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RecruitingNCT06544577Updated Aug 9, 2024

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

An observational study in ESR1 Gene Mutation, Advanced Breast Cancer and Safety, sponsored by SciClone Pharmaceuticals. Recruiting at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-09.

Sponsored by SciClone Pharmaceuticals · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started Jul 2024; still recruiting 2 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
350
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • ESR1 Gene Mutation
  • Advanced Breast Cancer
  • Safety

Browse trials for

03

In context

Breast Neoplasms

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

This study's planned enrollment of 350 is above the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

SciClone Pharmaceuticals is the lead sponsor of 16 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    1. must have a or cytologically confirmed diagnosis of breast cancer with evidence of locally advanced disease unsuitable for excision or radical radiotherapy, or evidence of disease unsuitable for radical treatment.
    1. female ≥ 18 years of age
    1. female subjects must be (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.
    1. ER-positive and -negative status and ESR1-mutation positive must be confirmed.
    1. must have progressed on at least one line of endocrine therapy prior to enrollment, including monotherapy or combination therapy.
    1. have normal organ function (as assessed by the investigator).

Exclusion criteria

Exclusion Criteria:

    1. women who are pregnant or breastfeeding
    1. known difficulties in tolerating oral medications, or conditions that interfere with the absorption of oral medications or allergies to medications and their excitements
    1. other conditions that make enrollment in the study unsuitable, at the discretion of the investigator
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

HER2

HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.

In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
350 participants (estimated)
Patient registry
No

Groups and cohorts

  • ELacestrant

    Subjects in this cohort will receive elacestrant

    Drug: ELacestrant

Interventions

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • Hainan Hospital of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (Boao Research Hospital, Hainan)
    Qionghai, Hainan, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2024 (actual). Primary completion is estimated for Aug 2025, 12 months after the start.

Of 189 industry-sponsored observational studies under Breast Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 70. This study's planned 12 months is below that.

Counting every sponsor, half of 1,380 studies reached it within 55 months; a quarter within 25 and three quarters within 126.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 5, 2024
First posted
Aug 9, 2024
StartActual
Jul 13, 2024
Primary completionEst.
Aug 1, 2025
CompletionEst.
Aug 1, 2026
Last update
Aug 9, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06544577
Lead sponsor
SciClone Pharmaceuticals
Responsible party
Sponsor
First posted
Aug 9, 2024
Start date
Jul 13, 2024
Primary completion
Aug 1, 2025 (estimated)
Completion
Aug 1, 2026 (estimated)
Last update
Aug 9, 2024

Study contacts

Chunyang Li, Doctor
Contact
lichunyang@sciclone.com
86-15216717343
Qing Qu, Doctor
principal investigator · Ruijin Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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