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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Dalpiciclib combined with Letrozole

• Study Type: Interventional
• Enrollment (Estimated): 178
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xiaorong Zhong, post-doctor; Phone Number: 18980605984; Email: zhongxiaorong@126.com
• Study Contact Backup: Name: Ting Luo, post-doctor; Phone Number: 18602866299; Email: tina621@163.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital, Sichuan University
      • Contact: Ting Luo, MD; Phone Number: +86 18602866299; Email: tina621@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Adverse events (AEs)	The drug safety was assessed by investigator(s) according to NCI-CTCAE v5.0.	Estimated up to 5 years

Collaborators and Investigators

• Sponsor: Shuangyue Liu

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: May 19, 2023
• First Submitted That Met QC Criteria: August 3, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Letrozole
• Other Study ID Numbers: OBU-SC-BC-II-015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No