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To evaluate the efficacy and safety of dalpiciclib in patients with HR-positive/HER2-positive advanced breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dalpiciclib | dalpiciclib oral day 1-21, every 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dalpiciclib | Drug | dalpiciclib oral day 1-21, every 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | The time from the date of starting dalpiciclib to the date of disease progression as per RECIST version 1.1 or death from any cause, whichever occurs first. | From the date of starting dalpiciclib to the date of first documentation of progression or death (up to approximately 1 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Adverse events during dalpiciclib treatment will be assessed according to the NCI CTCAE v5.0. | From the date of starting dalpiciclib to the end of the treatment (up to approximately 1 year) |
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Inclusion Criteria:
Exclusion Criteria:
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Hormone receptor-positive and human epidermal growth factor receptor 2-negative advanced breast cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenjin Yin | Contact | 86(21)68385569 | yinwenjin@renji.com |
| Name | Affiliation | Role |
|---|---|---|
| Wenjin Yin | Renji Hospital, School of Medicine, Shanghai Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital, School of Medicine, Shanghai Jiaotong University | Recruiting | Shanghai | 200127 | China |
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| ID | Term |
|---|---|
| C000720752 | dalpiciclib |
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