An observational study in ESR1 Gene Mutation and Advanced Breast Cancer, sponsored by SciClone Pharmaceuticals. Recruiting at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-12.
Sponsored by SciClone Pharmaceuticals · Observational
This is a prospective, non-interventional real-world study to observe the efficacy and safety of different treatment regimens in patients with ESR1-mutated HR+/HER2-advanced breast cancer after failure of endocrine therapy.
Epidemiological data, efficacy and safety measures will be collected for each subject. Data on efficacy and safety assessment indicators will be collected every 2-3 months until disease progression, receipt of a new anti-tumour treatment modality, death, loss to follow-up, and arrival at the data collection cut-off date. The cut-off date for data collection is defined as 8 weeks after completion of 6 visits for each subject, or 4 weeks after treatment discontinuation and subject discontinuation/withdrawal. Subjects receiving a different treatment regimen remained subject to assessment of safety indicators 4 weeks after discontinuation of the original treatment regimen.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 450 is above the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →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.
Patients with HR+/HER2-advanced breast cancer with ESR1 mutation after failure of endocrine therapy
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.
Exclusion Criteria:
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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 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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Endocrine therapy
Drug: Chemotherapy Prednisone
All endocrine treatment regimens approved for advanced breast cancer, including tamoxifen, aromatase inhibitors, fulvestrant, etc.
All chemotherapy treatment regimens approved for advanced breast cancer
This study also gives Fulvestrant. No intervention listed here names it: that was found by reading the record.
PFS
Progression-free survival
Time frame: 18 months
ORR
Objective response rate
Time frame: 6 months
CBR
Clinical benefit rate
Time frame: 6 months
DoR
Duration of response
Time frame: 18 months
Adverse event rate
Percentage of occurrences of adverse events
Time frame: 18 months
Serious adverse event rate
Percentage of occurrences of serious adverse events
Time frame: 18 months
Treatment regimen
Proportion of endocrine therapy, endocrine-targeted combination therapy or chemotherapy
Time frame: 18 months
Medication adherence
proportion of days covered
Time frame: 18 months
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2024 (actual). Primary completion is estimated for Dec 2026, 28 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 28 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.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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SciClone Pharmaceuticals