Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer
Recruiting
Observational Study
Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Observational
- Participants needed
- 500 (estimated)
- Sponsor
- iOMEDICO AG · Industry
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About This Trial
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 …
Trial Locations
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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 immu…
Contacts