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NCT Number: NCT07399808

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Old Age Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

    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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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