Clinical Efficacy and Safety of CDK4/6 Inhibitors in Elderly Breast Cancer Patients
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.
Data Collection
Collected from today forward - ProspectiveBreast Diseases+3
+ Breast Neoplasms
+ Neoplasms
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.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
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, ItalyOpen Fondazione IRCCS Policlinico San Matteo di Pavia in Google Maps