CDK4/6 Inhibitors in Breast Cancer Elderly Patients: an Observational Ambispective Longitudinal Multicenter Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Old Age. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- 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]
Secondary outcome measures (4)
- 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]
- 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]
- 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]
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Fondazione IRCCS Policlinico San Matteo di Pavia — Pavia
Identifiers
NCT: NCT07399808 · BC_EP