Real-world Studies of CDK4/6 Inhibitors

A Real-world Study on the Treatment of HR+/HER2- Advanced Breast Cancer Patients With CDK4/6 Inhibitors and Treatment Options After Drug Resistance.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07407439

Enrollment

245

Registered

2026-02-12

Start date

2025-06-01

Completion date

2027-06-01

Last updated

2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Palbociclib, Abemaciclib, Ribociclib, Dalcetrapib, CDK4/6 inhibitors, CDK4/6 inhibitors resistance, HR+/HER2- breast cancer

Brief summary

A single-center, real-world study evaluated the clinical outcomes and safety of CDK4/6 inhibitors combined with endocrine therapy in HR+/HER2- advanced breast cancer, and conducted a summary analysis of the clinical treatment options after the progression of CDK4/6 inhibitors.

Detailed description

This study aims to collect clinical data and case information from real-world clinical practice of patients with HR+/HER2- advanced breast cancer treated with CDK4/6 inhibitors combined with endocrine therapy. The main research objectives include: 1. To evaluate the differences in efficacy among different CDK4/6 inhibitors combination regimens in advanced patients; 2. To investigate the subsequent treatment options chosen by patients in the real world after progression on CDK4/6 inhibitors, with the aim of constructing a predictive model for the response to subsequent treatments, thereby providing support for clinical decision-making for both doctors and patients in such situations. The secondary objectives include: 1. To truly reflect the differences in adverse reactions of different CDK4/6 inhibitors in the Chinese population through the collection of laboratory and imaging results; 2. To collect tumor samples or peripheral blood samples from some patients for genomic and transcriptomic analyses, in preparation for translational research on the mechanism of CDK4/6 inhibitors resistance.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age ≥ 18 years old; 2. Patients diagnosed with HR+/HER2- (as defined by the ASCO/CAP guidelines) advanced breast cancer who were treated in our hospital from March 2022 to March 2025; 3. Received CDK4/6 inhibitors (including but not limited to the four currently marketed ones: palbociclib, abemaciclib, ribociclib, and dalpiciclib) as advanced-stage treatment for at least one cycle; 4. Have complete medical history records, including demographic information, pathological reports, treatment records, laboratory test results, and imaging examination reports, etc.

Exclusion criteria

1. Incomplete medical history data. 2. Only received CDK4/6 inhibitors monotherapy. 3. Received CDK4/6 inhibitors as neoadjuvant/postoperative adjuvant intensification therapy.

Design outcomes

Primary

Measure	Time frame	Description
rwPFS1 and rwPFS2	6 weeks	Real-world progression-free survival (rwPFS1) during treatment with CDK4/6 inhibitors and real-world progression-free survival (rwPFS2) of subsequent treatment lines selected by clinicians after progression on CDK4/6 inhibitor therapy.

Countries

China

Contacts

CONTACTYehui Shi, MD

shiyehui@tjmuch.com022-23340123-3252

CONTACTYiran Si, MD

022-23340123-3252

Outcome results