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

February 5, 2026 updated by: Angioletta Lasagna, Fondazione IRCCS Policlinico San Matteo di Pavia

Breast cancer is one of the tumors with the highest incidence and current evidence indicates a higher prevalence in elderly patients (≥70 years) with a higher mortality rate due to immunosenescence, diagnostic delay and under treatment. Elderly patients are still poorly represented in clinical trials and the main indications for the treatment of the elderly population are extrapolated from the guidelines used in studies conducted predominantly on the younger population. In particular, these guidelines do not take into account the significant variability of elderly patients, in particular their comorbidities, performance status, physiological age and frailty.

The aim of this study is to improve understanding of the clinical efficacy and safety of CDK 4/6i in older women in a real-world setting compared to younger women.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The population of this cross-sectional study includes patients followed at the Medical Oncology Foundation IRCCS Policlinico San Matteo Pavia and Medical Oncology ICS Maugeri Pavia, suffering from solid tumors subjected to active systemic treatment with CDK4/6 for the disease in the adjuvant phase

Description

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

Study Plan

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

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the toxicity rate (both hematological and non-hematological) of any severity level in elderly patients (≥70 years) during administration of CDK 4/6i.
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
The primary objective of this study will be to evaluate the toxicity rate (both hematological and non-hematological) of any severity level in elderly patients (≥70 years) during CDK 4/6i administration. The primary endpoint will be the estimated incidence of toxicity (haematological and/or non-haematological) of any grade over a 12-month time window in elderly MBC and EBC patients (≥70 years) from our cohort of cancer patients treated with CDK 4/6i.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the toxicity rate between elderly and young MBC subjects;
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
The ratio of the toxicity rates (hematological and/or non hematological) of any degree over a time window of 12 months between elderly and younger EBC patients.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Compare the rate of switch therapies between elderly and younger EBC subjects;
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
the ratio of patients who switched therapy to the total number of treated patients.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Compare the rate of dose reductions between elderly and younger EBC subjects;
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
The ratio of patients who had a dose reduction to total number of treated patients.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Compare the invasive disease free survival (iDFS) between elderly and younger EBC subjects.
Time Frame: from the date of CDK 4/6i initiation to the date of first occurrence of ipsilateral invasive breast tumor recurrence, assessed up to 24 months
The iDFS: calculated from the date of CDK 4/6i initiation to the date of first occurrence of ipsilateral invasive breast tumor recurrence, local/regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, or second primary nonbreast invasive cancer.
from the date of CDK 4/6i initiation to the date of first occurrence of ipsilateral invasive breast tumor recurrence, assessed up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

February 5, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC_EP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe