Clinical trial · Observational
Safety of Elacestrant in ER+/HER2- and ESR1 Mutations MBC
Safety of Elacestrant in the Treatment of Advanced Breast Cancer Patients With ER+/HER2- and ESR1-mutations Who Have Progressed on at Least One Line of Endocrine Therapy: a Prospective, Non-interventional Real-world 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)
This study is a prospective non-interventional real-world study enrolling patients with advanced breast cancer who are ER+/HER2- and have ESR1- gene mutations, collecting information on patients' complaints, physical examination, laboratory tests, imaging tests and adverse events to observe the safety of elacestrant treatment.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| ESR1 Gene Mutation | — | UNRESOLVED | — |
| Safety | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ELacestrant | Drug | Elacestrant | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- ELacestrant
- description
- Subjects in this cohort will receive elacestrant
- interventionNames
- Drug: ELacestrant
Primary outcomes (1)
- measure
- Adverse event rate
- timeFrame
- 6 months
- description
- Percentage of occurrences of adverse events
Secondary outcomes (1)
- measure
- Serious adverse event rate
- timeFrame
- 6 months
- description
- Percentage of occurrences of serious adverse events
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. must have a histologically or cytologically confirmed diagnosis of breast cancer with evidence of locally advanced disease unsuitable for excision or radical radiotherapy, or evidence of metastatic disease unsuitable for radical treatment. * 2\. female ≥ 18 years of age * 3\. female subjects must be postmenopausal (meeting any of the following criteria is sufficient) a) Has undergone oophorectomy. b) Age ≥ 60 years. c) 40 years old \< age ≤ 60 years old with 1 year of menopause. d) Age \<60 years and receiving ovarian suppression therapy. * 4\. ER-positive and HER2-negative status and ESR1-mutation positive must be confirmed. * 5\. must have progressed on at least one line of endocrine therapy prior to enrollment, including monotherapy or combination therapy. * 6\. have normal organ function (as assessed by the investigator). Exclusion Criteria: * 1\. women who are pregnant or breastfeeding * 2\. known difficulties in tolerating oral medications, or conditions that interfere with the absorption of oral medications or allergies to medications and their excitements * 3\. other conditions that make enrollment in the study unsuitable, at the discretion of the investigator
References
Publications (0)
Data not yet available