CDK4/6 drugs for older women with breast cancer
CDK4/6 Inhibitors in Breast Cancer Elderly Patients: an Observational Ambispective Longitudinal Multicenter Study
This project will test whether CDK4/6 drugs work as well and are as safe in women aged 70 and older with breast cancer as they are in younger women, using real-world medical records and follow-up.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia, Pavia) |
| Trial ID | NCT07399808 on ClinicalTrials.gov |
What this trial studies
This is an ambispective, longitudinal observational study based at Fondazione IRCCS Policlinico San Matteo di Pavia that collects both past medical records and prospective follow-up of patients treated with CDK4/6 inhibitors. The study will compare clinical efficacy and safety outcomes between older women (primarily ≥70 years) and younger women, while accounting for comorbidities, performance status, physiological age, and frailty. Data will come from routine clinical care rather than experimental interventions, and participants must be receiving active systemic treatment with a CDK4/6 inhibitor. The aim is to better reflect real-world results in an older population that is underrepresented in randomized trials.
Who should consider this trial
Good fit: Ideal candidates are women with breast cancer who are receiving active systemic treatment with a CDK4/6 inhibitor, especially those aged 70 years or older, with younger patients included for comparison.
Not a fit: Patients who are not receiving CDK4/6 therapy, those unable to provide informed consent, or those with non-breast indications unlikely to match the study population may not gain direct benefit from this study.
Why it matters
Potential benefit: If successful, the findings could help doctors tailor CDK4/6 use and monitoring in older patients to reduce side effects and improve outcomes.
How similar studies have performed: Randomized trials have shown CDK4/6 drugs benefit many patients with hormone-receptor positive breast cancer, but dedicated real-world studies focused on patients aged 70 and older remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age over 18 years * patients with solid tumours undergoing active systemic treatment with CDK4/6 for adjuvant disease Exclusion Criteria: * Patients who are unable to understand informed consent document
Where this trial is running
Pavia, Pavia
- Fondazione IRCCS Policlinico San Matteo di Pavia — Pavia, Pavia, Italy (Recruiting)
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.