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

NCT05979220 | Not Yet Recruiting Phase 2

• 1 other identifier: OBU-SC-BC-II-015
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Progression Free Survival 2(PFS2)

  Estimated up to 27-31 months

Other Outcomes (6)

• Overall Survival(OS)

  Estimated up to 5 years

• Objective Response Rate（ORR）

  Estimated up to 23 months

• Clinical Benefit Rate (CBR)

  Estimated up to 23 months

Study Arms (1)

Dalpiciclib combined with Letrozole

EXPERIMENTAL

Dalpiciclib combined with Letrozole,28 days as one cycle. 1. Dalpiciclib: 150 mg (p.o.) was given once daily for 3 weeks, followed by 1 week off in each 4-week cycle. 2. Letrozole: 2.5mg, p.o., once a day, continuous administration.

Drug: Dalpiciclib combined with Letrozole

Interventions

Dalpiciclib combined with Letrozole DRUG

A multicenter, single arm, prospective Phase II clinical study

Dalpiciclib combined with Letrozole

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shuangyue Liu: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Ting Luo, post-doctor

CONTACT

18602866299; tina621@163.com

Xiaorong Zhong, post-doctor

CONTACT

18980605984; zhongxiaorong@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: August 7, 2023
• Study Start: December 1, 2023
• Primary Completion: June 30, 2024
• Study Completion (Estimated): June 30, 2028
• Last Updated: August 7, 2023

Record last verified: 2023-08

Locations

CN (1)