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

NCT07399808 | Recruiting

• 1 other identifier: BC_EP
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Old Age

Outcome Measures

Primary Outcomes (1)

• Evaluate the toxicity rate (both hematological and non-hematological) of any severity level in elderly patients (≥70 years) during administration of CDK 4/6i.

  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 Outcomes (4)

• Compare the toxicity rate between elderly and young MBC subjects;

  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;

  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;

  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.

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• age over 18 years
• patients with solid tumours undergoing active systemic treatment with CDK4/6 for adjuvant disease

You may not qualify if:

• Patients who are unable to understand informed consent document

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Pavia, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oncologist

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: February 10, 2026
• Study Start: March 21, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2025-12

Locations

IT (1)