Safety of Elacestrant in ER+/HER2- and ESR1 Mutations MBC

Launched by SCICLONE PHARMACEUTICALS · Aug 5, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the safety of a treatment called elacestrant for women with advanced breast cancer that is hormone receptor-positive (ER+) and HER2-negative, specifically those with a mutation in the ESR1 gene. The study aims to gather information on how patients are feeling, their physical health, and any side effects they may experience while receiving elacestrant. This research is important to better understand how safe this treatment is in a real-world setting.

To be eligible for the trial, participants must be postmenopausal women aged 18 or older who have been diagnosed with advanced breast cancer that cannot be treated with surgery or radical radiation. They should have already tried at least one other hormone therapy treatment and have confirmed ESR1 mutations. The study is currently recruiting participants, and it’s important to note that women who are pregnant or breastfeeding, or who have certain medical conditions affecting oral medication, cannot join the trial. Participants can expect regular check-ups to monitor their health and any side effects during the study.

Gender

FEMALE

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