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NCT07076680 | RECRUITING | Breast Cancer Metastatic

A Real-World Study of Elacestrant in Patients With HR+/HER2- Advanced Breast Cancer and ESR1 Mutations
Sponsor:

SciClone Pharmaceuticals

Brief Summary:

The goal of this observational study is to learn about the safety and effectiveness of elacestrant in people with advanced breast cancer that is hormone receptor-positive (HR+), HER2-negative (HER2-), and has a mutation in the ESR1 gene. The main questions it aims to answer are: How safe is elacestrant when used in real-world clinical settings? How well does elacestrant work in controlling disease in people with ESR1 mutations? Participants will: Already be prescribed elacestrant by their doctor as part of regular treatment Allow researchers to collect medical data during routine care Be followed for signs of treatment effectiveness and any medical problems that happen while taking the drug This study will help researchers better understand how elacestrant is used and how well it works in real-life healthcare settings in China.

Condition or disease

Breast Cancer Metastatic

HR+/HER2- Advanced Breast Cancer

ESR1 Gene Mutation

Elaacestrant

Study Type : OBSERVATIONAL
Estimated Enrollment : 100 participants
Official Title : Safety and Effectiveness of Elacestrant in Patients With HR+/HER2-, ESR1-mutated Advanced Breast Cancer: a Prospective, Noninterventional Real-world Study
Actual Study Start Date : 2025-08-01
Estimated Primary Completion Date : 2027-02-01
Estimated Study Completion Date : 2027-07-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * 1\. must have a histologically or cytologically confirmed diagnosis of breast cancer and evidence of locally advanced or metastatic disease that is not amenable to surgical resection.
  • 2\. Women or men ≥ 18 years of age. 3. must be confirmed as HR+ and HER2- by local laboratory tests. Confirmation of this status can be done by a first visit tissue sample or a post-treatment sample (recent biopsy sample preferred if available).
  • 4\. Testing to confirm ESR1 mutation positivity should be performed on tumor DNA taken from tissue samples or circulating tumor DNA (ctDNA) obtained from plasma samples using a well-validated assay. Accept the results of the central laboratory or local laboratory tests, and in the event of inconsistency between the two test results, the investigator determines whether enrollment is possible.
  • 5\. previous treatment with at least one endocrine therapy, either as monotherapy or in combination with another drug, at an advanced stage.
  • 6\. have a life expectancy greater than 3 months and normal organ function (as assessed by the investigator).
Exclusion Criteria
  • \- 1. Pregnant or lactating females. 2. Known difficulty tolerating oral medications, or the presence of conditions that would interfere with the absorption of oral medications or allergies to medications and their excipients.
  • 3\. Other conditions that the investigator considers inappropriate for enrollment.
A Real-World Study of Elacestrant in Patients With HR+/HER2- Advanced Breast Cancer and ESR1 Mutations

Location Details

NCT07076680

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How to Participate

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Locations

RECRUITING

China,

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, China,