Recruiting
CDK4/6 Inhibitors in Patients With Hormone Receptor-positive Advanced Breast Cancer
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.
ClinicalTrials.gov IDNCT05795335
PhaseNot Applicable
Enrollment172
SponsorRenJi Hospital
Age18 Years
SexALL
Conditions studied
Breast Cancer
About this study
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
- Drug: CDK4/6 inhibitor — CDK4/6 inhibitors
Primary outcomes
- 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))
Eligibility information
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 locations
- Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, Shanghai Municipality 200127 China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.