Breast CancerELENINCT07563595
Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer
An observational study of Breast Cancer, run by iOMEDICO AG at 3 sites in Germany.
Trial summary
The objective of this non-interventional study (NIS) is to evaluate prevalence of ESR1 mutation after endocrine therapy in the palliative setting, quality of life, tolerability, and safety and to describe treatment detail and adverse event (AE) management in postmenopausal women with locally advanced and/or metastatic… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Elacestrant
- How many people
- 500 participants
- Where
- 3 sitesGermany
- Study dates
- 19 Jun 2026to Jun 2028
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Postmenopausal women with locally advanced and/or metastatic estrogen receptor-positive (ER+) human epidermal growth factor receptor 2-negative (HER2)- breast cancer with disease progression on endocrine therapy and cyclin-dependent kinase inhibitor (CDKi) and intention for second line (2L) treatment with elacestrant according to summary of product characteristics (SmPC).
Who may be able to join
- Signed and dated informed consent form
- Postmenopausal women
- Age ≥18 years
- Eastern Cooperative Oncology Group Performance Status (ECOG) < 2
- Locally advanced and/or metastatic ER+ HER2- breast cancer
- Histologically proven ER positivity (defined as ≥1% staining by immunohistochemistry (IHC))
Show all 10Show fewer
- Histologically proven HER2 negativity (defined as a IHC0 or IHC1+ score by IHC or a negative result by in situ hybridization (ISH), optionally combined with a IHC2+ score)
- Disease progression following first line ET + CDKi
- No more than one prior ET line in the advanced/metastatic setting and intention for 2nd-line treatment with elacestrant according to current elacestrant SmPC as assessed by the treating physician (ESR1 testing can be done after inclusion)
- For patients with proven ESR1mut: Study inclusion the latest 2 weeks after start of elacestrant treatment
Who cannot join
- Prior chemotherapy in the advanced/metastatic setting
- Contraindications according to elacestrant SmPC, except for ESR1 test result for patients included prior to ESR1 testing.
- Participation in an interventional clinical trial within 30 days prior to enrolment or simultaneous participation in an interventional clinical trial (except follow-up phase)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany3 sites, 3 recruiting
- Recruiting
Praxis für interdisziplinäre Onkologie & Hämatologie
Freiburg im Breisgau, 79110
Patrick Marschner, +49761386870, klifo@onkologie-freiburg.de
- Recruiting
St. Louise Frauen- und Kinderklinik
Paderborn, 33098
Michael P Lux, +49 5251864121, M.Lux@vincenz.de
- Recruiting
Gemeinschaftspraxis für Hämatologie und Onkologie
Ravensburg, 88212
Thomas Decker, +49 751 366197-0, thomas.decker@onkonet.eu
About this study
Official title: Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer: a Multicenter, National, Prospective Non-interventional Study
The objective of this non-interventional study (NIS) is to evaluate prevalence of ESR1 mutation after endocrine therapy in the palliative setting, quality of life, tolerability, and safety and to describe treatment detail and adverse event (AE) management in postmenopausal women with locally advanced and/or metastatic ER+ HER2- ESR1-mutated breast cancer and second line treatment with elacestrant according to SmPC (Summary of product characteristics) in a real-world setting.
- Conditions
- Breast Cancer
- Being tested
- Elacestrant, Standard of care (Investigator Choice)
- Keywords
- Elacestrant, advanced breast cancer, Quality of life, ESR1 Mutation, Orserdu
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElacestrantDrug
Also called Orserdu®
According to the Summary of Product Characteristics (SmPC)
Standard of care (Investigator Choice)Drug
Treatment decision of investigator
| Study group | Role | What they receive |
|---|---|---|
| ESR1 wildtype | Patients with a ESR1 wildtype tumor Receives: Drug: Standard of care (Investigator Choice) | |
| ESR1 mutated | Patients with a ESR1 mutated tumor Receives: Drug: Elacestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in EORTC global health scale
Change from baseline quality of life (QoL) over time for the global health scale of the EORTC QLQ- C30 questionnaire The EORTC QLQ- C30 global health scale ranges from 0 to 100, with higher scores indicating better quality of life.
Measured: From Time of enrollment until month 11
Secondary outcomes (36)
Time to deterioration in global health scale (EORTC QLQ-C30)
Time to deterioration in global health scale of EORTC QLQ-C30 The EORTC QLQ- C30 global health scale ranges from 0 to 100, with higher scores indicating better quality of life.
Measured: From Time of enrollment until month 11
Time to deterioration in functional scores (EORTC QLQ-C30)
Time to deterioration in functional scores of EORTC QLQ-C30. The EORTC QLQ- C30 functional score ranges from 0 to 100, with higher scores indicating better quality of life.
