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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy |
| ||
| Endocrine therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endocrine therapy | Drug | All endocrine treatment regimens approved for advanced breast cancer, including tamoxifen, aromatase inhibitors, fulvestrant, etc. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression-free survival | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate | 6 months |
| CBR | Clinical benefit rate | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event rate | Percentage of occurrences of adverse events | 18 months |
| Serious adverse event rate | Percentage of occurrences of serious adverse events |
Inclusion Criteria:
Exclusion Criteria:
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Patients with HR+/HER2-advanced breast cancer with ESR1 mutation after failure of endocrine therapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunyang Li | Contact | 86-15216717343 | lichunyang@sciclone.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Haidafu Internet Hospital | Recruiting | Suzhou | Jiangsu | China |
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| Chemotherapy Prednisone | Drug | All chemotherapy treatment regimens approved for advanced breast cancer |
|
| DoR | Duration of response | 18 months |
| 18 months |
| Treatment regimen | Proportion of endocrine therapy, endocrine-targeted combination therapy or chemotherapy | 18 months |
| Medication adherence | proportion of days covered | 18 months |