Breast CancerNCT07407439
Real-world Studies of CDK4/6 Inhibitors
An observational study of Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 245 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- 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.
Who cannot join
- Incomplete medical history data.
- Only received CDK4/6 inhibitors monotherapy.
- Received CDK4/6 inhibitors as neoadjuvant/postoperative adjuvant intensification therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yiran Si, MD contact
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Insititute and Hospital
Tianjin, 300060
Yehui Shi, MD, 022-23340124-3252, shiyehui@tjmuch.com
About this study
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.
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.
Read the 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.
- Conditions
- Breast Cancer
- Keywords
- Palbociclib, Abemaciclib, Ribociclib, Dalcetrapib, CDK4/6 inhibitors, CDK4/6 inhibitors resistance, HR+/HER2- breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 Jun 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 245 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407439
- Sponsor's protocol ID
- TJMUCIH-BC-CDK4/6i-01
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the stage of result publication, we will provide the IPD data in accordance with the specific requirements from the ICMJE journal.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07407439
- Acronym / sponsor ID
- TJMUCIH-BC-CDK4/6i-01
- Conditions
- Breast Cancer
- Keywords
- Palbociclib, Abemaciclib, Ribociclib, Dalcetrapib, CDK4/6 inhibitors, CDK4/6 inhibitors resistance, HR+/HER2- breast cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 245 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Incomplete medical history data.
- Only received CDK4/6 inhibitors monotherapy.
- Received CDK4/6 inhibitors as neoadjuvant/postoperative adjuvant intensification therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
rwPFS1 and rwPFS2
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: Yes. At the stage of result publication, we will provide the IPD data in accordance with the specific requirements from the ICMJE journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yiran Si, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yehui Shi, MD (022-23340123-3252, shiyehui@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rwPFS1 and rwPFS2 (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.