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

NCT07563595 | Not Yet Recruiting

• 1 other identifier: IOM-090506
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

Brief 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 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

Keywords

Elacestrant; advanced breast cancer; Quality of life; ESR1 Mutation; Orserdu

Outcome Measures

Primary Outcomes (1)

• 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.

  From Time of enrollment until month 11

Secondary Outcomes (36)

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

  From Time of enrollment until month 11

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

  From Time of enrollment until month 11

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

  From Time of enrollment until month 11

• Change from baseline in functional and symptom scores

  From Time of enrolment until up to 11 months after enrolment.

• Change from baseline in visual analogue scale (VAS)

  From Time of enrollment until month 11.

Study Arms (2)

ESR1 wildtype

Patients with a ESR1 wildtype tumor

Drug: Standard of care (Investigator Choice)

ESR1 mutated

Patients with a ESR1 mutated tumor

Drug: Elacestrant

Interventions

Elacestrant DRUG

According to the Summary of Product Characteristics (SmPC)

Also known as: Orserdu®

ESR1 mutated

Standard of care (Investigator Choice) DRUG

Treatment decision of investigator

ESR1 wildtype

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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).

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• iOMEDICO AG: lead
• Berlin Chemie AG: collaborator

Study Sites (2)

St. Louise Frauen- und Kinderklinik

Paderborn, 33098, Germany

Location

Gemeinschaftspraxis für Hämatologie und Onkologie

Ravensburg, 88212, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

elacestrant; Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Thomas Decker, Professor

  Gemeinschaftspraxis für Hämatologie und Onkologie GbR Ravensburg

  PRINCIPAL INVESTIGATOR

• Michael Patrick Lux, Professor

  St. Louise Frauen- und Kinderklinik Paderborn

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Serrer

CONTACT

+49761152420; eleni@iomedico.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: May 4, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)