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 and older
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.