Measured: From Time of enrollment until month 11
Time to deterioration in symptom scores (EORTC QLQ-C30)
Time to deterioration in symptom scores of EORTC QLQ-C30 The EORTC QLQ- C30 symptom score ranges from 0 to 100, with lower scores indicating better quality of life.
Measured: From Time of enrollment until month 11
Change from baseline in functional and symptom scores
Change from baseline in functional and symptom scores of EORTC QLQ-C30 The EORTC QLQ- C30 functional and symptom scores ranges from 0 to 100, with higher scores indicating better quality of life (for functional scores), and lower indication better quality of life for symptom scores.
Measured: From Time of enrolment until up to 11 months after enrolment.
Change from baseline in visual analogue scale (VAS)
Change from baseline in EQ-5D-5L visual analogue scale (VAS); The EQ-5D-5L VAS ranges from 0 to 100, with higher scores indicating better quality of life.
Measured: From Time of enrollment until month 11.
Change from baseline in index value
Change from baseline in EQ-5D-5L Index Value The EQ-5D-5L index value ranges from -0.661 to 1, with higher scores indicating better quality of life.
Measured: From Time of enrollment until month 11.
Change from baseline in all scales of EQ-5D-5L
Change from baseline in all scales of EQ-5D-5L The scales of EQ-5D-5L range from 1 to 5, with lower scores indicating better quality of life.
Measured: From Time of enrollment until month 11.
Prevalence of ESR1 mutation
Assess prevalence of ESR1mut in patients intended for elacestrant treatment as well as the testing methodology and results for ESR1 mutations.
Measured: Baseline
Drug safety: Frequency
Frequency of specific (serious) adverse drug reactions ((S)ADRs) (nausea, vomiting, decreased appetite)
Measured: From time of treatment start until 30 days after end of elacestrant treatment
Drug safety: Incidence of adverse events
Incidence of (serious) adverse events ((S)AEs), (serious) adverse drug reactions ((S)ADRs)
Measured: From time of treatment start until 30 days after end of elacestrant treatment
Drug safety: Change from baseline in AST (Aspartate Aminotransferase)
Change from baseline in AST
Measured: From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months)
Drug safety: Change from baseline in ALT (Alanine Aminotransferase)
Change from baseline in ALT
Measured: From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months)
Drug safety: Change from baseline in bilirubin
Change from baseline in bilirubin
Measured: From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months)
Patients and disease characteristics: Age
Assess patients characteristics in patients with intention for treatment with elacestrant: Age (descriptive statistics, categorical (</≥ 65))
Measured: Baseline
Patients and disease characteristics: Body mass index (BMI)
Assess patients characteristics in patients with intention for treatment with elacestrant: BMI (descriptive statistics, categorical (underweight, normal weight, overweight, obese))
Measured: Baseline
Patients and disease characteristics: ECOG Performance status
Assess patients characteristics in patients with intention for treatment with elacestrant: ECOG Performance status
Measured: Baseline
Patients and disease characteristics: CCI (Charlson score and contributing diseases)
Assess patients characteristics in patients with intention for treatment with elacestrant: CCI (Charlson score and contributing diseases)
Measured: Baseline
Patients and disease characteristics: Time since diagnosis
Assess disease characteristics in patients with intention for treatment with elacestrant: Time since diagnosis (descriptive statistics)
Measured: Baseline
Patients and disease characteristics: TNM staging
Assess disease characteristics in patients with intention for treatment with elacestrant: TNM staging (including AJCC) at initial diagnosis
Measured: Baseline
Patients and disease characteristics: Metastatic sites
Assess disease characteristics in patients with intention for treatment with elacestrant: • Metastatic sites at inclusion
Measured: Baseline
Patients and disease characteristics: Tumor Grading
Assess disease characteristics in patients with intention for treatment with elacestrant: Tumor Grading at initial diagnosis and inclusion
Measured: Baseline
Patients and disease characteristics: HR and HER2 status
Assess disease characteristics in patients with intention for treatment with elacestrant: HR status and HER2 status at initial diagnosis and at inclusion
Measured: Baseline
Patients and disease characteristics: Prior adjuvant chemotherapy
Assess disease characteristics in patients with intention for treatment with elacestrant: Prior adjuvant chemotherapy
Measured: Baseline
Patients and disease characteristics: Prior adjuvant endocrine therapy
Assess disease characteristics in patients with intention for treatment with elacestrant: Prior adjuvant endocrine therapy
Measured: Baseline
Patients and disease characteristics: prior CDKi/endocrine therapy in the palliative setting
Assess disease characteristics in patients with intention for treatment with elacestrant: Type and duration of prior CDKi/endocrine therapy in the palliative setting (descriptive statistics, categorical ≤6 months / >6 months; ≤12 months / >12 months)
Measured: Baseline
Patients and disease characteristics: Disease site
Assess disease characteristics in patients with intention for treatment with elacestrant: Disease site (bone-only / visceral / non-visceral (not bone-only)) at inclusion
Measured: At time of enrollment
Patients and disease characteristics: concomitant diseases
Assess disease characteristics in patients with intention for treatment with elacestrant: concomitant diseases
Measured: Baseline
Use of concomitant medication
Assess the use of concomitant medication during treatment with elacestrant.
