Real-world Studies of CDK4/6 Inhibitors | NCT07407439

Studies
Real-world Studies of CDK4/6 Inhibitors

NCT07407439

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Status

Recruiting

Last Update Posted

Feb 12, 2026Actual

Enrollment

245Estimated

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2025Actual

Primary Completion Date

Jun 1, 2026Estimated

Completion Date

Jun 1, 2027Estimated

First Submitted Date

Feb 5, 2026

First Submission Date that Met QC Criteria

Feb 5, 2026

First Posted Date

Feb 12, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2026

Last Update Posted Date

Feb 12, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

245Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yehui Shi, MD	Contact	022-23340123-3252		shiyehui@tjmuch.com
Yiran Si, MD	Contact	022-23340123-3252

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tianjin Medical University Cancer Insititute and Hospital	Recruiting	Tianjin		300060	China

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

At the stage of result publication, we will provide the IPD data in accordance with the specific requirements from the ICMJE journal.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP_ICF	Yes	Yes	Yes	Study Protocol, Statistical Analysis Plan, and Informed Consent Form	Jan 25, 2026	Feb 5, 2026	Prot_SAP_ICF_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided