Early Breast Cancer
Conditions
Brief summary
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.
Interventions
DRUGDalpiciclib
CDK4/6 inhibitor dalpiciclib, 100mg orally qd
DRUGEndocrine therapy
Fulvestrant/AI
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patient is ≥ 18 years-old * Patient is female with known menopausal status (postmenopausal or premenopausal/perimenopause) * Patient with histologically confirmed HR+/HER2- early breast cancer (immunohistochemical ER and/or PR≥10%) * Histologically confirmed invasive breast cancer with anatomic stages of IIA-IIIC stage (T2-4N0-3M0), of which stage IIA only included T1N1M0 * Patients with or without neoadjuvant or adjuvant chemotherapy/ radiotherapy were eligible for inclusion * From operation to enrollment should not exceed 12 months * Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Exclusion criteria
* metastatic disease (Stage IV) or inflammatory breast cancer * Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix. * Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110); * A history of allergy to the drugs in this study； * Unable or unwilling to swallow tablets * History of gastrointestinal disease with diarrhea as the major symptom.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| invasive Disease-free Survival (iDFS) | From enrollment until time of events up to 3 years | Invasive disease-free survival time is defined as the time from date of enrollment until the first disease recurrence or death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free Survival (DFS) | From enrollment until time of events up to 3 years | 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. |
| AEs and SAEs | From the first administration to one months after the last drug administration，up to one month | Adverse events and Adverse events and serious adverse events according to CACTE 5.0 |
Countries
China
Contacts
Primary ContactXiaoan Liu, Professor
Outcome results
None listed