records. No additional procedures or visits beyond routine care will be required. Data will be collected from routine clinical visits and standard-of-care treatment.
Read the detailed description
This is a non-interventional, retrospective and prospective observational study conducted in routine clinical practice in Greece with the support of the Hellenic Cooperative Oncology Group. The study involves the collection of primary data from oncology centers, including a representative sample of patients receiving standard-of-care treatment. No changes to current therapeutic practice are required, and all patient management will follow local clinical standards under the discretion of participating physicians.
Eligible participants are patients aged 18 years or older, with histologically confirmed metastatic hormone receptor-positive, HER2-negative breast cancer who undergo ESR1 mutation testing.
The primary endpoint of the study is the epidemiology of ESR1 mutations in the Greek population of patients with metastatic hormone receptor-positive breast cancer, while secondary endpoints include the association of ESR1 mutations with the number and type of prior therapies and correlation with other biomarkers.
Clinical data will be extracted from patients' medical records. Personal identifiers will be pseudonymized, coded, and assigned a unique identification number to protect patient privacy. For the retrospective portion of the study, approval will be obtained from the hospital Scientific Board for patients who are no longer alive, under a waiver of consent.
Patients who consent to participate in optional translational research may provide biological material for further study. This may include paraffin-embedded tumor tissue blocks, surgical specimens, H\&E slides for molecular tumor characterization or digitization for deep learning-based biomarker prediction, and swab samples for germline mutation analysis, provided the patient is alive.
The study will be conducted in accordance with Good Pharmacovigilance Practice, the European General Data Protection Regulation (GDPR), and applicable local regulatory requirements.
- Conditions
- ESR1 Gene Mutation, Breast Cancer (Locally Advanced or Metastatic), Hormon Receptor Positive Breast Cancer
- Keywords
- Breast cancer, ESR1 mutation, tumor molecular profiling, Liquid biopsy
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Metastatic HR+ Breast Cancer ESR1 Cohort | Patients with metastatic HR-positive/HER2-negative breast cancer in Greece who have been tested for ESR1 mutations. Data collected include ESR1 mutation status (via NGS liquid biopsy), clinicopathological features, and treatment patterns in routine clinical practice. No changes to standard therapy are required, and data collection occurs only during routine clinical visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of ESR1 mutations
The proportion of patients with metastatic HR+/HER2- breast cancer in Greece who have detectable ESR1 mutations, determined by next-generation sequencing (NGS) of circulating tumor DNA (liquid biopsy) among all patients tested. Data are collected retrospectively and prospectively from routine clinical visits.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Association of ESR1 mutations with clinicopathological features
Correlation of ESR1 mutation status with patient demographics, tumor subtype, prior therapies, disease progression, and other clinicopathological characteristics observed in routine clinical practice.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start13 May 2025
- Primary completion15 May 2027 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ESR1 Gene MutationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hellenic Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899463
- Sponsor's protocol ID
- ΗΕ 11ESR1/24
- Acronym
- ΗΕ 11ESR1/24
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bidard FC, Kaklamani VG, Neven P, Streich G, Montero AJ, Forget F, Mouret-Reynier MA, Sohn JH, Taylor D, Harnden KK, Khong H, Kocsis J, Dalenc F, Dillon PM, Babu S, Waters S, Deleu I, Garcia Saenz JA, Bria E, Cazzaniga M, Lu J, Aftimos P, Cortes J, Liu S, Tonini G, Laurent D, Habboubi N, Conlan MG, Bardia A. 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 Oct 1;40(28):3246-3256. doi: 10.1200/JCO.22.00338. Epub 2022 May 18.
PubMed 35584336Merenbakh-Lamin K, Ben-Baruch N, Yeheskel A, Dvir A, Soussan-Gutman L, Jeselsohn R, Yelensky R, Brown M, Miller VA, Sarid D, Rizel S, Klein B, Rubinek T, Wolf I. D538G mutation in estrogen receptor-alpha: A novel mechanism for acquired endocrine resistance in breast cancer. Cancer Res. 2013 Dec 1;73(23):6856-64. doi: 10.1158/0008-5472.CAN-13-1197. Epub 2013 Nov 11.
