Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigator conduct a phase II multi-center, open-label trial to evaluate efficacy and safety of dalpiciclib with endocrine therapy as adjuvant treatment in patients with medium /high risk hormone receptor-positive, HER2-negative Early Breast Cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Dalpiciclib and endocrine therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dalpiciclib | Drug | CDK4/6 inhibitor dalpiciclib, 100mg orally qd |
|
| Measure | Description | Time Frame |
|---|---|---|
| invasive Disease-free Survival (iDFS) | Invasive disease-free survival time is defined as the time from date of enrollment until the first disease recurrence or death from any cause | From enrollment until time of events up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Survival (DFS) | Disease-free survival time is defined as the time from date of enrollment until the first disease recurrence(including carcinoma in situ)or death from any cause. | From enrollment until time of events up to 3 years |
| AEs and SAEs |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoan Liu, Professor | Contact | 025-68308162 | liuxiaoan@126.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000720752 | dalpiciclib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Endocrine therapy | Drug | Fulvestrant/AI |
|
Adverse events and Adverse events and serious adverse events according to CACTE 5.0 |
| From the first administration to one months after the last drug administration,up to one month |
| D017437 |
| Skin and Connective Tissue Diseases |