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Trial Title:
CDK4/6 Inhibitors in Patients With Hormone Receptor-positive Advanced Breast Cancer
NCT ID:
NCT05795335
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Locoregionally Recurrent
Metastatic
CDK4/6 Inhibitors
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Drug
Intervention name:
CDK4/6 inhibitor
Description:
CDK4/6 inhibitors
Arm group label:
Patients have received or plan to receive CDK4/6 inhibitors for advanced disease.
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.
Criteria for eligibility:
Study pop:
Hormone receptor-positive breast cancer patients who have received or plan to receive
CDK4/6 inhibitors for advanced disease.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Address:
City:
Shanghai
Zip:
200127
Country:
China
Status:
Recruiting
Contact:
Last name:
jinsong Lu, MD
Email:
lujingsong@renji.com
Start date:
April 30, 2023
Completion date:
December 30, 2028
Lead sponsor:
Agency:
RenJi Hospital
Agency class:
Other
Source:
RenJi Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05795335