PubMed 24217577Jeselsohn R, Yelensky R, Buchwalter G, Frampton G, Meric-Bernstam F, Gonzalez-Angulo AM, Ferrer-Lozano J, Perez-Fidalgo JA, Cristofanilli M, Gomez H, Arteaga CL, Giltnane J, Balko JM, Cronin MT, Jarosz M, Sun J, Hawryluk M, Lipson D, Otto G, Ross JS, Dvir A, Soussan-Gutman L, Wolf I, Rubinek T, Gilmore L, Schnitt S, Come SE, Pusztai L, Stephens P, Brown M, Miller VA. Emergence of constitutively active estrogen receptor-alpha mutations in pretreated advanced estrogen receptor-positive breast cancer. Clin Cancer Res. 2014 Apr 1;20(7):1757-1767. doi: 10.1158/1078-0432.CCR-13-2332. Epub 2014 Jan 7.
PubMed 24398047Li S, Shen D, Shao J, Crowder R, Liu W, Prat A, He X, Liu S, Hoog J, Lu C, Ding L, Griffith OL, Miller C, Larson D, Fulton RS, Harrison M, Mooney T, McMichael JF, Luo J, Tao Y, Goncalves R, Schlosberg C, Hiken JF, Saied L, Sanchez C, Giuntoli T, Bumb C, Cooper C, Kitchens RT, Lin A, Phommaly C, Davies SR, Zhang J, Kavuri MS, McEachern D, Dong YY, Ma C, Pluard T, Naughton M, Bose R, Suresh R, McDowell R, Michel L, Aft R, Gillanders W, DeSchryver K, Wilson RK, Wang S, Mills GB, Gonzalez-Angulo A, Edwards JR, Maher C, Perou CM, Mardis ER, Ellis MJ. Endocrine-therapy-resistant ESR1 variants revealed by genomic characterization of breast-cancer-derived xenografts. Cell Rep. 2013 Sep 26;4(6):1116-30. doi: 10.1016/j.celrep.2013.08.022. Epub 2013 Sep 19.
PubMed 24055055Toy W, Shen Y, Won H, Green B, Sakr RA, Will M, Li Z, Gala K, Fanning S, King TA, Hudis C, Chen D, Taran T, Hortobagyi G, Greene G, Berger M, Baselga J, Chandarlapaty S. ESR1 ligand-binding domain mutations in hormone-resistant breast cancer. Nat Genet. 2013 Dec;45(12):1439-45. doi: 10.1038/ng.2822. Epub 2013 Nov 3.
PubMed 24185512Robinson DR, Wu YM, Vats P, Su F, Lonigro RJ, Cao X, Kalyana-Sundaram S, Wang R, Ning Y, Hodges L, Gursky A, Siddiqui J, Tomlins SA, Roychowdhury S, Pienta KJ, Kim SY, Roberts JS, Rae JM, Van Poznak CH, Hayes DF, Chugh R, Kunju LP, Talpaz M, Schott AF, Chinnaiyan AM. Activating ESR1 mutations in hormone-resistant metastatic breast cancer. Nat Genet. 2013 Dec;45(12):1446-51. doi: 10.1038/ng.2823. Epub 2013 Nov 3.
PubMed 24185510Zhang QX, Borg A, Wolf DM, Oesterreich S, Fuqua SA. An estrogen receptor mutant with strong hormone-independent activity from a metastatic breast cancer. Cancer Res. 1997 Apr 1;57(7):1244-9.
PubMed 9102207Hermida-Prado F, Jeselsohn R. The ESR1 Mutations: From Bedside to Bench to Bedside. Cancer Res. 2021 Feb 1;81(3):537-538. doi: 10.1158/0008-5472.CAN-20-4037.
PubMed 33526469Nagaraj G, Ma CX. Clinical Challenges in the Management of Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer: A Literature Review. Adv Ther. 2021 Jan;38(1):109-136. doi: 10.1007/s12325-020-01552-2. Epub 2020 Nov 15.
PubMed 33190190
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recording ESR1 Mutations in Metastatic Hormone Receptor-Positive Breast Cancer in the Greek Population: A Non-Interventional, Retrospective and Prospective Observational Study of Clinical Practice Data and Treatment Utilization Patterns in Routine Care
- ClinicalTrials.gov ID
- NCT07899463
- Acronym / sponsor ID
- ΗΕ 11ESR1/24 / ΗΕ 11ESR1/24
- Conditions
- ESR1 Gene Mutation, Breast Cancer (Locally Advanced or Metastatic), Hormon Receptor Positive Breast Cancer
- Keywords
- Breast cancer, ESR1 mutation, tumor molecular profiling, Liquid biopsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hellenic Cooperative Oncology GroupUniversity, hospital or other
- Study start
- 13 May 2025 (actual)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 15 Oct 2027 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to assess the prevalence of ESR1 mutations in patients with metastatic hormone receptor-positive/HER2-negative breast cancer in Greece and evaluate the associations of these mutations with disease characteristics, clinical outcomes and real-world treatment patterns.
