Breast Cancer
Conditions
Keywords
Locoregionally Recurrent, Metastatic, CDK4/6 Inhibitors
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.
Interventions
DRUGCDK4/6 inhibitor
CDK4/6 inhibitors
Sponsors
RenJi Hospital
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactZiping Wu, MD
Backup ContactQi Lu
Outcome results
None listed