Measured: max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
Assess parameters of physicians' treatment decision making using a questionnaire
Frequency of distinct parameters affecting therapy choice; questionnaire completed by treating physician.
Measured: Baseline
Frequency of first subsequent systemic antineoplastic therapy for ESR1wt patients and ESR1mut patients without elacestrant treatment
Assess second-line treatments for all patients by ESR1 status (Frequency of first subsequent systemic antineoplastic therapy for ESR1wt patients and ESR1mut patients without elacestrant treatment (refers to first treatment received starting from second line)
Measured: max. 24 months; at patient patient-specific start of treatment
Details on treatment with elacestrant: reason for end of treatment
Assess reason for end of treatment (treatment with elacestrant)
Measured: max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
Details on treatment with elacestrant: dose intensity
Assess dose intensity (treatment with elacestrant) as prescribed by the treating physician
Measured: max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
Details on treatment with elacestrant: frequency and type of dose modification
Assess Frequency and type of dose modifications (dose reductions, interruptions) compared to SmPC of elacestrant.
Measured: max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
Details on treatment with elacestrant: reasons for dose modifications and interruptions
Assess reasons for dose modifications and interruptions (elacestrant treatment)
Measured: max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
Treatments following elacestrant therapy: Type of first subsequent systemic antineoplastic therapy
Details on treatments following elacestrant therapy (Type of first subsequent systemic antineoplastic therapy)
Measured: max. 24 months; from the patient-specific end of elacestrant treatment until end of study
Treatments following elacestrant therapy: Frequency of first subsequent systemic antineoplastic therapy
Details on treatments following elacestrant therapy:Frequency of first subsequent systemic antineoplastic therapy for ESR1mut patients (refers to first treatment received after Elacestrant so starting from third line)
Measured: max. 24 months; from the patient-specific end of elacestrant treatment until end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start19 Jun 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by iOMEDICO AGThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Berlin Chemie AG
- Responsible party
- Sponsor
- Investigators
- Thomas Decker, Professor, Principal investigator, Gemeinschaftspraxis für Hämatologie und Onkologie GbR RavensburgMichael Patrick Lux, Professor, Principal investigator, St. Louise Frauen- und Kinderklinik Paderborn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563595
- Sponsor's protocol ID
- IOM-090506
- Acronym
- ELENI
- Status last verified
- Jun 2026
- First submitted
- 2 Dec 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer: a Multicenter, National, Prospective Non-interventional Study
- ClinicalTrials.gov ID
- NCT07563595
- Acronym / sponsor ID
- ELENI / IOM-090506
- Conditions
- Breast Cancer
- Keywords
- Elacestrant, advanced breast cancer, Quality of life, ESR1 Mutation, Orserdu
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- iOMEDICO AGIndustry (pharma, biotech, devices)
- Collaborators
- Berlin Chemie AG
- Study start
- 19 Jun 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 4 May 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 objective of this non-interventional study (NIS) is to evaluate prevalence of ESR1 mutation after endocrine therapy in the palliative setting, quality of life, tolerability, and safety and to describe treatment detail and adverse event (AE) management in postmenopausal women with locally advanced and/or metastatic ER+ HER2- ESR1-mutated breast cancer and second line treatment with elacestrant according to SmPC (Summary of product characteristics) in a real-world setting.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESR1 wildtype | – | Drug: Standard of care (Investigator Choice)Patients with a ESR1 wildtype tumor |
| ESR1 mutated | – | Drug: ElacestrantPatients with a ESR1 mutated tumor |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal women with locally advanced and/or metastatic estrogen receptor-positive (ER+) human epidermal growth factor receptor 2-negative (HER2)- breast cancer with disease progression on endocrine therapy and cyclin-dependent kinase inhibitor (CDKi) and intention for second line (2L) treatment with elacestrant according to summary of product characteristics (SmPC).
Key inclusion criteria (10 listed)
- Signed and dated informed consent form
- Postmenopausal women
- Age ≥18 years
- Eastern Cooperative Oncology Group Performance Status (ECOG) < 2
- Locally advanced and/or metastatic ER+ HER2- breast cancer
Key exclusion criteria (3 listed)
- Prior chemotherapy in the advanced/metastatic setting
- Contraindications according to elacestrant SmPC, except for ESR1 test result for patients included prior to ESR1 testing.
