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This study is a multi-center, observational, real-world study. We planned to recruit 420 HR+ locally advanced or metastatic breast cancer patients who had received or had not received prior systemic therapy. All patients included in the analysis were receiving or planning to receive dalpiciclib-containing regimens without restrictions, completely following the physician 's clinical choice, to assess the efficacy and safety of dalpiciclib-containing regimens.
All patients included in the analysis were receiving or were planning to receive dalpiciclib and other standard therapy, with no restrictions on the regimen and full adherence to physician clinical choices. Patients who qualified after completing the screening tests and assessments entered the study treatment period and were treated and visited with a dalpiciclib -containing regimen as specified in the protocol. Patients underwent imaging assessments and safety assessments according to clinical routine during study treatment, with the investigator 's assessment as the final result.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| locally advanced/metastatic HR+ breast cancer patients | HR+ postmenopausal or premenopausal and locally advanced or metastatic breast cancer patients who had received or had not received prior systemic therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dalpiciclib | Drug | a new, orally administered, selective CDK4/6 inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS | progression free survival | 2 years |
| AE | the incidence of adverse event | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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HR+ postmenopausal/premenopausal locally advanced/metastatic breast cancer patients who had received or had not received prior systemic therapy were planned to be enrolled in the study
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| cuizhi Geng Cuizhi Geng, archiater | Contact | +8613503216325 | gengcuizhi@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Cuizhi Geng Cuizhi Geng, archiater | Hebei Medical University Fourth Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fourth hospital of Hebei University | Recruiting | Shijiazhuang | Hebei | 050011 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C000720752 | dalpiciclib |
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| D017437 |
| Skin and Connective Tissue Diseases |