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

Breast Cancer Clinical Trial

Official title:

Survival Outcomes, Adverse Events and Predictive Biomarkers for CDK4/6 Inhibitors in Patients With Hormone Receptor-positive Advanced Breast Cancer, an Ambispective Single-center Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05795335
• Other study ID #: KY2022-097-B
• Status: Recruiting
• Start date: April 30, 2023
• Est. completion date: December 30, 2028

Study information

• Verified date: May 2023
• Source: RenJi Hospital
• Contact: Ziping Wu, MD
• Phone: 86(21)68385569
• Email: wuziping[@]renji.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 172
• Est. completion date: December 30, 2028
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• CDK4/6 inhibitor
CDK4/6 inhibitors

Locations

Country	Name	City	State
China	Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS)	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.	From the date of starting CDK4/6 inhibitor to the date of first documentation of progression or death (up to approximately 2.5 years)
Secondary	Overall survival	Overall survival is defined as the time from starting CDK4/6 inhibitor to death from any cause.	From the date of starting CDK4/6 inhibitor until death from any cause up to 3 years
Secondary	Adverse events	Adverse events during CDK4/6 regimen will be assessed according to the NCI CTCAE v5.0.	From the date of starting CDK4/6 inhibitor to the end of the treatment (up to approximately 2.5 years)