- Participation in an interventional clinical trial within 30 days prior to enrolment or simultaneous participation in an interventional clinical trial (except follow-up phase)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElacestrantAlso: Orserdu®According to the Summary of Product Characteristics (SmPC) | Drug | ESR1 mutated |
| Standard of care (Investigator Choice)Treatment decision of investigator | Drug | ESR1 wildtype |
Primary outcome
Change from baseline in EORTC global health scale
Time frame: From Time of enrollment until month 11
Change from baseline quality of life (QoL) over time for the global health scale of the EORTC QLQ- C30 questionnaire The EORTC QLQ- C30 global health scale ranges from 0 to 100, with higher scores indicating better quality of life.
36 secondary outcomes
Time to deterioration in global health scale (EORTC QLQ-C30)
Time frame: From Time of enrollment until month 11
Time to deterioration in functional scores (EORTC QLQ-C30)
Time frame: From Time of enrollment until month 11
Time to deterioration in symptom scores (EORTC QLQ-C30)
Time frame: From Time of enrollment until month 11
Change from baseline in functional and symptom scores
Time frame: From Time of enrolment until up to 11 months after enrolment.
Change from baseline in visual analogue scale (VAS)
Time frame: From Time of enrollment until month 11.
Change from baseline in index value
Time frame: From Time of enrollment until month 11.
Change from baseline in all scales of EQ-5D-5L
Time frame: From Time of enrollment until month 11.
Prevalence of ESR1 mutation
Time frame: Baseline
Drug safety: Frequency
Time frame: From time of treatment start until 30 days after end of elacestrant treatment
Drug safety: Incidence of adverse events
Time frame: From time of treatment start until 30 days after end of elacestrant treatment
Drug safety: Change from baseline in AST (Aspartate Aminotransferase)
Time frame: From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months)
Drug safety: Change from baseline in ALT (Alanine Aminotransferase)
Time frame: From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months)
Drug safety: Change from baseline in bilirubin
Time frame: From time of treatment start until 30 days after end of elacestrant treatment (max. 24 months)
Patients and disease characteristics: Age
Time frame: Baseline
Patients and disease characteristics: Body mass index (BMI)
Time frame: Baseline
Patients and disease characteristics: ECOG Performance status
Time frame: Baseline
Patients and disease characteristics: CCI (Charlson score and contributing diseases)
Time frame: Baseline
Patients and disease characteristics: Time since diagnosis
Time frame: Baseline
Patients and disease characteristics: TNM staging
Time frame: Baseline
Patients and disease characteristics: Metastatic sites
Time frame: Baseline
Patients and disease characteristics: Tumor Grading
Time frame: Baseline
Patients and disease characteristics: HR and HER2 status
Time frame: Baseline
Patients and disease characteristics: Prior adjuvant chemotherapy
Time frame: Baseline
Patients and disease characteristics: Prior adjuvant endocrine therapy
Time frame: Baseline
Patients and disease characteristics: prior CDKi/endocrine therapy in the palliative setting
Time frame: Baseline
Patients and disease characteristics: Disease site
Time frame: At time of enrollment
Patients and disease characteristics: concomitant diseases
Time frame: Baseline
Use of concomitant medication
Time frame: max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
Assess parameters of physicians' treatment decision making using a questionnaire
Time frame: Baseline
Frequency of first subsequent systemic antineoplastic therapy for ESR1wt patients and ESR1mut patients without elacestrant treatment
Time frame: max. 24 months; at patient patient-specific start of treatment
Details on treatment with elacestrant: reason for end of treatment
Time frame: max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
Details on treatment with elacestrant: dose intensity
Time frame: max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
Details on treatment with elacestrant: frequency and type of dose modification
Time frame: max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
Details on treatment with elacestrant: reasons for dose modifications and interruptions
Time frame: max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)
Treatments following elacestrant therapy: Type of first subsequent systemic antineoplastic therapy
Time frame: max. 24 months; from the patient-specific end of elacestrant treatment until end of study
Treatments following elacestrant therapy: Frequency of first subsequent systemic antineoplastic therapy
Time frame: max. 24 months; from the patient-specific end of elacestrant treatment until end of study
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 25 Jun 2026.
- 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.
Thomas Decker, Professor principal investigator
Gemeinschaftspraxis für Hämatologie und Onkologie GbR Ravensburg
Michael Patrick Lux, Professor principal investigator
St. Louise Frauen- und Kinderklinik Paderborn
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by iOMEDICO AG at 3 sites in Germany.
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 10 inclusion and 3 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 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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 Laura Serrer (+49761152420, eleni@iomedico.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in EORTC global health scale (time frame: From Time of enrollment until month 11). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2026.