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

Launched by SCICLONE PHARMACEUTICALS · Jul 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medicine called elacestrant in people with advanced breast cancer that is hormone receptor-positive (HR+) and HER2-negative (HER2-), and who have a specific change (mutation) in a gene called ESR1. The goal is to see how safe elacestrant is and how well it works when used in everyday medical care. Researchers want to learn if elacestrant helps control the cancer and what side effects might happen when patients take it outside of a controlled trial setting.

People who may join this study are adults with advanced breast cancer confirmed by tests, including those whose cancer has spread and cannot be treated with surgery. They must have the HR+/HER2- type of breast cancer and a confirmed ESR1 gene mutation. Participants will already be prescribed elacestrant by their doctor as part of their usual treatment. During the study, researchers will collect medical information from regular doctor visits to monitor how well the treatment is working and to watch for any side effects. This study is currently recruiting patients in China and will help doctors understand how elacestrant performs in real life, beyond clinical trials.

Gender

ALL

Eligibility 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.