Real-world Studies of CDK4/6 Inhibitors

NCT07407439 | Recruiting

• 1 other identifier: TJMUCIH-BC-CDK4/6i-01
• Study Type: observational
• Target: 245
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• rwPFS1 and rwPFS2

  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.

  6 weeks

Study Arms (5)

Palbociclib cohort

Use palbociclib in combination with endocrine therapy as the treatment regimen.

Abemaciclib cohort

Use abemaciclib in combination with endocrine therapy as the treatment regimen.

Ribociclib cohort

Use ribociclib in combination with endocrine therapy as the treatment regimen.

Dalcetrapib cohort

Use dalcetrapib in combination with endocrine therapy as the treatment regimen.

Other CDK4/6 inhibitors cohort

Use other CDK4/6 inhibitors in combination with endocrine therapy (including participation in clinical trials of CDK4/6 inhibitors) as the treatment regimen.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who were diagnosed as HR+/HER2- (as defined by the ASCO/CAP guidelines) advanced breast cancer between March 2022 to March 2025

You may qualify if:

• Age ≥ 18 years old;
• 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;
• 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;
• Have complete medical history records, including demographic information, pathological reports, treatment records, laboratory test results, and imaging examination reports, etc.

You may not qualify if:

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

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Insititute and Hospital

Tianjin, 300060, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

We will collect the residual tumor samples or peripheral blood samples of the patients in our hospital for genomic and transcriptomic analyses, etc., to prepare for the translational research on the mechanism of CDK4/6i resistance.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Yehui Shi, MD

CONTACT

022-23340123-3252; shiyehui@tjmuch.com

Yiran Si, MD

CONTACT

022-23340123-3252

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 12, 2026
• Study Start: June 1, 2025
• Primary Completion: June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)