Clinical trial · Observational
Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer
Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer: a Multicenter, National, Prospective Non-interventional Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Elacestrant | Drug | Elacestrant | ALIAS |
| Standard of care (Investigator Choice) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- ESR1 wildtype
- description
- Patients with a ESR1 wildtype tumor
- interventionNames
- Drug: Standard of care (Investigator Choice)
- label
- ESR1 mutated
- description
- Patients with a ESR1 mutated tumor
- interventionNames
- Drug: Elacestrant
Primary outcomes (1)
- measure
- Change from baseline in EORTC global health scale
- timeFrame
- From Time of enrollment until month 11
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available