Study of Dalpiciclib Combined With Letrozole in the Maintenance Treatment of HR Positive and HER2 Negative Metastatic Breast Cancer After First-line Chemotherapy

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05979220
• Other study ID #: OBU-SC-BC-II-015
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 1, 2023
• Est. completion date: June 30, 2028

Study information

• Verified date: August 2023
• Source: West China Hospital
• Contact: Ting Luo, post-doctor
• Phone: 18602866299
• Email: tina621[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 178
• Est. completion date: June 30, 2028
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Dalpiciclib combined with Letrozole
A multicenter, single arm, prospective Phase II clinical study

Locations

Country	Name	City	State
China	West China Hospital, Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Shuangyue Liu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall Survival(OS)	OS was defined as the time from the first study treatment to the date of death from any cause	Estimated up to 5 years
Other	Objective Response Rate(ORR)	Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)	Estimated up to 23 months
Other	Clinical Benefit Rate (CBR)	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.	Estimated up to 23 months
Other	Disease Control Rate (DCR)	Disease Control Rate (DCR) was defined as the percentage of patients with a complete response (CR), partial response (PR) and stable disease (SD).	Estimated up to 23 months
Other	Patient Reported Outcome (PRO)	Using the European Five Dimensional Health Scale (EQ-5D) to allow patients to self-evaluate their quality of life	Estimated up to 5 years
Other	Adverse events (AEs)	The drug safety was assessed by investigator(s) according to NCI-CTCAE v5.0.	Estimated up to 5 years
Primary	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.	Estimated up to 23 months
Secondary	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.	Estimated up to 27-31 months