Real-world Studies of CDK4/6 Inhibitors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Real-world Study on the Treatment of HR+/HER2- Advanced Breast Cancer Patients With CDK4/6 Inhibitors and Treatment Options After Drug Resistance.
Overview
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.
Primary outcome measures
- rwPFS1 and rwPFS2 [Time frame: 6 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Tianjin Medical University Cancer Insititute and Hospital — Tianjin
Identifiers
NCT: NCT07407439 · TJMUCIH-BC-CDK4/6i-01