Elacestrant use in ER+ HER2- ESR1-mutated advanced or metastatic breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This non-interventional study describes how patients with locally advanced or metastatic ER+ HER2- cancer carrying ESR1 mutations are treated with elacestrant in routine care. It aims to document prevalence of ESR1 mutations after endocrine therapy, quality of life, tolerability, safety, and how treatment and adverse events are managed. Participants are postmenopausal women with limited prior endocrine therapy exposure, receiving elacestrant per SmPC or investigator choice, with informed consent and standard clinical assessments. Data collection focuses on real-world treatment details and outcomes rather than a controlled experimental protocol.

Why it matters

Who can join: the full rules

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)

Where it's running

• Praxis für interdisziplinäre Onkologie & Hämatologie
  Freiburg im Breisgau, Germany Recruiting
• St. Louise Frauen- und Kinderklinik
  Paderborn, Germany Recruiting
• Gemeinschaftspraxis für Hämatologie und Onkologie
  Ravensburg, Germany Recruiting

Study contacts

• Principal investigator: Thomas Decker, Professor — Gemeinschaftspraxis für Hämatologie und Onkologie GbR Ravensburg
• Study coordinator: Laura Serrer
• Email: eleni@iomedico.com
• Phone: +49761152420

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.