Clinical trial Recruiting at 1 site Observational Ages 18 and up

Evaluating CDK4/6 inhibitors for advanced breast cancer

Official title: Survival Outcomes, Adverse Events and Predictive Biomarkers for CDK4/6 Inhibitors in Patients With Hormone Receptor-positive Advanced Breast Cancer, an Ambispective Single-center Cohort Study

Run by RenJi Hospital · NCT05795335 · Data updated 2026-11-12

This study is testing how well CDK4/6 inhibitors work and what side effects they cause in people with hormone receptor-positive advanced breast cancer.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment172 (estimated)
SponsorRenJi Hospital
Academic / other
Locations1 site (Shanghai, Shanghai Municipality)
StatusRecruiting
StartedApril 30, 2023
Main results expectedApril 30, 2026
Study endsDecember 30, 2028
Registry record updatedMay 16, 2023
Trial IDNCT05795335 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18 and older with hormone receptor-positive breast cancer that is locoregionally recurrent or metastatic and not suitable for curative therapy.

Probably not a fit

Patients who are unable to swallow pills or have a history of immunodeficiency disease may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the survival outcomes and adverse events associated with CDK4/6 inhibitors in patients diagnosed with hormone receptor-positive advanced breast cancer. It will also investigate potential predictive biomarkers that may influence treatment efficacy. The study is ambispective and conducted at a single center, focusing on patients who have either received or are planning to receive CDK4/6 inhibitors for their advanced disease. Participants will be monitored for their health outcomes and any side effects experienced during treatment.

Why it matters

Potential benefit: If successful, this study could provide insights into the effectiveness and safety of CDK4/6 inhibitors, potentially improving treatment strategies for patients with advanced breast cancer.

How similar studies have gone: Other studies have shown promising results with CDK4/6 inhibitors in similar patient populations, indicating a potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Aged ≥18 and older
* Confirmed diagnosis of hormone receptor-positive breast cancer.
* Subjects with locoregionally recurrent or metastatic disease not amenable to curative therapy.
* Subjects have received or plan to receive CDK4/6 inhibitors for advanced disease.
* ECOG 0-2
* Adequate organ function

Exclusion Criteria:

* Subjects disable to swallow pills.
* History of immunodeficiency disease

Where it's running

  • Renji Hospital, School of Medicine, Shanghai Jiao Tong University
    Shanghai, Shanghai Municipality, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.