Clinical trial Recruiting at 1 site Observational Ages 18 and up

CDK4/6 drugs for older women with breast cancer

Official title: CDK4/6 Inhibitors in Breast Cancer Elderly Patients: an Observational Ambispective Longitudinal Multicenter Study

Run by Fondazione IRCCS Policlinico San Matteo di Pavia · NCT07399808 · Data updated 2026-11-12

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.

More Breast Cancer trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorFondazione IRCCS Policlinico San Matteo di Pavia
Academic / other
Locations1 site (Pavia, Pavia)
StatusRecruiting
StartedMarch 21, 2025
Main results expectedMarch 2026
Study endsDecember 2026
Registry record updatedFebruary 10, 2026
Trial IDNCT07399808 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

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

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Fondazione IRCCS Policlinico San Matteo di Pavia
    Pavia, Pavia, Italy
    Recruiting

Similar studies

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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.