This study will include participants who have already undergone ESR1 testing as part of their standard medical care. Patient real-world data will be extracted by the patient's medical records. No additional procedures or visits beyond routine care will be required. Data will be collected from routine clinical visits and standard-of-care treatment.
Detailed description
This is a non-interventional, retrospective and prospective observational study conducted in routine clinical practice in Greece with the support of the Hellenic Cooperative Oncology Group. The study involves the collection of primary data from oncology centers, including a representative sample of patients receiving standard-of-care treatment. No changes to current therapeutic practice are required, and all patient management will follow local clinical standards under the discretion of participating physicians.
Eligible participants are patients aged 18 years or older, with histologically confirmed metastatic hormone receptor-positive, HER2-negative breast cancer who undergo ESR1 mutation testing.
The primary endpoint of the study is the epidemiology of ESR1 mutations in the Greek population of patients with metastatic hormone receptor-positive breast cancer, while secondary endpoints include the association of ESR1 mutations with the number and type of prior therapies and correlation with other biomarkers.
Clinical data will be extracted from patients' medical records. Personal identifiers will be pseudonymized, coded, and assigned a unique identification number to protect patient privacy. For the retrospective portion of the study, approval will be obtained from the hospital Scientific Board for patients who are no longer alive, under a waiver of consent.
Patients who consent to participate in optional translational research may provide biological material for further study. This may include paraffin-embedded tumor tissue blocks, surgical specimens, H\&E slides for molecular tumor characterization or digitization for deep learning-based biomarker prediction, and swab samples for germline mutation analysis, provided the patient is alive.
The study will be conducted in accordance with Good Pharmacovigilance Practice, the European General Data Protection Regulation (GDPR), and applicable local regulatory requirements.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic HR+ Breast Cancer ESR1 Cohort | – | –Patients with metastatic HR-positive/HER2-negative breast cancer in Greece who have been tested for ESR1 mutations. Data collected include ESR1 mutation status (via NGS liquid biopsy), clinicopathological features, and treatment patterns in routine clinical practice. No changes to standard therapy are required, and data collection occurs only during routine clinical visits |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes patients with metastatic hormone receptor-positive (HR+) breast cancer in Greece who have been tested for ESR1 mutations. Patients are enrolled from routine clinical practice, including both retrospective and prospective data collection. All treatments follow standard clinical practice, and no additional interventions or study-specific procedures are required. Data collected include ESR1 mutation status (via NGS liquid biopsy), clinicopathological characteristics, and treatment patterns
Key inclusion criteria (3 listed)
- Male or female patients, regardless of race, residing in Greece, aged 18 years or older at the start of treatment.
- Patients with histologically confirmed metastatic breast cancer with positive hormone receptors and negative HER2 status.
- Patients undergoing ESR1 mutation testing.
Key exclusion criteria (1 listed)
- Patients with metastatic hormone receptor-positive breast cancer who have not undergone ESR1 mutation testing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of ESR1 mutations
Time frame: through study completion, an average of 1 year
The proportion of patients with metastatic HR+/HER2- breast cancer in Greece who have detectable ESR1 mutations, determined by next-generation sequencing (NGS) of circulating tumor DNA (liquid biopsy) among all patients tested. Data are collected retrospectively and prospectively from routine clinical visits.
1 secondary outcome
Association of ESR1 mutations with clinicopathological features
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 35584336Bidard FC, Kaklamani VG, Neven P, Streich G, Montero AJ, Forget F, Mouret-Reynier MA, Sohn JH, Taylor D, Harnden KK, Khong H, Kocsis J, Dalenc F, Dillon PM, Babu S, Waters S, Deleu I, Garcia Saenz JA, Bria E, Cazzaniga M, Lu J, Aftimos P, Cortes J, Liu S, Tonini G, Laurent D, Habboubi N, Conlan MG, Bardia A. 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 Oct 1;40(28):3246-3256. doi: 10.1200/JCO.22.00338. Epub 2022 May 18.
- Background: PubMed 24217577Merenbakh-Lamin K, Ben-Baruch N, Yeheskel A, Dvir A, Soussan-Gutman L, Jeselsohn R, Yelensky R, Brown M, Miller VA, Sarid D, Rizel S, Klein B, Rubinek T, Wolf I. D538G mutation in estrogen receptor-alpha: A novel mechanism for acquired endocrine resistance in breast cancer. Cancer Res. 2013 Dec 1;73(23):6856-64. doi: 10.1158/0008-5472.CAN-13-1197. Epub 2013 Nov 11.
