Evaluating the safety of elacestrant in advanced breast cancer patients with specific gene mutations
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
This study is testing the safety of a new drug called elacestrant in women with advanced breast cancer who have certain gene mutations and have already tried other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | SciClone Pharmaceuticals Industry-sponsored |
| Locations | 1 site (Qionghai, Hainan) |
| Trial ID | NCT06544577 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety of elacestrant in patients with advanced breast cancer who are estrogen receptor-positive (ER+), HER2-negative, and have mutations in the ESR1 gene. It will enroll female participants aged 18 and older who have progressed on at least one line of endocrine therapy. The study will collect data on patients' complaints, physical examinations, laboratory tests, imaging tests, and any adverse events related to elacestrant treatment. The goal is to gather real-world evidence on the safety profile of this treatment in a specific patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are postmenopausal women aged 18 and older with ER+/HER2- advanced breast cancer and confirmed ESR1 mutations who have previously progressed on endocrine therapy.
Not a fit: Patients who are pregnant, breastfeeding, or have known difficulties in tolerating oral medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety of elacestrant, potentially leading to improved treatment options for patients with advanced breast cancer.
How similar studies have performed: While there have been studies on elacestrant, this specific observational approach focusing on safety in a defined patient population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Qionghai, Hainan
- Hainan Hospital of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (Boao Research Hospital, Hainan) — Qionghai, Hainan, China (Recruiting)
Study contacts
- Principal investigator: Qing Qu, Doctor — Ruijin Hospital
- Study coordinator: Chunyang Li, Doctor
- Email: lichunyang@sciclone.com
- Phone: 86-15216717343
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.