NCT06544577 Safety of Elacestrant in ER+/HER2- and ESR1 Mutations MBC
| NCT ID | NCT06544577 |
| Status | Recruiting |
| Phase | — |
| Sponsor | SciClone Pharmaceuticals |
| Condition | ESR1 Gene Mutation |
| Study Type | OBSERVATIONAL |
| Enrollment | 350 participants |
| Start Date | 2024-07-13 |
| Primary Completion | 2025-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 350 participants in total. It began in 2024-07-13 with a primary completion date of 2025-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Qing Qu, Doctor
PRINCIPAL INVESTIGATOR
Ruijin Hospital
Frequently Asked Questions
Who can join the NCT06544577 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying ESR1 Gene Mutation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06544577 currently recruiting?
Yes, NCT06544577 is actively recruiting participants. Contact the research team at lichunyang@sciclone.com for enrollment information.
Where is the NCT06544577 trial being conducted?
This trial is being conducted at Qionghai, China.
Who is sponsoring the NCT06544577 clinical trial?
NCT06544577 is sponsored by SciClone Pharmaceuticals. The principal investigator is Qing Qu, Doctor at Ruijin Hospital. The trial plans to enroll 350 participants.