Health TrialsbyHealthPanel

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

ConditionsESR1 Gene MutationAdvanced Breast CancerSafety
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorSciClone Pharmaceuticals

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

Advanced breast cancer with ER+/HER2- and ESR1- gene mutation

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • ELacestrant

    Drug

    345 mg/day once daily oral dosing

Treatment groups

350 Participants
are divided into 1 treatment group
Group A: ELacestrant1 intervention

Trial outcomes

Primary outcomes

1

Adverse event rate

Percentage of occurrences of adverse events

Time frame
6 months

Secondary outcomes

1

Serious adverse event rate

Percentage of occurrences of serious adverse events

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SciClone Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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