Advanced Breast Cancer, ESR1 Gene Mutation
Conditions
Brief summary
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.
Interventions
DRUGEndocrine therapy
All endocrine treatment regimens approved for advanced breast cancer, including tamoxifen, aromatase inhibitors, fulvestrant, etc.
DRUGChemotherapy Prednisone
All chemotherapy treatment regimens approved for advanced breast cancer
Sponsors
SciClone Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 18 months | Progression-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 6 months | Objective response rate |
| CBR | 6 months | Clinical benefit rate |
| DoR | 18 months | Duration of response |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse event rate | 18 months | Percentage of occurrences of adverse events |
| Serious adverse event rate | 18 months | Percentage of occurrences of serious adverse events |
| Treatment regimen | 18 months | Proportion of endocrine therapy, endocrine-targeted combination therapy or chemotherapy |
| Medication adherence | 18 months | proportion of days covered |
Countries
China
Contacts
Primary ContactChunyang Li
Outcome results
None listed