CDK4/6 Inhibitors in Patients With Hormone Receptor-positive Advanced Breast Cancer

Recruiting

• Conditions: Breast Cancer
• Interventions: Drug: CDK4/6 inhibitor

• Registration Number: NCT05795335
• Lead Sponsor: RenJi Hospital

Brief Summary

This is an ambispective, single-center study to evaluate the survival outcomes, adverse events and predictive biomarkers for CDK4/6 inhibitors in patients with hormone receptor-positive advanced breast cancer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-21
• Study First Submitted QC: 2023-03-21
• Study First Posted: 2023-04-03
• Study Start: 2023-04-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-14
• Last Update Posted: 2023-05-16
• Primary Completion: 2026-04-30
• Study Completion: 2028-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

• Aged ≥18 and older
• Confirmed diagnosis of hormone receptor-positive breast cancer.
• Subjects with locoregionally recurrent or metastatic disease not amenable to curative therapy.
• Subjects have received or plan to receive CDK4/6 inhibitors for advanced disease.
• ECOG 0-2
• Adequate organ function

Exclusion Criteria

• Subjects disable to swallow pills.
• History of immunodeficiency disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients have received or plan to receive CDK4/6 inhibitors for advanced disease.	CDK4/6 inhibitor	-

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	From the date of starting CDK4/6 inhibitor to the date of first documentation of progression or death (up to approximately 2.5 years)	PFS is defined as the time from the date of starting CDK4/6 inhibitor to the date of objective tumor progression as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) or death from any cause in the absence of documented PD, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
Overall survival	From the date of starting CDK4/6 inhibitor until death from any cause up to 3 years	Overall survival is defined as the time from starting CDK4/6 inhibitor to death from any cause.
Adverse events	From the date of starting CDK4/6 inhibitor to the end of the treatment (up to approximately 2.5 years)	Adverse events during CDK4/6 regimen will be assessed according to the NCI CTCAE v5.0.

Trial Locations

Locations (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China