Clinical trial · Observational
CDK4/6 Inhibitors in Breast Cancer Elderly Patients: an Observational Ambispective Longitudinal Multicenter Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Old Age | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Evaluate the toxicity rate (both hematological and non-hematological) of any severity level in elderly patients (≥70 years) during administration of CDK 4/6i.
- timeFrame
- 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
- description
- 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 (4)
- measure
- Compare the toxicity rate between elderly and young MBC subjects;
- timeFrame
- 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
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available