Back to resultsStudy of Dalpiciclib Combined With Letrozole in the Maintenance Treatment of HR Positive and HER2 Negative Metastatic Breast Cancer After First-line Chemotherapy
Primary Purpose
Breast Cancer
Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Dalpiciclib combined with Letrozole
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria: Has the pathologically-confirmed diagnosis of locally recurrent or metastatic, hormone-receptor positive, HER2 negative Breast Cancer. Age: 18 - 75 years old Eastern Cooperative Oncology Group performance status (ECOG PS)=0~1 Functions of liver and kidney is normal Agreed to take contraceptive measures during treatment Exclusion Criteria: Confirmed diagnosis of HER2 positive disease. Central nervous system metastasis Patients who received prior treatment with any CDK4/6 inhibitor. 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； Researchers believe that is not suitable for the study
Sites / Locations
- West China Hospital, Sichuan University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dalpiciclib combined with Letrozole
Arm Description
Dalpiciclib combined with Letrozole,28 days as one cycle. Dalpiciclib: 150 mg (p.o.) was given once daily for 3 weeks, followed by 1 week off in each 4-week cycle. Letrozole: 2.5mg, p.o., once a day, continuous administration.
Outcomes
Primary Outcome Measures
Progression Free Survival (PFS)
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 Outcome Measures
Progression Free Survival 2(PFS2)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05979220
Brief Title
Study of Dalpiciclib Combined With Letrozole in the Maintenance Treatment of HR Positive and HER2 Negative Metastatic Breast Cancer After First-line Chemotherapy
Official Title
A Multicenter, Single Arm, Prospective Phase II Clinical Study of Dalpiciclib Combined With Letrozole in the Maintenance Treatment of HR Positive and HER2 Negative Metastatic Breast Cancer After First-line Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shuangyue Liu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
178 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dalpiciclib combined with Letrozole
Arm Type
Experimental
Arm Description
Dalpiciclib combined with Letrozole,28 days as one cycle.
Dalpiciclib: 150 mg (p.o.) was given once daily for 3 weeks, followed by 1 week off in each 4-week cycle.
Letrozole: 2.5mg, p.o., once a day, continuous administration.
Intervention Type
Drug
Intervention Name(s)
Dalpiciclib combined with Letrozole
Intervention Description
A multicenter, single arm, prospective Phase II clinical study
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
Estimated up to 23 months
Secondary Outcome Measure Information:
Title
Progression Free Survival 2(PFS2)
Description
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.
Time Frame
Estimated up to 27-31 months
Other Pre-specified Outcome Measures:
Title
Overall Survival(OS)
Description
OS was defined as the time from the first study treatment to the date of death from any cause
Time Frame
Estimated up to 5 years
Title
Objective Response Rate（ORR）
Description
Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)
Time Frame
Estimated up to 23 months
Title
Clinical Benefit Rate (CBR)
Description
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.
Time Frame
Estimated up to 23 months
Title
Disease Control Rate (DCR)
Description
Disease Control Rate (DCR) was defined as the percentage of patients with a complete response (CR), partial response (PR) and stable disease (SD).
Time Frame
Estimated up to 23 months
Title
Patient Reported Outcome (PRO)
Description
Using the European Five Dimensional Health Scale (EQ-5D) to allow patients to self-evaluate their quality of life
Time Frame
Estimated up to 5 years
Title
Adverse events (AEs)
Description
The drug safety was assessed by investigator(s) according to NCI-CTCAE v5.0.
Time Frame
Estimated up to 5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has the pathologically-confirmed diagnosis of locally recurrent or metastatic, hormone-receptor positive, HER2 negative Breast Cancer.
Age: 18 - 75 years old
Eastern Cooperative Oncology Group performance status (ECOG PS)=0~1
Functions of liver and kidney is normal
Agreed to take contraceptive measures during treatment
Exclusion Criteria:
Confirmed diagnosis of HER2 positive disease.
Central nervous system metastasis
Patients who received prior treatment with any CDK4/6 inhibitor.
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；
Researchers believe that is not suitable for the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ting Luo, post-doctor
Phone
18602866299
Email
tina621@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaorong Zhong, post-doctor
Phone
18980605984
Email
zhongxiaorong@126.com
Facility Information:
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ting Luo, MD
Phone
18602866299
Ext
+86
Email
tina621@163.com
12. IPD Sharing Statement
Learn more about this trial
Study of Dalpiciclib Combined With Letrozole in the Maintenance Treatment of HR Positive and HER2 Negative Metastatic Breast Cancer After First-line Chemotherapy
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