Recruiting

Clinical Efficacy and Safety of CDK4/6 Inhibitors in Elderly Breast Cancer Patients

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Study Aim

This study aims to evaluate the toxicity rate, both hematological and non-hematological, of any severity level in elderly patients (aged 70 years and above) during the administration of CDK 4/6 inhibitors for breast cancer treatment.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Breast Diseases+3

+ Breast Neoplasms

+ Neoplasms

Over 18 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: March 2025
See protocol details

Summary

Principal SponsorFondazione IRCCS Policlinico San Matteo di Pavia
Last updated: February 11, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 21, 2025

Actual date on which the first participant was enrolled.

This study focuses on breast cancer, a disease with a high occurrence rate, especially in elderly patients aged 70 and above. The study aims to address the current gap in understanding the effects of a specific class of drugs, known as CDK 4/6 inhibitors (CDK 4/6i), in this age group. Current treatment guidelines for breast cancer are largely based on studies conducted on younger populations, which may not account for the unique health conditions, physical abilities, and aging factors of elderly patients. This research aims to provide a clearer picture of how CDK 4/6i can benefit and impact older women in real-world settings, potentially leading to improved care and treatment strategies tailored to their needs. During the study, participants will be monitored to evaluate the safety and effectiveness of CDK 4/6i. The primary goal is to assess the rate of side effects, both blood-related and non-blood-related, of any severity level in elderly patients while they are taking CDK 4/6i. The study will measure the incidence of these side effects over a 12-month period in elderly patients with both early and advanced breast cancer who are part of the patient cohort receiving CDK 4/6i treatment.

Official TitleCDK4/6 Inhibitors in Breast Cancer Elderly Patients: an Observational Ambispective Longitudinal Multicenter Study
Principal SponsorFondazione IRCCS Policlinico San Matteo di Pavia
Last updated: February 11, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Criteria

2 inclusion criteria required to participate
age over 18 years

patients with solid tumours undergoing active systemic treatment with CDK4/6 for adjuvant disease

1 exclusion criteria prevent from participating
Patients who are unable to understand informed consent document

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, ItalyOpen Fondazione IRCCS Policlinico San Matteo di Pavia in Google Maps
Recruiting
One Study Center