Recruiting
Adjuvant CDK4/6 Inhibitor Use in HR+/HER2- Breast Cancer
To evaluate the efficacy and safety of adjuvant CDK4/6 inhibitors in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer.
ClinicalTrials.gov IDNCT07180056
PhaseNot Applicable
Enrollment229
SponsorWenjin Yin
Age18 Years
SexALL
Conditions studied
Breast Cancer
About this study
To evaluate the efficacy and safety of adjuvant CDK4/6 inhibitors in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer.
Interventions
- Drug: CDK4/6 inhibitor — abemaciclib OR ribociclib
Primary outcomes
- Invasive Disease-free Survival (iDFS) (From the date of surgery until time of event up to 2 years.)
Eligibility information
Inclusion Criteria:
* Aged ≥18 and older
* Patients with pathologically confirmed breast cancer without distant metastasis or local recurrence
* HR+/HER2-
* ECOG 0-3
* Subjects meeting current guideline recommendations and planning to receive adjuvant CDK4/6 inhibitors
Exclusion Criteria:
* During pregnancy or lactation
* Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption
Study locations
- Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 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.