Breast Cancer
Conditions
Brief summary
This study aimed to evaluate the efficacy and safety of Dalpiciclib combined with Letrozole in the maintenance treatment of HR positive and HER2 negative metastatic breast cancer after first-line chemotherapy.
Interventions
DRUGDalpiciclib combined with Letrozole
A multicenter, single arm, prospective Phase II clinical study
Sponsors
Shuangyue Liu
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
1. Has the pathologically-confirmed diagnosis of locally recurrent or metastatic, hormone-receptor positive, HER2 negative Breast Cancer. 2. Age: 18 - 75 years old 3. Eastern Cooperative Oncology Group performance status (ECOG PS)=0\ 1 4. Functions of liver and kidney is normal 5. Agreed to take contraceptive measures during treatment
Exclusion criteria
1. Confirmed diagnosis of HER2 positive disease. 2. Central nervous system metastasis 3. Patients who received prior treatment with any CDK4/6 inhibitor. 4. Clinically significant cardiovascular and cerebrovascular diseases,including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class \> 2), or ventricular arrhythmia which need medical intervention； 5. Researchers believe that is not suitable for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | Estimated up to 23 months | The time from the enrollment of the subject until the first recording of tumor progression (evaluated according to RECIST 1.1 criteria) or death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival 2(PFS2) | Estimated up to 27-31 months | The time from the first chemotherapy for the metastatic stage by the subject to the first recording of tumor progression (evaluated according to RECIST 1.1 standards) or death from any cause. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate（ORR） | Estimated up to 23 months | Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR) |
| Clinical Benefit Rate (CBR) | Estimated up to 23 months | The percentage of participants who received study treatment and evaluated the best overall efficacy according to RECIST 1.1 criteria as complete remission (CR), partial remission (PR), and disease stability (SD) ≥ 24 weeks. |
| Disease Control Rate (DCR) | Estimated up to 23 months | Disease Control Rate (DCR) was defined as the percentage of patients with a complete response (CR), partial response (PR) and stable disease (SD). |
| Patient Reported Outcome (PRO) | Estimated up to 5 years | Using the European Five Dimensional Health Scale (EQ-5D) to allow patients to self-evaluate their quality of life |
| Adverse events (AEs) | Estimated up to 5 years | The drug safety was assessed by investigator(s) according to NCI-CTCAE v5.0. |
| Overall Survival(OS) | Estimated up to 5 years | OS was defined as the time from the first study treatment to the date of death from any cause |
Countries
China
Contacts
Primary ContactTing Luo, post-doctor
Backup ContactXiaorong Zhong, post-doctor
Outcome results
None listed