Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Elacestrant, Standard of care (Investigator Choice).
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer: a Multicenter, National, Prospective Non-interventional Study
Overview
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.
Interventions
- Drug Elacestrant
According to the Summary of Product Characteristics (SmPC) - Drug Standard of care (Investigator Choice)
Treatment decision of investigator
Primary outcome measures
- Change from baseline in EORTC global health scale [Time frame: From Time of enrollment until month 11]
Secondary outcome measures (12)
- 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)]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Germany · 3 centers
- Praxis für interdisziplinäre Onkologie & Hämatologie — Freiburg im Breisgau
- St. Louise Frauen- und Kinderklinik — Paderborn
- Gemeinschaftspraxis für Hämatologie und Onkologie — Ravensburg
Identifiers
NCT: NCT07563595 · IOM-090506