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NCT Number: NCT07563595

Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Praxis für interdisziplinäre Onkologie & Hämatologie, Freiburg im Breisgau, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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))
  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Elacestrant

Drug

According to the Summary of Product Characteristics (SmPC)

Other names: Orserdu®

Standard of Care (Investigator Choice)

Drug

Treatment decision of investigator

Primary outcomes

  1. 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.

Secondary outcomes

  1. Time to deterioration in global health scale (EORTC QLQ-C30)

    Time frame: From Time of enrollment until month 11

    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.

  2. Time to deterioration in functional scores (EORTC QLQ-C30)

    Time frame: From Time of enrollment until month 11

    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.

  3. Time to deterioration in symptom scores (EORTC QLQ-C30)

    Time frame: From Time of enrollment until month 11

    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.

  4. 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 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.

  5. Change from baseline in visual analogue scale (VAS)

    Time frame: From Time of enrollment until month 11.

    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.

  6. Change from baseline in index value

    Time frame: From Time of enrollment until month 11.

    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.

  7. Change from baseline in all scales of EQ-5D-5L

    Time frame: From Time of enrollment until month 11.

    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.

  8. Prevalence of ESR1 mutation

    Time frame: Baseline

    Assess prevalence of ESR1mut in patients intended for elacestrant treatment as well as the testing methodology and results for ESR1 mutations.

  9. Drug safety: Frequency

    Time frame: From time of treatment start until 30 days after end of elacestrant treatment

    Frequency of specific (serious) adverse drug reactions ((S)ADRs) (nausea, vomiting, decreased appetite)

  10. Drug safety: Incidence of adverse events

    Time frame: From time of treatment start until 30 days after end of elacestrant treatment

    Incidence of (serious) adverse events ((S)AEs), (serious) adverse drug reactions ((S)ADRs)

  11. 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)

    Change from baseline in AST

  12. 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)

    Change from baseline in ALT

  13. 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)

    Change from baseline in bilirubin

  14. Patients and disease characteristics: Age

    Time frame: Baseline

    Assess patients characteristics in patients with intention for treatment with elacestrant: Age (descriptive statistics, categorical (</≥ 65))

  15. Patients and disease characteristics: Body mass index (BMI)

    Time frame: Baseline

    Assess patients characteristics in patients with intention for treatment with elacestrant: BMI (descriptive statistics, categorical (underweight, normal weight, overweight, obese))

  16. Patients and disease characteristics: ECOG Performance status

    Time frame: Baseline

    Assess patients characteristics in patients with intention for treatment with elacestrant: ECOG Performance status

  17. Patients and disease characteristics: CCI (Charlson score and contributing diseases)

    Time frame: Baseline

    Assess patients characteristics in patients with intention for treatment with elacestrant: CCI (Charlson score and contributing diseases)

  18. Patients and disease characteristics: Time since diagnosis

    Time frame: Baseline

    Assess disease characteristics in patients with intention for treatment with elacestrant: Time since diagnosis (descriptive statistics)

  19. Patients and disease characteristics: TNM staging

    Time frame: Baseline

    Assess disease characteristics in patients with intention for treatment with elacestrant: TNM staging (including AJCC) at initial diagnosis

  20. Patients and disease characteristics: Metastatic sites

    Time frame: Baseline

    Assess disease characteristics in patients with intention for treatment with elacestrant: • Metastatic sites at inclusion

  21. Patients and disease characteristics: Tumor Grading

    Time frame: Baseline

    Assess disease characteristics in patients with intention for treatment with elacestrant: Tumor Grading at initial diagnosis and inclusion

  22. Patients and disease characteristics: HR and HER2 status

    Time frame: Baseline

    Assess disease characteristics in patients with intention for treatment with elacestrant: HR status and HER2 status at initial diagnosis and at inclusion

  23. Patients and disease characteristics: Prior adjuvant chemotherapy

    Time frame: Baseline

    Assess disease characteristics in patients with intention for treatment with elacestrant: Prior adjuvant chemotherapy

  24. Patients and disease characteristics: Prior adjuvant endocrine therapy

    Time frame: Baseline

    Assess disease characteristics in patients with intention for treatment with elacestrant: Prior adjuvant endocrine therapy

  25. Patients and disease characteristics: prior CDKi/endocrine therapy in the palliative setting

    Time frame: Baseline

    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)

  26. Patients and disease characteristics: Disease site

    Time frame: At time of enrollment

    Assess disease characteristics in patients with intention for treatment with elacestrant: Disease site (bone-only / visceral / non-visceral (not bone-only)) at inclusion

  27. Patients and disease characteristics: concomitant diseases

    Time frame: Baseline

    Assess disease characteristics in patients with intention for treatment with elacestrant: concomitant diseases

  28. Use of concomitant medication

    Time frame: max. 24 months; from the patient-specific study start to end of study (during elacestrant treatment)

    Assess the use of concomitant medication during treatment with elacestrant.

  29. Assess parameters of physicians' treatment decision making using a questionnaire

    Time frame: Baseline

    Frequency of distinct parameters affecting therapy choice; questionnaire completed by treating physician.

  30. 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

    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)

  31. 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)

    Assess reason for end of treatment (treatment with elacestrant)

  32. 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)

    Assess dose intensity (treatment with elacestrant) as prescribed by the treating physician

  33. 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)

    Assess Frequency and type of dose modifications (dose reductions, interruptions) compared to SmPC of elacestrant.

  34. 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)

    Assess reasons for dose modifications and interruptions (elacestrant treatment)

  35. 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

    Details on treatments following elacestrant therapy (Type of first subsequent systemic antineoplastic therapy)

  36. 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

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Serrer

CONTACT

[email protected]

+49761152420

Sponsors and collaborators

Lead sponsor

iOMEDICO AG

Industry

Collaborators

  • Berlin Chemie AG

Registry information

Official study title

Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer: a Multicenter, National, Prospective Non-interventional Study

Acronym: ELENI

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 4, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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