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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia, Pavia) |
| Status | Recruiting |
| Started | March 21, 2025 |
| Main results expected | March 2026 |
| Study ends | December 2026 |
| Registry record updated | February 10, 2026 |
| Trial ID | NCT07399808 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
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Gyrotonic exercise for elders with breast cancer and Behcet disease
We’re testing whether a gyrotonic exercise program helps older people who have both Behcet disease and breast cancer.
-
PECS II vs SPSIP nerve blocks for pain after mastectomy
This study tests whether two ultrasound-guided nerve blocks (PECS II and SPSIP) differ in how much opioid patients need after mastectomy.
-
CG-7321: a first-in-human test in advanced solid tumors
We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.
-
Compare a new endoscopy-assisted breast-conserving surgery with the usual approach
This study tests whether a new endoscopy-assisted breast-conserving technique can provide similar or better cosmetic outcomes and safety compared with conventional breast-conserving surgery in women with early breast cancer who want to preserve their breast.
-
Different skin care approaches to prevent skin reactions after mastectomy radiation
This study tests three standard skin care methods to see which best prevents radiation dermatitis in people who had a mastectomy and are receiving post-mastectomy radiation therapy.
-
3D Heart Strain to Detect Early Cardiotoxicity in Cancer Therapy
This study tests whether 3D echocardiography can detect early heart damage from cancer treatments like anthracyclines or HER2-targeted therapy better than standard 2D methods.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.