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

• Sponsor: Shuangyue Liu (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05979220
• Collaborator: (none)
• Enrollment: 178
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 55
• Patients Per Site Per Month: 3.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Dalpiciclib combined with Letrozole	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 178 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Dec 1, 2023
• Anticipated Primary Completion Date: Jun 30, 2024
• Anticipated Study Completion Date: Jun 30, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dalpiciclib combined with Letrozole 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.	Drug: Dalpiciclib combined with Letrozole; A multicenter, single arm, prospective Phase II clinical study

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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 Outcome Measures

1. 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

2. 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)

3. 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.

4. 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).

5. 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

6. Adverse events (AEs) [Estimated up to 5 years]

   The drug safety was assessed by investigator(s) according to NCI-CTCAE v5.0.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West China Hospital, Sichuan University	Chengdu	Sichuan	China

Sponsors and Collaborators

• Shuangyue Liu

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shuangyue Liu, Clinical Professor, West China Hospital
• ClinicalTrials.gov Identifier: NCT05979220
• Other Study ID Numbers: OBU-SC-BC-II-015
• First Posted: Aug 7, 2023
• Last Update Posted: Aug 7, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms; Letrozole

Study Results

No Results Posted as of Aug 7, 2023