- Background: PubMed 24398047Jeselsohn R, Yelensky R, Buchwalter G, Frampton G, Meric-Bernstam F, Gonzalez-Angulo AM, Ferrer-Lozano J, Perez-Fidalgo JA, Cristofanilli M, Gomez H, Arteaga CL, Giltnane J, Balko JM, Cronin MT, Jarosz M, Sun J, Hawryluk M, Lipson D, Otto G, Ross JS, Dvir A, Soussan-Gutman L, Wolf I, Rubinek T, Gilmore L, Schnitt S, Come SE, Pusztai L, Stephens P, Brown M, Miller VA. Emergence of constitutively active estrogen receptor-alpha mutations in pretreated advanced estrogen receptor-positive breast cancer. Clin Cancer Res. 2014 Apr 1;20(7):1757-1767. doi: 10.1158/1078-0432.CCR-13-2332. Epub 2014 Jan 7.
- Background: PubMed 24055055Li S, Shen D, Shao J, Crowder R, Liu W, Prat A, He X, Liu S, Hoog J, Lu C, Ding L, Griffith OL, Miller C, Larson D, Fulton RS, Harrison M, Mooney T, McMichael JF, Luo J, Tao Y, Goncalves R, Schlosberg C, Hiken JF, Saied L, Sanchez C, Giuntoli T, Bumb C, Cooper C, Kitchens RT, Lin A, Phommaly C, Davies SR, Zhang J, Kavuri MS, McEachern D, Dong YY, Ma C, Pluard T, Naughton M, Bose R, Suresh R, McDowell R, Michel L, Aft R, Gillanders W, DeSchryver K, Wilson RK, Wang S, Mills GB, Gonzalez-Angulo A, Edwards JR, Maher C, Perou CM, Mardis ER, Ellis MJ. Endocrine-therapy-resistant ESR1 variants revealed by genomic characterization of breast-cancer-derived xenografts. Cell Rep. 2013 Sep 26;4(6):1116-30. doi: 10.1016/j.celrep.2013.08.022. Epub 2013 Sep 19.
- Background: PubMed 24185512Toy W, Shen Y, Won H, Green B, Sakr RA, Will M, Li Z, Gala K, Fanning S, King TA, Hudis C, Chen D, Taran T, Hortobagyi G, Greene G, Berger M, Baselga J, Chandarlapaty S. ESR1 ligand-binding domain mutations in hormone-resistant breast cancer. Nat Genet. 2013 Dec;45(12):1439-45. doi: 10.1038/ng.2822. Epub 2013 Nov 3.
- Background: PubMed 24185510Robinson DR, Wu YM, Vats P, Su F, Lonigro RJ, Cao X, Kalyana-Sundaram S, Wang R, Ning Y, Hodges L, Gursky A, Siddiqui J, Tomlins SA, Roychowdhury S, Pienta KJ, Kim SY, Roberts JS, Rae JM, Van Poznak CH, Hayes DF, Chugh R, Kunju LP, Talpaz M, Schott AF, Chinnaiyan AM. Activating ESR1 mutations in hormone-resistant metastatic breast cancer. Nat Genet. 2013 Dec;45(12):1446-51. doi: 10.1038/ng.2823. Epub 2013 Nov 3.
- Background: PubMed 9102207Zhang QX, Borg A, Wolf DM, Oesterreich S, Fuqua SA. An estrogen receptor mutant with strong hormone-independent activity from a metastatic breast cancer. Cancer Res. 1997 Apr 1;57(7):1244-9.
- Background: PubMed 33526469Hermida-Prado F, Jeselsohn R. The ESR1 Mutations: From Bedside to Bench to Bedside. Cancer Res. 2021 Feb 1;81(3):537-538. doi: 10.1158/0008-5472.CAN-20-4037.
- Background: PubMed 33190190Nagaraj G, Ma CX. Clinical Challenges in the Management of Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer: A Literature Review. Adv Ther. 2021 Jan;38(1):109-136. doi: 10.1007/s12325-020-01552-2. Epub 2020 Nov 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Moschoni contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ESR1 Gene Mutation and Breast Cancer (Locally Advanced or Metastatic), run by Hellenic Cooperative Oncology Group at 1 site in Greece.
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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 Eleni Galani (+30 6944172478, eleni_galani@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of ESR1 mutations (time frame: through study completion, an average of 1 year). 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 NCT07899463, which also lists 9 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 27 Oct 2026.