Evaluating CDK4/6 inhibitors for advanced breast cancer
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
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 type | Observational |
|---|---|
| Enrollment | 172 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | RenJi Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05795335 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are unable to swallow pills or have a history of immunodeficiency disease may not benefit from this study.
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 performed: Other studies have shown promising results with CDK4/6 inhibitors in similar patient populations, indicating a potential for success in this approach.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality
- Renji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Ziping Wu, MD
- Email: wuziping@renji.com
- Phone: 86(21)68385569
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.